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AzTrials

Heart FailureSTRONG-HFNCT03412201

Safety, Tolerability and Efficacy of Rapid Optimization, Helped by NT-proBNP testinG, of Heart Failure Therapies

A study testing High Intensity Care in people with Heart Failure, run by Heart Initiative at 78 sites in 12 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Heart Failure
What is being tested?
High Intensity Care
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,800 participants
Where
78 sitesin 12 countries
Study dates
11 May 2018to Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • All measures within 24 hours prior to Randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
  • All measures within 24 hours prior to Randomization of serum potassium ≤ 5.0 mEq/L (mmol/L).
  • Biomarker criteria for persistent congestion:
  • At Screening, NT-proBNP > 2,500 pg/mL.
  • 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).
  • 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.
  • Written informed consent to participate in the study.

Who cannot join

  • Age < 18 or > 85 years.
  • Clearly documented intolerance to high doses of beta-blockers.
  • Clearly documented intolerance to high doses of renin-angiotensin system (RAS) blockers (both ACEi and ARB).
  • Mechanical ventilation [not including continuous positive airway pressure (CPAP)/bilevel positive airway pressure (BIPAP)] in the 24 hours prior to Screening.
  • 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.
  • 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.
Show all 20Show fewer
  • 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.
  • Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.
  • History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
  • Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.
  • 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.
  • 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.
  • Stroke or transient ischemic attack (TIA) within the 3 months prior to Screening.
  • Primary liver disease considered to be life threatening.
  • 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.
  • Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy < 6 months.
  • 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
  • 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.
  • 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
  • Pregnant or nursing (lactating) women.

Trial locations and contacts

78 sites in 12 countries.

Maria Novosadova, MD contact

+41614851250

marianovosadova@momentum-research.com

78 sites in 12 countries

Russia21 sites, 15 recruiting

  • State Budget HealthCare Institution "First City clinical hospital named after E.E. Volosevich"

    Arkhangelsk

    Recruiting

  • Regional budget Healthcare Institution "Cardiological dispensary"

    Ivanovo

    Recruiting

  • 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

    Recruiting

  • Federal State Budget Educational Institution of Higher Education "Moscow State University n.a. M.V. Lomonosov", independent division Medical research Educational Centre

    Moscow

    Terminated

  • Moscow City Hospital # 81, Moscow

    Moscow

    Recruiting

  • Moscow State Budget Healthcare Institution City clinical Hospital 52 of Moscow Healthcare Department

    Moscow

    Recruiting

  • Primary Healthcare Unit of the RF Ministry of Internal Affairs in Moscow

    Moscow

    Terminated

  • Russian National Research Medical University n.a. N.I.Pirogov based at City Clinical hospital n.a. V.M.Buyanov DZM

    Moscow

    Recruiting

  • SBHI of Moscow City clinical hospital 64 of Moscow Healthcare department

    Moscow

    Recruiting

  • State Budget HealthCare Institution of Moscow "City clinical hospital 15 n.a. O.M. Filatov under Department of HealthCare of Moscow"

    Moscow

    Recruiting

  • State Budget HealthCare Institution of Moscow "City clinical hospital 29 n.a. N.E. Bauman under Department of HealthCare of Moscow"

    Moscow

    Recruiting

  • State Budget HealthCare Institution of Mosocw "City clinical hospital 51 under Department of HealthCare of Moscow"

    Moscow

    Recruiting

  • Saint-Petersburg State Budget HealthCare Institution "City hospital 38 n.a. N.A. Semashko"

    Pushkin

    Terminated

  • Municipal Government-financed Institution of Healthcare "City Emergency Hospital" of Rostov-on-Don City

    Rostov-on-Don

    Recruiting

  • Federal State Budgetary Educational Institution of Higher Education "Ryazan State Medical University named after academician I.P. Pavlov"

    Ryazan

    Recruiting

  • 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

    Terminated

  • Saint Petersburg State Budget Healthcare Institution Pokrovskaya City Hospital

    Saint Petersburg

    Terminated

  • Saint-Petersburg State Budget Healthcare Institution City Hospital 15

    Saint Petersburg

    Recruiting

  • State Budget Institution "Saint Petersburg state budget research institution of first aid named after I. I. Dzhanelidze"

    Saint Petersburg

    Recruiting

  • State Budget HealthCare Institution of Vladimir Region "City Hospital 4 of Vladimir"

