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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04945460
Other study ID # 7962-007
Secondary ID A011-16MK-7962-0
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 29, 2021
Est. completion date February 20, 2027

Study information

Verified date June 2024
Source Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Contact Toll Free Number
Phone 1-888-577-8839
Email Trialsites@merck.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).


Description:

Participants enrolled in the study will have a diagnosis of Cpc-PH due to HFpEF with New York Heart Association (NYHA) functional class (FC) II or III. Participants will be randomly assigned in a 1:1:1 ratio to 1 of the 3 treatment groups (placebo, 0.3mg/kg sotatercept and 0.7mg/kg sotatercept) during the placebo-controlled Treatment Period. In the extension phase, sotatercept-treated participants will continue on their current dose. Placebo participants will be re-randomized in a 1:1 ratio to one of the two sotatercept treatment groups utilized in the placebo-controlled Treatment Period. Each participant will be enrolled in the study for up to 114 weeks, including a 28-day Screening Period, a 24-week, double-blind, placebo-controlled Treatment Period, an 18-month Extension Period, and an 8-week Follow-up Period.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date February 20, 2027
Est. primary completion date October 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: Participants must meet the following criteria to be enrolled in this proof-of-concept study: 1. Age 18 to 85 years 2. Clinical diagnosis of HFpEF: • Left ventricular ejection fraction =50%, with no history of LVEF below 45% in more than two consecutive measurements under stable conditions 3. Demonstrated Cpc-PH by all of the following: - Baseline RHC performed within 28 days of randomization documenting a minimum PVR of =320 dyn•sec/cm5 (4 wood units) - Mean pulmonary arterial pressure (mPAP) of >20 mmHg - Pulmonary capillary wedge pressure (PCWP) >15 mmHg but < 30 mmHg 4. New York Heart Association FC of II or III 5. Six-minute Walk Distance =100 m repeated twice during Screening and both values within 15% of each other, calculated from the highest value 6. Chronic medication for HF or for any underlying condition, administered at a stable (per investigator) dose for =30 days prior to Visit 1. Diuretics and/or anticoagulants are excepted from this rule but should not be newly started or stopped within 30 days of Visit 1, and a prescribed dose change should not occur within 7 days of Visit 1. Anticoagulation may be suspended for RHC if necessary. 7. Women of childbearing potential must: - Have 2 negative urine or serum pregnancy tests as verified by the investigator during the Screening Period; must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug - If sexually active with a male partner: use highly effective contraception without interruption for at least 28 days prior to starting the investigational product AND agree to use the same highly effective contraception in combination with a barrier method during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study treatment - Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study drug 8. Male participants must: - Agree to use a condom, defined as a male latex condom or non latex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy - Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study drug 9. Ability to adhere to the study visit schedule and understand and comply with all protocol requirements 10. Agreement to not participate in any other trials of investigational drugs/devices while enrolled in the A011-16 study 11. Ability to understand and provide documented consent for participation Exclusion Criteria: Participants will be excluded from the study if any of the following criteria are met: 1. A diagnosis of PH in WHO Group 1, WHO Group 3, WHO Group 4, or WHO Group 5 2. Clinically significant and active lung disease: - Chronic obstructive pulmonary disease with post-bronchodilator forced expiratory volume in the first second (FEV1) <60% predicted - Restrictive lung disease with total lung capacity <70% predicted - More than mild interstitial lung disease (ILD), with FVC<70% or FEV1<60% predicted (still appropriate if absence of more than mild ILD, fibrosis, or COPD on computed tomography [CT] imaging) 3. Cardiovascular co-morbidities, which include any of the following: - History of more than mild mitral or aortic stenosis - Ongoing more than mild mitral or aortic regurgitation - More than one valve replacement or repair (mechanical or biomechanical) or anticipation of any valve replacement or repair - Severe tricuspid regurgitation due to primary valvular disease - Occurrence of myocardial infarction, acute coronary syndrome, coronary artery bypass graft or percutaneous coronary intervention within 180 days of Visit 1 - History of serious life-threatening or hemodynamically significant arrhythmia - History of or anticipated heart transplant or ventricular assist device implantation - History of implantable cardioverter defibrillator placement or anticipated implantation of pacemaker, pacemaker implantation within 30 days of Screening - Anticipated implantation of pacemaker, pacemaker implantation within 30 days of Screening or history of implantable cardioverter defibrillator placement - Occurrence of myocardial infarction within 180 days of Visit 1 - History of known pericardial constriction, hypertrophic cardiomyopathy, sarcoidosis, or amyloid cardiomyopathy - Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure >160 mmHg or sitting diastolic blood pressure >110 mmHg during Screening after a period of rest - Systemic hypotension as evidenced by sitting systolic blood pressure <90 mmHg or sitting diastolic blood pressure <50 mmHg during Screening - Resting heart rate of <45 bpm or >115 bpm - Stroke within 90 days of Visit 1 - Acutely decompensated HF that required hospitalization within 30 days of Visit 1 - Electrocardiogram during Screening Period with Fridericia's corrected QT interval (QTcF) >470 msec for males or >480 msec for females, or >500 msec if a ventricular conduction defect (right bundle branch block; left bundle branch block; or interventricular conduction delay) is present - Personal or family history of Brugada syndrome, sudden cardiac arrest or unexplained sudden cardiac death or arrest - Personal or family history of long QT syndrome unless the participant's ECG shows a normal QTc - Arrhythmogenic right ventricular dysplasia (ARVD) unless the participant has a recent cardiac MRI that shows no evidence of this diagnosis 4. Hospitalization for any worsening of medical conditions or any significant surgery per investigator within 30 days of Visit 1. 5. Received any approved PAH-specific therapies (i.e., endothelin receptor antagonists, prostacyclin analogs, phosphodiesterase-5 inhibitors, soluble guanylate cyclase stimulators) within 30 days of Visit 1.The use of an oral phosphodiesterase type 5 inhibitor, if only indicated for erectile dysfunction, is permitted, if not administered within 48 hours of a study visit or procedure. 6. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin,or levosimendan) within 30 days of Visit 1 7. Received erythropoietin within 6 months of Visit 1. 8. Known history of chronic liver disease, including untreated hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), with severe hepatic impairment and/or cirrhosis (e.g., hepatic encephalopathy) 9. Prior exposure to sotatercept or luspatercept. 10. Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for investigational biologics prior to the date of documented consent. 11. Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days of Visit 1 or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible). 12. Any of the following clinical laboratory values prior to Visit 1 as specified: - Hemoglobin (Hgb) above the gender-specific upper limit of normal (ULN) per local laboratory test within 28 days of Visit 1or <10 g/dL per local laboratory within 28 days of Visit 1 - Serum alanine aminotransferase or aspartate aminotransferase levels >3× ULN or total bilirubin >3× ULN within 28 days of Visit 1 - Estimated glomerular filtration rate <30 ml/min/1.73 m2 (4-variable Modification of Diet in Renal Disease equation) within 28 days of Visit 1 or required renal replacement therapy within 90 days of Visit 1 - Glycated hemoglobin (HbA1c) >10% within 28 days of Visit 1 - Platelet count < 75,000/mm3 within 28 days of Visit 1 13. History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in the investigational product . 14. Major surgery within 60 days of Visit 1. Participants must have completely recovered from any previous surgery prior to Visit 1. 15. Prior organ transplantation (e.g., heart, lung, liver, kidney), bone marrow transplantation, or life expectancy of < 12 months. 16. Pregnancy or breastfeeding in females. 17. Active malignancy, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in situ, or = 2 squamous cell carcinomas of the skin. 18. History of clinically significant (as determined by the investigator) endocrine, hematologic, hepatic, (auto)immune, infectious (requiring chronic antibiotics), metabolic, urologic, pulmonary, neurologic, neuromuscular, dermatologic, psychiatric, renal, and/or another disease that may limit participation in the study. 19. Body mass index =50 kg/m2. 20. More than mild obstructive sleep apnea (treated or untreated). 21. Any non-cardiopulmonary condition or acute/chronic impairment(s) (other than dyspnea) that limits the ability to perform 6-minute walk test (6MWT).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sotatercept 0.3 mg/kg
Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.
