Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00524433
Other study ID # AC-051-307
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2003
Est. completion date January 2005

Study information

Verified date July 2018
Source Idorsia Pharmaceuticals Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The randomized patients with acute heart failure will be stratified based on the presence or absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up period of 5 months for vital status.


Recruitment information / eligibility

Status Completed
Enrollment 713
Est. completion date January 2005
Est. primary completion date January 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 1.Patients 18 years of age or older. 2.Male or non-breast-feeding, non-pregnant female (only females who are post menopausal, surgically sterile or practicing a reliable method of contraception).

3.Acute heart failure (ischemic or non-ischemic). 4.Randomization within 24 hours of hospitalization (including emergency room stay) for acute heart failure.

5.Dyspnea at rest as assessed by the patient and breathing rate ³ 24/min (measured during 60 seconds).

6.At least two out of the following four criteria: · elevated BNP or N terminal pro-BNP (more than three times the upper limit of normal for the site) in patients not treated with nesiritide,· clinical evidence of pulmonary congestion/edema (e.g., rales or crackles more than a third above bases),· evidence of pulmonary congestion on chest X-ray, · left ventricular systolic dysfunction (EF < 40% or wall motion index £ 1.2 within 12 months prior to randomization).

7.Patients in need of i.v. therapy for acute heart failure and who have received at least one dose of i.v. diuretic within 24 hours prior to study drug initiation (last bolus dose must have been more than 2 hours prior to study drug initiation).

8.Written informed consent.

Exclusion Criteria:

- Criteria only for patients hemodynamically monitored:

1. Baseline cardiac index > 2.5 l/min/m2 and/or PCWP < 20 mmHg within 6 hours prior to study drug initiation.

Criteria for all patients:

2. Patients not receiving i.v. vasodilators (e.g., nitrates, nitroprusside, nesiritide) at baseline: supine systolic blood pressure < 100 mmHg. Patients receiving i.v. vasodilators (e.g., nitrates, nitroprusside, nesiritide) at baseline: supine systolic blood pressure < 120 mmHg.

3. Cardiogenic shock within the last 48 hours or evidence of volume depletion.

4. Ongoing myocardial ischaemia, coronary revascularisation procedure (PCI or CABG) during current admission or planned revascularisation.

5. ST-segment elevation myocardial infarction or administration of thrombolytic therapy.

6. Baseline creatinine = 2.5 mg/dl (221 mmol/l).

7. Baseline hemoglobin < 10 g/dl or a hematocrit < 30%.

8. Hemodialysis, ultrafiltration or peritoneal dialysis within the last 7 days.

9. Heart failure due to active myocarditis, obstructive hypertrophic cardiomyopathy, congenital heart disease, restrictive cardiomyopathy or constrictive pericarditis. Heart failure caused by valvular disease.

10. Acute heart failure associated with uncontrolled hemodynamically relevant atrial fibrillation/flutter or ventricular rhythm disturbances.

11. Acute heart failure secondary to clinical evidence of digoxin toxicity or any other drug-related toxicity.

12. Significant chronic and/or acute lung disease that might interfere with the ability to interpret the dyspnea assessments or hemodynamic measurements (e.g., severe chronic obstructive pulmonary disease or acute pneumonia).

13. Mechanical circulatory or ventilatory support. Prior CPAP use is allowed, if discontinued at least 2 hours prior to study drug initiation.

14. Acute systemic infection/sepsis or other illness with a life expectancy less than 30 days.

15. Coronary artery bypass graft, or other cardiac surgery, or major non-cardiac surgery within the last 30 days.

16. Patients who received another investigational drug within 30 days prior to randomization.

17. Re-randomization in the current study.

18. Any factors that might interfere with the study conduct or interpretation of the results such as known drug or alcohol dependence.

19. Concomitant treatment with cyclosporin A or tacrolimus.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
tezosentan
tezosentan delivered i.v. at 20 mL/h (5 mg/h) for 30 min followed by 4 mL/h (1 mg/h) for 23.5 to 71.5 h (24 to 72 h in total)
placebo