    Vladimir

    Recruiting

  • State Institution of Healthcare of Yaroslavl Region "Clinical Hospital 8"

    Yaroslavl

    Terminated

Other trials in Russia

Argentina11 sites, 11 recruiting

  • Chutro Srl Clinic

    Córdoba

    Recruiting

  • Del Prado Private Clinic

    Córdoba

    Recruiting

  • San Roque Hospital

    Córdoba

    Recruiting

  • Rosario Cardiovascular Institute

    Rosario

    Recruiting

  • Rosario Clinical Research Institute - Delta

    Rosario

    Recruiting

  • Modelo Cardiology Center

    San Miguel de Tucumán

    Recruiting

  • Diagnostic and Treatment Medical Clinic SA

    Santa Fe

    Miguel Angel Hominal

    Recruiting

  • Santa Rosa Hospital

    Santa Rosa

    Recruiting

  • San Martin SA Clinic

    Venado Tuerto

    Recruiting

  • Sanatorio de la Canada

    Villa María, Córdoba Province, X5900JKA

    Maria Novosadova, MD, 1614851250 ext. 4, marianovosadova@momentum-research.com

    Recruiting

  • Fusavim Privada SRL Clinic

    Villa María

    Recruiting

Other trials in Argentina

Slovakia10 sites

  • National Institute of Cardio and Vascular Diseases

    Bratislava

    Terminated

  • V. Internal Clinic, LFUK and UNB Bratislava

    Bratislava

    Terminated

  • Internal Department, Hospital with Polyclinic Brezno

    Brezno

    Terminated

  • Internal Department, Dolnooravian Hospital of Dr. L.N.Jege

    Dolný Kubín

    Terminated

  • Internal Department, Hospital with Polyclinic Lucenec

    Lučenec

    Terminated

  • First Internal Clinic, Faculty Hospital with Polyclinic Nove Zamky

    Nové Zámky

    Terminated

  • Department of Internal Medicine Hospital Rimavska Sobota

    Rimavská Sobota

    Terminated

  • Department of Internal Medicine UVN SNP-FN

    Ružomberok

    Terminated

  • Internal Department, NsP Spisska Nova Ves

    Spišská Nová Ves

    Terminated

  • Internal Department Hospital Arm General L. Svobodu Svidnik

    Svidník

    Terminated

Other trials in Slovakia

Tunisia8 sites

  • Habib Bougatfa Hospital

    Bizerte

    Terminated

  • Regional Hospital of Jendouba

    Jendouba

    Terminated

  • Fattouma Bourguiba Hospital

    Monastir

    Terminated

  • Hedi chaker Hospital

    Sfax

    Terminated

  • Charles Nicolle Hospital

    Tunis

    Withdrawn

  • Habib Thameur Hospital

    Tunis

    Terminated

  • La Rabta Hospital

    Tunis

    Terminated

  • Military Hospital

    Tunis

    Withdrawn

Other trials in Tunisia

France7 sites

  • Auxerre Hospital Center

    Auxerre

    Withdrawn

  • University Hospital of Beziers

    Béziers

    Withdrawn

  • Center Hospital Regional University of Tours Trousseu Hospital

    Chambray-lès-Tours

    Withdrawn

  • University Hospital Henri Mondor

    Creil

    Withdrawn

  • CHU Dijon Burgundy F. Mitterand

    Dijon

    Withdrawn

  • Hôpitaux Universitaires Saint-Louis-Lariboisière, University Paris Diderot

    Paris

    Withdrawn

  • Center Hospital of Toulon

    Toulon

    Withdrawn

Other trials in France

Austria6 sites

  • Internal Med. 1, St. Josef Hospital Braunau

    Braunau am Inn

    Terminated

  • Clin. Dep. Internal Med 3, University Hospital St. Poelten

    Sankt Pölten

    Terminated

  • 1. Med. Dep, Donauspital

    Vienna

    Withdrawn

  • Cardiology Department at Hietzing Hospital with Neurological Center Rosenhugel

    Vienna

    Withdrawn

  • Dep. Of Cardiology, Medical Univ. Vienna

    Vienna

    Withdrawn

  • Internal Med., LKH Villach

    Villach

    Withdrawn

Other trials in Austria

Colombia4 sites, 4 recruiting

  • CEQUIN Cardiomet Foundation

    Armenia, Quindío Department, 630004

    Gregorio Sánchez Vallejo, 3104527096 ext. 57

    Recruiting

  • Santander Ophthalmological Foundation

    Bucaramanga, Santander Department, 681004

    Juan Diego Higuera Cobos, 3162791839 ext. 57

    Recruiting

  • Cardiovascular Diagnostic Center

    Cartagena, Departamento de Bolívar, 130001

    Fernando Gabriel Manzur Jattín, 3157315055 ext. 57

    Recruiting

  • Cardiomet Pereira Clinical Research Center Foundation

