NCT03412201

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started May 2018

Typical duration for not_applicable heart-failure

Geographic Reach
12 countries

78 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

May 11, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

3.4 years

First QC Date

January 12, 2018

Last Update Submit

February 9, 2021

Conditions

Keywords

Disease managementMedication therapy managementBiomarkers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in quality of life

    90 days

  • 180-day all-cause mortality

    180 days

  • 90-day all-cause mortality or heart failure readmission

    90 days

Other Outcomes (13)

  • 180-day cardiovascular death

    180 days

  • 90-day cardiovascular death

    90 days

  • 90-day all-cause mortality

    90 days

  • +10 more other outcomes

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Follow-up and management of heart failure medications provided by the patient's general physician and/or cardiologist according to local medical standards

Other: Usual Care

High Intensity Care

EXPERIMENTAL

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.

Other: High Intensity Care

Interventions

Follow-up and management of heart failure medications provided by the patient's general physician and/or cardiologist according to local medical standards

Usual 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.

High Intensity Care

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (78)

Sanatorio de la Canada

Villa María, Córdoba Province, X5900JKA, Argentina

RECRUITING

Chutro Srl Clinic

Córdoba, Argentina

RECRUITING

Del Prado Private Clinic

Córdoba, Argentina

RECRUITING

San Roque Hospital

Córdoba, Argentina

RECRUITING

Rosario Cardiovascular Institute

Rosario, Argentina

RECRUITING

Rosario Clinical Research Institute - Delta

Rosario, Argentina

RECRUITING

Modelo Cardiology Center

San Miguel de Tucumán, Argentina

RECRUITING

Diagnostic and Treatment Medical Clinic SA

Santa Fe, Argentina

RECRUITING

Santa Rosa Hospital

Santa Rosa, Argentina

RECRUITING

San Martin SA Clinic

Venado Tuerto, Argentina

RECRUITING

Fusavim Privada SRL Clinic

Villa María, Argentina

RECRUITING

Internal Med. 1, St. Josef Hospital Braunau

Braunau am Inn, Austria

TERMINATED

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

Sankt Pölten, Austria

TERMINATED

1. Med. Dep, Donauspital

Vienna, Austria

WITHDRAWN

Cardiology Department at Hietzing Hospital with Neurological Center Rosenhugel

Vienna, Austria

WITHDRAWN

Dep. Of Cardiology, Medical Univ. Vienna

Vienna, Austria

WITHDRAWN

Internal Med., LKH Villach

Villach, Austria

WITHDRAWN

Cardiovascular Diagnostic Center

Cartagena, Departamento de Bolívar, 130001, Colombia

RECRUITING

CEQUIN Cardiomet Foundation

Armenia, Quindío Department, 630004, Colombia

RECRUITING

Cardiomet Pereira Clinical Research Center Foundation

Pereira, Risaralda Department, 660003, Colombia

RECRUITING

Santander Ophthalmological Foundation

Bucaramanga, Santander Department, 681004, Colombia

RECRUITING

Auxerre Hospital Center

Auxerre, France

WITHDRAWN

University Hospital of Beziers

Béziers, France

WITHDRAWN

Center Hospital Regional University of Tours Trousseu Hospital

Chambray-lès-Tours, France

WITHDRAWN

University Hospital Henri Mondor

Creil, France

WITHDRAWN

CHU Dijon Burgundy F. Mitterand

Dijon, France

WITHDRAWN

Hôpitaux Universitaires Saint-Louis-Lariboisière, University Paris Diderot

Paris, France

WITHDRAWN

Center Hospital of Toulon

Toulon, France

WITHDRAWN

Buda Hospital of the Hospitaller Order of Saint John of God

Budapest, Hungary

TERMINATED

Kanizsai Dorottya Hospital

Nagykanizsa, Hungary

TERMINATED

St. Rafael Hospital in Zala County

Zalaegerszeg, Hungary

WITHDRAWN

Barzilay MC Ashkelon

Ashkelon, Israel

TERMINATED

Asaf Harofe MC

Ẕerifin, