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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03412201
Other study ID # CHF201701
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 11, 2018
Est. completion date October 2021

Study information

Verified date February 2021
Source Heart Initiative
Contact Maria Novosadova, MD
Phone +41614851250
Email marianovosadova@momentum-research.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

STRONG-HF is a multicenter, randomized, parallel group study designed to evaluate the efficacy and safety of up-titration of standard oral heart failure medications during hospitalization for acute heart failure. Patients admitted for acute heart failure will be randomized within 2 days before discharge to either usual care or intensification of treatment with a beta-blocker, a renin-angiotensin system blocker, and a mineralocorticoid receptor blocker ("high intensity care" arm). In the "high intensity care" arm, patients' clinical signs and symptoms of heart failure will be assessed, and routine laboratory measures and biomarkers will be measured, at frequent post-discharge visits. When these measures indicate that it is safe to do so, the doses of the oral heart failure medications will be increased to optimal levels. Patients will be followed through 180 days from randomization. Patients assigned to the usual care group will be followed by their general physician and/or cardiologist according to local medical standards. Patients who were screened but did not meet eligibility criteria will be followed for 90-day outcome. Randomized patients will be contacted at 180 days to assess outcomes.


Description:

STRONG-HF is a multicenter, randomized, parallel group study designed to evaluate the efficacy and safety of up-titration of standard of care medical therapy including beta-blockers; angiotensin converting enzyme inhibitors (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor neprolysin inhibitor (ARNi); and mineralocorticoid receptor antagonist (MRAs), on morbidity and mortality when initiated and up-titrated early during hospitalization for acute heart failure (AHF). Optimal safety conditions will allow physicians to introduce and/or continue oral HF therapies during this "vulnerable phase" in AHF patients. Patients admitted for AHF with clinical signs of congestion and elevated circulating N-terminal pro-B-type natriuretic peptide (NT-proBNP) and who are not treated with optimal doses of oral heart failure (HF) therapies within 2 days before hospital discharge for AHF and who are hemodynamically stable will be randomized in a 1:1 ratio to either usual care (named "usual care" arm) or intensification of treatment with beta-blockers, and ACEi (or ARB) or ARNi and a MRA (named "high intensity care" arm). In the latter arm, repeated assessments of clinical signs and symptoms of heart failure, routine clinical laboratory measures including potassium, sodium, and creatinine as well as NT-ProBNP will foster, encourage and ensure the safety of the optimization of oral heart failure therapies. AHF patients who were screened but did not meet inclusion criteria, including low circulating NT-proBNP at visit 2, will be followed for 90-day outcome. Randomized patients will be contacted at 180 days to assess outcomes.