Placebo
Administered by subcutaneous injection
Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg
Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.

Locations

Country Name City State
Belgium Hôpital Erasme ( Site 1402) Anderlecht Bruxelles-Capitale, Region De
Belgium UZ Leuven - Campus Gasthuisberg ( Site 1401) Leuven Vlaams-Brabant
Canada University Of Alberta ( Site 2101) Edmonton Alberta
Canada Hamilton General Hospital-Special Immunology Services Clinic ( Site 2110) Hamilton Ontario
Canada Institut Universitaire de Cardiologie et de Pneumologie ( Site 2107) Sainte Foy Quebec
Canada University Health Network ( Site 2109) Toronto Ontario
France CHU Angers ( Site 1313) Angers Maine-et-Loire
France Centre Hospitalier Universitaire du Besancon ( Site 1324) Besançon Doubs
France Centre Hospitalier Universitaire de Grenoble ( Site 1303) Grenoble cedex 09 Isere
France Centre Hospitalier Universitaire de Bicetre ( Site 1304) Le Kremlin Bicêtre Val-de-Marne
France CHRU Lille ( Site 1306) Lille Nord
France CHU Montpellier Hôpital Arnaud de VIlleneuve ( Site 1301) Montpellier Herault
France CHU de Nantes - Hoptal Nord Laennec ( Site 1309) Nantes Loire-Atlantique
France Hôpital Pasteur - CHU Nice ( Site 1311) Nice Alpes-Maritimes
France Hôpital Pontchaillou ( Site 1319) Rennes Ille-et-Vilaine
France CHU de Rouen ( Site 1323) Rouen Seine-Maritime
France Hopital de Rangueil du Toulouse ( Site 1322) Toulouse Haute-Garonne
France CHRU de Nancy Hopitaux de Brabois ( Site 1308) Vandœuvre-lès-Nancy Meurthe-et-Moselle
Germany Kerckhoff-Klinik-Forschungs-GmbH ( Site 1514) Bad Nauheim Hessen
Germany DRK Kliniken Berlin Westend ( Site 1507) Berlin
Germany Uniklinik Köln ( Site 1511) Cologne Nordrhein-Westfalen
Germany Universitätsklinikum Carl Gustav Carus an der TU Dresden. ( Site 1501) Dresden Sachsen
Germany Universitätsklinikum Gießen und Marburg GmbH ( Site 1512) Gießen Hessen
Germany Medizinische Hochschule Hannover ( Site 1505) Hannover Niedersachsen
Germany Thoraxklinik-Heidelberg gGmbH ( Site 1509) Heidelberg Baden-Wurttemberg
Germany Universitaetsmedizin Johannes Gutenberg Universitaet Mainz ( Site 1515) Mainz Rheinland-Pfalz
Germany Krankenhaus Neuwittelsbach ( Site 1510) München Bayern
Germany University Hospital Regensburg ( Site 1503) Regensburg Bayern
Israel Assuta Ashdod Medical Center ( Site 1710) Ashdod
Israel Shamir Medical Center Assaf Harofeh ( Site 1713) Be'er Ya'akov
Israel Lady Davis Carmel Medical Center ( Site 1705) Haifa
Israel Rambam Health Corp. ( Site 1716) Haifa
Israel Edith Wolfson Medical Center ( Site 1717) Holon
Israel Hadassah Ein Kerem Medical Center ( Site 1711) Jerusalem
Israel Shaare Zedek Medical Center ( Site 1715) Jerusalem
Israel Meir Medical Center ( Site 1707) Kfar Saba
Israel Rabin Medical Center ( Site 1703) Petah Tiqwa
Israel Kaplan Medical Center ( Site 1712) Rehovot
Israel ZIV Medical Center ( Site 1704) Safed
Israel Tel Aviv Sourasky Medical Center ( Site 1714) Tel Aviv
Italy ASST Papa Giovanni XXIII ( Site 2410) Bergamo
Italy AOU di Bologna Policlinico S Orsola Malpighi ( Site 2409) Bologna Emilia-Romagna
Italy Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406) Monza Lombardia
Italy Fondazione IRCCS-Policlinico San Matteo ( Site 2401) Pavia Lombardia
Italy Azienda Policlinico Umberto I ( Site 2402) Roma
Italy Ospedale SS Annunziata ( Site 2408) Sassari Sardegna
Italy Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405) Trieste Friuli-Venezia Giulia
Poland Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 2803) Bialystok Podlaskie
Poland Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2801) Krakow Malopolskie
Poland Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 2806) Lubin Lubelskie
Poland Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802) Otwock Mazowieckie
Poland Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie ( Site 2804) Szczecin Zachodniopomorskie
Poland Panstwowy Instytut Medyczny MSWiA ( Site 2805) Warszawa Mazowieckie
Spain Hospital Clinic de Barcelona ( Site 1602) Barcelona
Spain Hospital Universitario 12 de Octubre ( Site 1603) Madrid
Spain Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604) Majadahonda Madrid