    Pereira, Risaralda Department, 660003

    Luis Hernando Garcia Ortiz, 3116111 ext. 57

    Recruiting

Other trials in Colombia

Hungary3 sites

  • Buda Hospital of the Hospitaller Order of Saint John of God

    Budapest

    Terminated

  • Kanizsai Dorottya Hospital

    Nagykanizsa

    Terminated

  • St. Rafael Hospital in Zala County

    Zalaegerszeg

    Withdrawn

Other trials in Hungary

Israel2 sites

  • Barzilay MC Ashkelon

    Ashkelon

    Terminated

  • Asaf Harofe MC

    Tsrifin

    Withdrawn

Other trials in Israel

Mozambique2 sites, 1 recruiting

  • Dept of Medicine Research unit, Maputo Central Hospital

    Maputo

    Recruiting

  • Mavalane Hospital, National Institute of Health

    Maputo

    Terminated

Other trials in Mozambique

Nigeria2 sites, 2 recruiting

  • Amino Kano Teaching Hospital

    Kano

    Recruiting

  • Murtala Muhammad Specialist Hospital

    Kano

    Recruiting

Other trials in Nigeria

South Africa2 sites

  • Groote Schuur Hospital

    Cape Town

    Terminated

  • Nelson Mandela Academic Hospital, Walter Sisulu University

    Mthatha

    Terminated

Other trials in South Africa

About this study

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.

Read the detailed 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.

Conditions
Heart Failure
Being tested
Usual Care, High Intensity Care
Keywords
Disease management, Medication therapy management, Biomarkers
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual CareOther

    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 CareOther

    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.

Study groups in NCT03412201
Study groupRoleWhat they receive
Usual CareActive comparatorFollow-up and management of heart failure medications provided by the patient's general physician and/or cardiologist according to local medical standards
Receives: Other: Usual Care
High Intensity CareExperimentalFollow-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.
Receives: Other: High Intensity Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 180-day all-cause mortality or heart failure readmission

    Cumulative risk of either readmission for heart failure or death at 180 days

    Measured: 180 days

Secondary outcomes (3)

  1. 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.

    Measured: 90 days

  2. 180-day all-cause mortality

    Cumulative risk of death at 180 days

    Measured: 180 days

  3. 90-day all-cause mortality or heart failure readmission

    Cumulative risk of either readmission for heart failure or death at 90 days

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2018
  2. Study start11 May 2018
  3. Primary completionOct 2021 (estimated)
  4. Study completionOct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
multicenter, randomized, parallel group study
Masking
None (open label)
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03412201
Sponsor's protocol ID
CHF201701
Acronym
STRONG-HF
Status last verified
Feb 2021
First submitted
12 Jan 2018
Last updated
12 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhang X, Davison B, Adamo M, Arrigo M, Biegus J, Chioncel O, Cohen Solal A, Cotter G, Edwards C, Kimmoun A, Lam CSP, Mebazaa A, Metra M, Novosadova M, Pang PS, Sliwa K, Takagi K, Voors AA, Ezekowitz JA. Guideline-Directed Medical Therapy Use in the STRONG-HF Trial. Circ Heart Fail. 2025 Sep;18(9):e012716. doi: 10.1161/CIRCHEARTFAILURE.124.012716. Epub 2025 Jul 3.

    PubMed 40605744

  • Myhre PL, Grupper A, Mebazaa A, Davison B, Edwards C, Takagi K, Adamo M, Arrigo M, Barros M, Biegus J, Celutkiene J, Cerlinskaite-Bajore K, Chioncel O, Cohen-Solal A, Damasceno A, Deniau B, Diaz R, Filippatos G, Gayat E, Kimmoun A, Ter Maaten JM, Metra M, Novosadova M, Pagnesi M, Pang PS, Ponikowski P, Saidu H, Sliwa K, Tomasoni D, Voors A, Cotter G, Lam CSP. Changes in Liver Function Tests, Congestion, and Prognosis After Acute Heart Failure: The STRONG-HF Trial. JACC Adv. 2025 Mar;4(3):101607. doi: 10.1016/j.jacadv.2025.101607. Epub 2025 Feb 21.