Recruitment information / eligibility

Status Recruiting
Enrollment 1800
Est. completion date October 2021
Est. primary completion date October 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. Hospital admission within the 72 hours prior to Screening for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation. 2. All measures within 24 hours prior to Randomization of systolic blood pressure = 100 mmHg, and of heart rate = 60 bpm. 3. All measures within 24 hours prior to Randomization of serum potassium = 5.0 mEq/L (mmol/L). 4. Biomarker criteria for persistent congestion: 5. At Screening, NT-proBNP > 2,500 pg/mL. 6. At the time of Randomization (within 2 days prior to discharge), NT-proBNP > 1,500 pg/mL (to ensure the persistence of congestion) that has decreased by more than 10% compared to Screening (to ensure the acuity of the index episode). 7. At 1 week prior to admission, at Screening, and at Visit 2 (just prior to Randomization) either (a) <= ½ the optimal dose of ACEi/ARB/ARNi (see Table) prescribed, no beta-blocker prescribed, and <= ½ the optimal dose of MRA prescribed or (b) no ACEi/ARB/ARNi prescribed, <= ½ the optimal dose of beta-blocker prescribed, and <= ½ the optimal dose of MRA prescribed. 8. Written informed consent to participate in the study. Exclusion Criteria: 1. Age < 18 or > 85 years. 2. Clearly documented intolerance to high doses of beta-blockers. 3. Clearly documented intolerance to high doses of renin-angiotensin system (RAS) blockers (both ACEi and ARB). 4. Mechanical ventilation [not including continuous positive airway pressure (CPAP)/bilevel positive airway pressure (BIPAP)] in the 24 hours prior to Screening. 5. Significant pulmonary disease contributing substantially to the patients' dyspnea such as forced expiratory volume during the 1st second (FEV1)< 1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism. 6. Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to Screening. 7. Index Event (admission for AHF) triggered primarily by a correctable etiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response >130 beats per minute, or bradycardia with sustained ventricular arrhythmia <45 beats per minute), infection, severe anemia, acute coronary syndrome, pulmonary embolism, exacerbation of chronic obstructive pulmonary disease (COPD), planned admission for device implantation or severe non-adherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not an exclusion. 8. Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy. 9. History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device. 10. Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated. 11. Presence at Screening of any hemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation, or the presence of any hemodynamically significant obstructive lesion of the left ventricular outflow tract. 12. Active infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated white blood cells (WBC) or need for intravenous antibiotics. 13. Stroke or transient ischemic attack (TIA) within the 3 months prior to Screening. 14. Primary liver disease considered to be life threatening. 15. Renal disease or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 [as estimated by the simplified Modification of Diet in Renal Disease (MDRD) formula] at Screening or history of dialysis. 16. Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy < 6 months. 17. Prior (defined as less than 30 days from screening) or current enrollment in a congestive heart failure (CHF) trial or participation in an investigational drug or device study within the 30 days prior to screening 18. Discharge for the AHF hospitalization anticipated to be > 14 days from admission, or to a long-term care facility. Randomization must occur within 12 days following admission and within 2 days prior to anticipated discharge. 19. Inability to comply with all study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures 20. Pregnant or nursing (lactating) women.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Usual Care
Follow-up and management of heart failure medications provided by the patient's general physician and/or cardiologist according to local medical standards
High Intensity Care
Follow-up and management of heart failure medications provided by specialists at participating institutions. Doses of oral heart failure medications optimized within 2 weeks, provided clinical assessments and laboratory measures indicate that it is safe to increase doses.