Spain Hospital Costa del Sol ( Site 1613) Marbella Malaga
Spain Hospital Universitario Virgen Macarena ( Site 1612) Sevilla
Spain Hospital Universitario de Toledo ( Site 1607) Toledo
Sweden Sahlgrenska Universitetssjukhuset ( Site 3201) Goteburg Vastra Gotalands Lan
United Kingdom Imperial College Healthcare NHS Trust ( Site 1203) London London, City Of
United States University of Michigan ( Site 1011) Ann Arbor Michigan
United States Emory University ( Site 1030) Atlanta Georgia
United States Piedmont Atlanta Hospital ( Site 1085) Atlanta Georgia
United States University Of Colorado ( Site 1013) Aurora Colorado
United States Saint Alphonsus Regional Medical Center ( Site 1097) Boise Idaho
United States Brigham and Women's Hospital [Boston, MA] ( Site 1014) Boston Massachusetts
United States Tufts Medical Center - PPDS ( Site 1012) Boston Massachusetts
United States Bay Area Cardiology ( Site 1071) Brandon Florida
United States Medical University of South Carolina - PPDS ( Site 1003) Charleston South Carolina
United States University of Illinois Hospital ( Site 1095) Chicago Illinois
United States The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001) Cincinnati Ohio
United States Cleveland Clinic Foundation ( Site 1065) Cleveland Ohio
United States University Hospitals Cleveland Medical Center ( Site 1005) Cleveland Ohio
United States The Ohio State University Wexner Medical Center ( Site 1032) Columbus Ohio
United States Duke University Medical Center ( Site 1026) Durham North Carolina
United States Rhode Island Hospital ( Site 1033) East Providence Rhode Island
United States Inova Heart and Vascular Institute ( Site 1078) Falls Church Virginia
United States Ascension Medical Group St. Vincent ( Site 1076) Indianapolis Indiana
United States IU Health Advanced Heart and Lung Care ( Site 1092) Indianapolis Indiana
United States University of Iowa Hospital and Clinics ( Site 1050) Iowa City Iowa
United States Mayo Clinic Jacksonville - PPDS ( Site 1045) Jacksonville Florida
United States University of Kansas Medical Center ( Site 1020) Kansas City Kansas
United States Statcare Pulmonary Consultants - Knoxville ( Site 1031) Knoxville Tennessee
United States South Denver Cardiology Associates ( Site 1091) Littleton Colorado
United States Pulmonary Health Physicians ( Site 1080) Liverpool New York
United States Cedars Sinai Medical Center ( Site 1082) Los Angeles California
United States Norton Pulmonary Specialists ( Site 1066) Louisville Kentucky
United States Aurora St Luke's Medical Center ( Site 1083) Milwaukee Wisconsin
United States Froedtert Hospital & the Medical College of Wisconsin ( Site 1051) Milwaukee Wisconsin
United States University of Minnesota Hospitals ( Site 1062) Minneapolis Minnesota
United States West Virginia University ( Site 1081) Morgantown West Virginia
United States Intermountain Medical Center ( Site 1079) Murray Utah
United States Winchester Chest Clinic ( Site 1093) New Haven Connecticut
United States University Medical Center New Orleans ( Site 1057) New Orleans Louisiana
United States Weill Cornell Medical College ( Site 1046) New York New York
United States University of Nebraska Medical Center ( Site 1053) Omaha Nebraska
United States University of California Irvine ( Site 1086) Orange California
United States AdventHealth Orlando ( Site 1058) Orlando Florida
United States PULMONARY ASSOCIATES, P.A. ( Site 1008) Phoenix Arizona
United States Allegheny General Hospital ( Site 1088) Pittsburgh Pennsylvania
United States Oregon Health Science University ( Site 1054) Portland Oregon
United States Bon Secours St. Mary's Hospital ( Site 1069) Richmond Virginia
United States University of Rochester Medical Center - PPDS ( Site 1039) Rochester New York
United States Washington University School of Medicine [Saint Louis, MO] ( Site 1022) Saint Louis Missouri
United States Jeffrey S.Sager MD Medical Corporation ( Site 1060) Santa Barbara California
United States Stanford University ( Site 1024) Stanford California
United States Tampa General Hospital ( Site 1043) Tampa Florida
United States University of Toledo Medical Center ( Site 1070) Toledo Ohio