    PubMed 39983609

  • Farmakis D, Davison B, Fountoulaki K, Liori S, Chioncel O, Metra M, Celutkiene J, Cohen-Solal A, Damasceno A, Diaz R, Edwards C, Gayat E, Novosadova M, Bistola V, Pang PS, Ponikowski P, Saidu H, Sliwa K, Takagi K, Voors AA, Mebazaa A, Cotter G, Filippatos G. Rapid Uptitration of Guideline-Directed Medical Therapies in Acute Heart Failure With and Without Atrial Fibrillation. JACC Heart Fail. 2024 Nov;12(11):1845-1858. doi: 10.1016/j.jchf.2024.06.010. Epub 2024 Aug 14.

    PubMed 39152986

  • Arrigo M, Davison B, Edwards C, Adamo M, Ambrosy AP, Barros M, Biegus J, Celutkiene J, Cerlinskaite-Bajore K, Chioncel O, Cohen-Solal A, Damasceno A, Diaz R, Filippatos G, Gayat E, Kimmoun A, Lam CSP, Metra M, Novosadova M, Pagnesi M, Pang PS, Ponikowski P, Saidu H, Sliwa K, Takagi K, Ter Maaten JM, Tomasoni D, Voors AA, Cotter G, Mebazaa A. Characteristics, treatment, and outcomes of early vs. late enrollees of the STRONG-HF trial. Am Heart J. 2024 Aug;274:119-129. doi: 10.1016/j.ahj.2024.04.019. Epub 2024 May 12.

    PubMed 38740532

  • Ambrosy AP, Chang AJ, Davison B, Voors A, Cohen-Solal A, Damasceno A, Kimmoun A, Lam CSP, Edwards C, Tomasoni D, Gayat E, Filippatos G, Saidu H, Biegus J, Celutkiene J, Ter Maaten JM, Cerlinskaite-Bajore K, Sliwa K, Takagi K, Metra M, Novosadova M, Barros M, Adamo M, Pagnesi M, Arrigo M, Chioncel O, Diaz R, Pang PS, Ponikowski P, Cotter G, Mebazaa A. Titration of Medications After Acute Heart Failure Is Safe, Tolerated, and Effective Regardless of Risk. JACC Heart Fail. 2024 Sep;12(9):1566-1582. doi: 10.1016/j.jchf.2024.04.017. Epub 2024 May 12.

    PubMed 38739123

  • Celutkiene J, Cerlinskaite-Bajore K, Cotter G, Edwards C, Adamo M, Arrigo M, Barros M, Biegus J, Chioncel O, Cohen-Solal A, Damasceno A, Diaz R, Filippatos G, Gayat E, Kimmoun A, Leopold V, Metra M, Novosadova M, Pagnesi M, Pang PS, Ponikowski P, Saidu H, Sliwa K, Takagi K, Ter Maaten JM, Tomasoni D, Lam CSP, Voors AA, Mebazaa A, Davison B. Impact of Rapid Up-Titration of Guideline-Directed Medical Therapies on Quality of Life: Insights From the STRONG-HF Trial. Circ Heart Fail. 2024 Apr;17(4):e011221. doi: 10.1161/CIRCHEARTFAILURE.123.011221. Epub 2024 Mar 6.

    PubMed 38445950

  • Cotter G, Deniau B, Davison B, Edwards C, Adamo M, Arrigo M, Barros M, Biegus J, Celutkiene J, Cerlinskaite-Bajore K, Chioncel O, Cohen-Solal A, Damasceno A, Diaz R, Filippatos G, Gayat E, Kimmoun A, Lam CSP, Metra M, Novosadova M, Pang PS, Pagnesi M, Ponikowski P, Saidu H, Sliwa K, Takagi K, Ter Maaten JM, Tomasoni D, Voors A, Mebazaa A. Optimization of Evidence-Based Heart Failure Medications After an Acute Heart Failure Admission: A Secondary Analysis of the STRONG-HF Randomized Clinical Trial. JAMA Cardiol. 2024 Feb 1;9(2):114-124. doi: 10.1001/jamacardio.2023.4553.