Locations

Country Name City State
Argentina Chutro Srl Clinic Córdoba
Argentina Del Prado Private Clinic Córdoba
Argentina San Roque Hospital Córdoba
Argentina Rosario Cardiovascular Institute Rosario
Argentina Rosario Clinical Research Institute - Delta Rosario
Argentina Modelo Cardiology Center San Miguel De Tucumán
Argentina Diagnostic and Treatment Medical Clinic SA Santa Fe
Argentina Santa Rosa Hospital Santa Rosa
Argentina San Martin SA Clinic Venado Tuerto
Argentina Fusavim Privada SRL Clinic Villa María
Argentina Sanatorio de la Canada Villa María Cordoba
Austria Internal Med. 1, St. Josef Hospital Braunau Braunau Am Inn
Austria Clin. Dep. Internal Med 3, University Hospital St. Poelten St. Poelten
Austria Internal Med., LKH Villach Villach
Austria 1. Med. Dep, Donauspital Wien
Austria Cardiology Department at Hietzing Hospital with Neurological Center Rosenhugel Wien
Austria Dep. Of Cardiology, Medical Univ. Vienna Wien
Colombia CEQUIN Cardiomet Foundation Armenia Quindio
Colombia Santander Ophthalmological Foundation Bucaramanga Santander
Colombia Cardiovascular Diagnostic Center Cartagena Bolivar
Colombia Cardiomet Pereira Clinical Research Center Foundation Pereira Risaralda
France Auxerre Hospital Center Auxerre
France University Hospital of Beziers Béziers
France Center Hospital Regional University of Tours Trousseu Hospital Chambray-lès-Tours
France University Hospital Henri Mondor Creil
France CHU Dijon Burgundy F. Mitterand Dijon
France Hôpitaux Universitaires Saint-Louis-Lariboisière, University Paris Diderot Paris
France Center Hospital of Toulon Toulon
Hungary Buda Hospital of the Hospitaller Order of Saint John of God Budapest
Hungary Kanizsai Dorottya Hospital Nagykanizsa
Hungary St. Rafael Hospital in Zala County Zalaegerszeg
Israel Barzilay MC Ashkelon Ashkelon
Israel Asaf Harofe MC Zerifin
Mozambique Dept of Medicine Research unit, Maputo Central Hospital Maputo
Mozambique Mavalane Hospital, National Institute of Health Maputo
Nigeria Amino Kano Teaching Hospital Kano
Nigeria Murtala Muhammad Specialist Hospital Kano
Russian Federation State Budget HealthCare Institution "First City clinical hospital named after E.E. Volosevich" Arkhangel'sk
Russian Federation Regional budget Healthcare Institution "Cardiological dispensary" Ivanovo
Russian Federation Federal State Budget Educational Institution of Higher Education "Moscow State Medico-Dental University n.a. A.I. Evdokimov", under Ministry of Health of the Russian Federation Moscow
Russian Federation Federal State Budget Educational Institution of Higher Education "Moscow State University n.a. M.V. Lomonosov", independent division Medical research Educational Centre Moscow
Russian Federation Moscow City Hospital # 81, Moscow Moscow
Russian Federation Moscow State Budget Healthcare Institution City clinical Hospital 52 of Moscow Healthcare Department Moscow
Russian Federation Primary Healthcare Unit of the RF Ministry of Internal Affairs in Moscow Moscow
Russian Federation Russian National Research Medical University n.a. N.I.Pirogov based at City Clinical hospital n.a. V.M.Buyanov DZM Moscow
Russian Federation SBHI of Moscow City clinical hospital 64 of Moscow Healthcare department Moscow
Russian Federation State Budget HealthCare Institution of Moscow "City clinical hospital 15 n.a. O.M. Filatov under Department of HealthCare of Moscow" Moscow
Russian Federation State Budget HealthCare Institution of Moscow "City clinical hospital 29 n.a. N.E. Bauman under Department of HealthCare of Moscow" Moscow
Russian Federation State Budget HealthCare Institution of Mosocw "City clinical hospital 51 under Department of HealthCare of Moscow" Moscow
Russian Federation Saint-Petersburg State Budget HealthCare Institution "City hospital 38 n.a. N.A. Semashko" Pushkin
Russian Federation Municipal Government-financed Institution of Healthcare "City Emergency Hospital" of Rostov-on-Don City Rostov-on-Don
Russian Federation Federal State Budgetary Educational Institution of Higher Education "Ryazan State Medical University named after academician I.P. Pavlov" Ryazan'
Russian Federation Federal State Budget Educational Institution of Higher Education "North-West state medical university n.a. I.I. Mechnikov under the Ministry of Health of the Russian Federation" Saint Petersburg
Russian Federation Saint Petersburg State Budget Healthcare Institution Pokrovskaya City Hospital Saint Petersburg
Russian Federation Saint-Petersburg State Budget Healthcare Institution City Hospital 15 Saint Petersburg
Russian Federation State Budget Institution "Saint Petersburg state budget research institution of first aid named after I. I. Dzhanelidze" Saint Petersburg
Russian Federation State Budget HealthCare Institution of Vladimir Region "City Hospital 4 of Vladimir" Vladimir
Russian Federation State Institution of Healthcare of Yaroslavl Region "Clinical Hospital 8" Yaroslavl
Slovakia National Institute of Cardio and Vascular Diseases Bratislava
Slovakia V. Internal Clinic, LFUK and UNB Bratislava Bratislava
Slovakia Internal Department, Hospital with Polyclinic Brezno Brezno
Slovakia Internal Department, Dolnooravian Hospital of Dr. L.N.Jege Dolný Kubín
Slovakia Internal Department, Hospital with Polyclinic Lucenec Lucenec
Slovakia First Internal Clinic, Faculty Hospital with Polyclinic Nove Zamky Nové Zámky
Slovakia Department of Internal Medicine Hospital Rimavska Sobota Rimavská Sobota
Slovakia Department of Internal Medicine UVN SNP-FN Ružomberok
Slovakia Internal Department, NsP Spisska Nova Ves Spišská Nová Ves
Slovakia Internal Department Hospital Arm General L. Svobodu Svidnik Svidník
South Africa Groote Schuur Hospital Cape Town
South Africa Nelson Mandela Academic Hospital, Walter Sisulu University Mthatha
Tunisia Habib Bougatfa Hospital Bizerte
Tunisia Regional Hospital of Jendouba Jendouba
Tunisia Fattouma Bourguiba Hospital Monastir
Tunisia Hedi chaker Hospital Sfax
Tunisia Charles Nicolle Hospital Tunis
Tunisia Habib Thameur Hospital Tunis
Tunisia La Rabta Hospital Tunis
Tunisia Military Hospital Tunis