United States Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028) Torrance California
United States University of Arizona ( Site 1006) Tucson Arizona
United States The George Washington University Medical Faculty Associates ( Site 1025) Washington District of Columbia
United States Lankenau Institute for Medical Research ( Site 1089) Wynnewood Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Israel,  Italy,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24 PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). Baseline and Week 24
Secondary Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 24 The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. Baseline and Week 24
Secondary Time to First Clinical Worsening Event (TTCW) at Weeks 24 Clinical Worsening events are defined as the number of weeks from first dose date to any of the following:
Hospitalization due to a cardiopulmonary indication (a non-elective hospitalization lasting at least 24 hours in duration caused by clinical conditions directly related to Pulmonary Hypertension and/or Heart Failure)
Administration of intravenous diuretics or subcutaneous (SC) furosemide
Death (all causes)
Decrease in 6 minute walk distance (6MWD) by = 15% from baseline confirmed by 2 tests at least 4 hours, but no more than 1 week apart.
Week 24
Secondary Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Week 24 mPAP is calculated from systolic and diastolic pulmonary artery pressure measured by right heart catheterization. Baseline and Week 24
Secondary Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Week 24 PCWP is an indirect estimate of left atrial pressure measured in right heart catheterization. Baseline and Week 24
Secondary Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Week 24 TAPSE is an echocardiographic measurement of tricuspid valve annulus movement, as an indicator of right heart function. Baseline and Week 24
Secondary Change From Baseline in Right Ventricular Fractional Area Change (RVFAC) at Week 24 RVFAC is an echocardiographic measurement of percent change between right ventricular area during diastole and systole, as an indicator of right heart function. Baseline and Week 24
Secondary Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 24 LVEF is an echocardiographic measurement of percent change between left ventricular volume during diastole and systole, as an indicator of left heart function. Baseline and Week 24
Secondary Change From Baseline in Isovolumic Relaxation Time (IVRT) at Week 24 IVRT is an echocardiographic measurement of the interval between closure of the aortic valve, to onset of filling by opening of the mitral valve. It is used as an indicator of diastolic dysfunction. Baseline and Week 24
Secondary Change From Baseline in ratio of mitral inflow velocity I to mitral annular velocity'(e') (E/e' ratio) at Week 24 E/e' is a ratio measured in echocardiography as an indicator of diastolic function. Baseline and Week 24
Secondary Change From Baseline in the Ratio of the Peak Velocity Flow of the E Wave in Early Diastole to Peak Velocity Flow of the A Wave in Late Diastole (E/A Ratio) at Week 24 E/A is a ratio measured in echocardiography as an indicator of diastolic function. Baseline and Week 24
Secondary Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at Week 24 NT-proBNP is a circulating biomarker that reflects myocardial stretch. Baseline and Week 24
Secondary Change From Baseline in New York Heart Association Functional Class (NYHA FC) at Week 24 NYHA FC classifies the extent of heart failure. Baseline and Week 24
Secondary Change From Baseline in Myocardial Contraction Fraction (MCF) at Week 24 MCF is an echocardiographic measurement that determines the ratio of left ventricular stroke volume to myocardial volume and is an indicator of left ventricular systolic function. Baseline and Week 24
Secondary Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 48 The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. Baseline and Week 48
Secondary Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 48 PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization. Baseline and Week 48