    PubMed 38150260

  • Pagnesi M, Metra M, Cohen-Solal A, Edwards C, Adamo M, Tomasoni D, Lam CSP, Chioncel O, Diaz R, Filippatos G, Ponikowski P, Sliwa K, Voors AA, Kimmoun A, Novosadova M, Takagi K, Barros M, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G, Mebazaa A, Davison B. Uptitrating Treatment After Heart Failure Hospitalization Across the Spectrum of Left Ventricular Ejection Fraction. J Am Coll Cardiol. 2023 Jun 6;81(22):2131-2144. doi: 10.1016/j.jacc.2023.03.426.

    PubMed 37257948

  • Adamo M, Pagnesi M, Mebazaa A, Davison B, Edwards C, Tomasoni D, Arrigo M, Barros M, Biegus J, Celutkiene J, Cerlinskaite-Bajore K, Chioncel O, Cohen-Solal A, Damasceno A, Diaz R, Filippatos G, Gayat E, Kimmoun A, Lam CSP, Novosadova M, Pang PS, Ponikowski P, Saidu H, Sliwa K, Takagi K, Ter Maaten JM, Voors A, Cotter G, Metra M. NT-proBNP and high intensity care for acute heart failure: the STRONG-HF trial. Eur Heart J. 2023 Aug 14;44(31):2947-2962. doi: 10.1093/eurheartj/ehad335.

    PubMed 37217188

  • Cerlinskaite-Bajore K, Lam CSP, Sliwa K, Adamo M, Ter Maaten JM, Leopold V, Mebazaa A, Davison B, Edwards C, Arrigo M, Barros M, Biegus J, Chioncel O, Cohen-Solal A, Damasceno A, Diaz R, Filippatos G, Gayat E, Kimmoun A, Metra M, Novosadova M, Pagnesi M, Pang PS, Ponikowski P, Saidu H, Takagi K, Tomasoni D, Voors AA, Cotter G, Celutkiene J. Sex-specific analysis of the rapid up-titration of guideline-directed medical therapies after a hospitalization for acute heart failure: Insights from the STRONG-HF trial. Eur J Heart Fail. 2023 Jul;25(7):1156-1165. doi: 10.1002/ejhf.2882. Epub 2023 Jun 1.

    PubMed 37191154

  • Mebazaa A, Davison B, Chioncel O, Cohen-Solal A, Diaz R, Filippatos G, Metra M, Ponikowski P, Sliwa K, Voors AA, Edwards C, Novosadova M, Takagi K, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 Dec 3;400(10367):1938-1952. doi: 10.1016/S0140-6736(22)02076-1. Epub 2022 Nov 7.

    PubMed 36356631

  • Cotter G, Davison B, Metra M, Sliwa K, Voors AA, Addad F, Celutkiene J, Chioncel O, Cohen Solal A, Diaz R, Damasceno A, Duengen HD, Filippatos G, Goncalvesova E, Merai I, Ponikowski P, Privalov D, Sani MU, Takagi K, Shogenov Z, Saidu H, Mebazaa A. Amended STRONG-HF study design. Eur J Heart Fail. 2021 Nov;23(11):1981-1982. doi: 10.1002/ejhf.2348. Epub 2021 Oct 4. No abstract available.

    PubMed 34529313

  • Kimmoun A, Cotter G, Davison B, Takagi K, Addad F, Celutkiene J, Chioncel O, Solal AC, Diaz R, Damasceno A, Duengen HD, Filippatos G, Goncalvesova E, Merai I, Metra M, Ponikowski P, Privalov D, Sliwa K, Sani MU, Voors AA, Shogenov Z, Mebazaa A. Safety, Tolerability and efficacy of Rapid Optimization, helped by NT-proBNP and GDF-15, of Heart Failure therapies (STRONG-HF): rationale and design for a multicentre, randomized, parallel-group study. Eur J Heart Fail. 2019 Nov;21(11):1459-1467. doi: 10.1002/ejhf.1575. Epub 2019 Aug 19.

    PubMed 31423712

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Care in people with Heart Failure, run by Heart Initiative at 78 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in Russia, Argentina, Slovakia, Tunisia, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maria Novosadova, MD (+41614851250, marianovosadova@momentum-research.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

180-day all-cause mortality or heart failure readmission (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03412201, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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