Sponsors (5)

Lead Sponsor Collaborator
Heart Initiative Hôpitaux Universitaires Saint-Louis-Lariboisière, Inserm UMRS 942, Momentum Research, Inc., Roche Diagnostics

Countries where clinical trial is conducted

Argentina,  Austria,  Colombia,  France,  Hungary,  Israel,  Mozambique,  Nigeria,  Russian Federation,  Slovakia,  South Africa,  Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Other 180-day cardiovascular death Cumulative risk of death due to cardiovascular cause at 180 days 180 days
Other 90-day cardiovascular death Cumulative risk of death due to cardiovascular cause at 90 days 90 days
Other 90-day all-cause mortality Cumulative risk of death at 90 days 90 days
Other 180-day heart failure readmission Cumulative risk of readmission for heart failure at 180 days 180 days
Other 90-day heart failure readmission Cumulative risk of readmission for heart failure at 90 days 90 days
Other Finkelstein-Schoenfeld hierarchical composite Hierarchical composite endpoint comprising death, heart failure readmissions, and EQ-VAS analyzed using Finkelstein-Schoenfeld methodology 90 days
Other Change in NT-proBNP Change from baseline to 90 days in NT-proBNP on the log scale 90 days
Other Change in weight Change from baseline to 90 days in weight in kg 90 days
Other Changes in signs and symptoms of congestion: NYHA class Changes from baseline to 90 days in New York Heart Association (NYHA) class which ranges from 1 to 4 with a higher class representing a worse outcome 90 days
Other Changes in signs and symptoms of congestion: orthopnea Changes from baseline to 90 days in orthopnea rated on a scale from 0 to 3 with a higher score representing a worse outcome 90 days
Other Changes in signs and symptoms of congestion: peripheral edema Changes from baseline to 90 days in peripheral edema rated on a scale from 0 to 3 with a higher score representing a worse outcome 90 days
Other Changes in signs and symptoms of congestion: rales Changes from baseline to 90 days in rales rated on a scale from 0 to 3 with a higher score representing a worse outcome 90 days
Other Changes in signs and symptoms of congestion: JVP Changes from baseline to 90 days in jugular venous pulse (JVP) rated on a scale from 1 to 4 with a higher score representing a worse outcome 90 days
Primary 180-day all-cause mortality or heart failure readmission Cumulative risk of either readmission for heart failure or death at 180 days 180 days
Secondary Change in quality of life Change from baseline to 90 days in quality of life as measured using the EQ-5D visual analogue scale (VAS) which ranges from 0 to 100 with a higher score representing a better outcome. "EQ-5D" is the official name of a quality of life instrument developed by EuroQol. 90 days
Secondary 180-day all-cause mortality Cumulative risk of death at 180 days 180 days
Secondary 90-day all-cause mortality or heart failure readmission Cumulative risk of either readmission for heart failure or death at 90 days 90 days
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