Secondary Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Week 48 mPAP is calculated from systolic and diastolic pulmonary artery pressure measured by right heart catheterization. Baseline and Week 48
Secondary Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Week 48 PCWP is an indirect estimate of left atrial pressure measured in right heart catheterization. Baseline and Week 48
Secondary Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Week 48 TAPSE is an echocardiographic measurement of tricuspid valve annulus movement, as an indicator of right heart function. Baseline and Week 48
Secondary Change From Baseline in Right Ventricular Fractional Area Change (RVFAC) at Week 48 RVFAC is an echocardiographic measurement of percent change between right ventricular area during diastole and systole, as an indicator of right heart function. Baseline and Week 48
Secondary Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 48 LVEF is an echocardiographic measurement of percent change between left ventricular volume during diastole and systole, as an indicator of left heart function. Baseline and Week 48
Secondary Change From Baseline in Isovolumic Relaxation Time (IVRT) at Week 48 IVRT is an echocardiographic measurement of the interval between closure of the aortic valve, to onset of filling by opening of the mitral valve. It is used as an indicator of diastolic dysfunction. Baseline and Week 48
Secondary Change From Baseline in E/e' (Early Mitral Inflow Velocity E and Mitral Annular Early Diastolic Velocity e') Ratio at Week 48 E/e' is a ratio measured in echocardiography as an indicator of diastolic function. Baseline and Week 48
Secondary Change From Baseline in the Ratio of the Peak Velocity Flow of the E Wave in Early Diastole to Peak Velocity Flow of the A Wave in Late Diastole (E/A Ratio) at Week 48 E/A is a ratio measured in echocardiography as an indicator of diastolic function. Baseline and Week 48
Secondary Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at Week 48 NT-proBNP is a circulating biomarker that reflects myocardial stretch. Baseline and Week 48
Secondary Change From Baseline in New York Heart Association Functional Class (NYHA FC) at Week 48 NYHA FC classifies the extent of heart failure. Baseline and Week 48
Secondary Change From Baseline in Myocardial Contraction Fraction (MCF) at Week 48 MCF is an echocardiographic measurement that determines the ratio of left ventricular stroke volume to myocardial volume and is an indicator of left ventricular systolic function. Baseline and Week 48
Secondary Change From Baseline in Pulmonary Vascular Resistance (PVR) for the Placebo Crossed Over to Sotatercept Cohorts at Week 48 of the Extension Period PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization. Baseline and Week 48 of the Extension Period
Secondary Change From Baseline in the 6-minute walk distance (6MWD) for the Placebo Crossed Over to Sotatercept Cohorts at Week 48 of the Extension Period The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. Baseline and Week 48 of the Extension Period
Secondary Change From Baseline in New York Heart Association Functional Class (NYHA FC) for the Placebo Crossed Over to Sotatercept Cohorts at Week 48 of the Extension Period NYHA FC classifies the extent of heart failure. Baseline and Week 48 of the Extension Period
Secondary Change in Pulmonary Vascular Resistance (PVR) for the Placebo Crossed Over to Sotatercept Cohorts From Week 24 to Week 48 of the Extension Period PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization. From Week 24 to Week 48 of the Extension Period
Secondary Change in 6-minute Walk Distance (6MWD) for the Placebo Crossed Over to Sotatercept Cohorts From Week 24 to Week 48 of the Extension Period The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. From Week 24 to Week 48 of the Extension Period
Secondary Change in New York Heart Association Functional Class (NYHA FC) for the Placebo Crossed Over to Sotatercept Cohorts From Week 24 to Week 48 of the Extension Period NYHA FC classifies the extent of heart failure. From Week 24 to Week 48 of the Extension Period
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