Locations

Country Name City State
Australia Concord Repatriation Hospital Concord NSW
Australia Alfred Hospital, Monash University, Central and Eastern School Prahran Victoria
Australia Queen Elizabeth Hospital Woodville SA
Czechia Faculty Hospital St. Anna Brno
Czechia Krajska Nemocnice Liberec Liberec
Czechia Klinika Kardiologie IKEM Prague
Czechia University Hospital Vinohrady (FNKV) Prague
Czechia Masaryk Hospital Usti nad Labem
Germany Universitatsklinikum der Humboldt-Universitat Berlin, Campus Charite Mitte, Med. Klinik und Poliklinik, Kardiologie Berlin
Germany Universitat Greifswald, Klinik fur Innere Medizin B Greifswald
Germany Asklepios Klinik Langen, Abteilung fur Innere Medizin Langen
Germany Universitatsklinikum Schleswig Holstein, Medizinische Klinik II, Kardiologie Lubeck
Germany Klinik u. Poliklinik F. Inn. Med. II, Univ. Klinik Regensburg Regensburg
Hungary Jahn Ferenc, Delpesti Korhaz Budapest
Hungary Polyclinic of the Hospitaler Brothers of St. John of God Budapest
Hungary University of Debrecen Debrecen
Hungary 2nd Department of Medicine & Cardiology Centre Szeged
Italy Cattedra di Cardiologia, c/o Spedali Civili Brescia
Italy Istituto Clinico Humanitas, U.O. Cardiologia Clin. E Insuff. Cardiaca Rozzano (MI)
Norway Sentralsykehuset i More og Romsdal, Dept. of Cardiology Alesund
Norway Aker University Hospital, Div. Cardiology Oslo
Norway Central Hospital in Rogaland, Cardiology Division Stavanger
United Kingdom University Department of Medicine, City Hospital Birmingham
United Kingdom Cardiology Department, Bridlington & District Hospital Bridlington
United Kingdom University of Glasgow West Glasgow
United Kingdom Dept. of Medicine & Therapeutics, University of Leicester Leicester
United States University Hospital Augusta Georgia
United States University of North Carolina Chapel Hill North Carolina
United States Duke University Medical Center Durham North Carolina
United States Elmhurst Hospital Center Elmhurst New York
United States LeBauer Cardiovascular Research Foundation Greensboro North Carolina
United States Baylor College of Medicine - Texas Medical Center Houston Texas
United States University of Texas, MD Anderson Cancer Center Houston Texas
United States Oracle Research Huntsville Alabama
United States University of Iowa Hospital and Clinics Iowa City Iowa
United States Jacksonville Center for Clinical Research Jacksonville Florida
United States USC Medical Center Los Angeles California
United States University of Miami-Jackson Memorial Hospital Miami Florida
United States Columbia Presbyterian Medical Center-Heart Failure Center New York New York
United States New York University School of Medicine New York New York
United States Medical Research Institute Slidell Louisiana
United States Baystate Medical Center-Cardiology Section Springfield Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Idorsia Pharmaceuticals Ltd.

Countries where clinical trial is conducted

United States,  Australia,  Czechia,  Germany,  Hungary,  Italy,  Norway,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of death or worsening heart failure within 7 days following study drug initiation
Secondary Patient's dyspnea assessment, measured using a visual analog scale Over first 24 hours
See also
  Status Clinical Trial Phase
Terminated NCT02151383 - Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure Phase 2
Completed NCT02135835 - A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure Phase 4
Recruiting NCT05556044 - Empagliflozin for New On-set Heart Failure Study Regardless of Ejection Fraction Phase 3
Recruiting NCT04363697 - Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68) Phase 4
Completed NCT02122640 - Evaluation of Acute Cardiogenic Dyspnoea With Thorax Echography and Pro-BNP in the Emergency Department N/A
Not yet recruiting NCT01211886 - Utility of Brain Natriuretic Peptide (BNP) in Patients With Type IV Cardio-renal Syndrome Admitted to the Intensive Care Unit (ICU) N/A
Completed NCT01193998 - Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department N/A
Not yet recruiting NCT06465498 - Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography N/A
Recruiting NCT05276219 - Optimized Treatment of Pulmonary Edema or Congestion Phase 4
Recruiting NCT05392764 - Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure Phase 3
Recruiting NCT03157219 - Manipal Heart Failure Registry (MHFR) N/A
Completed NCT06024889 - Acute Effects of Furosemide on Hemodynamics and Pulmonary Congestion in Acute Decompensated Heart Failure. Phase 1/Phase 2
Terminated NCT04174794 - Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial
Recruiting NCT05972746 - Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure N/A
Enrolling by invitation NCT02258984 - Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial N/A
Completed NCT02141607 - Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock
Completed NCT01870778 - Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF Phase 3
Recruiting NCT05986773 - Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance Phase 4
Recruiting NCT04163588 - Sequential Nephron Blockade in Acute Heart Failure Phase 3
Recruiting NCT03717636 - Early or Non-revoked in Hospital-day in Patients With Acute Heart Failure N/A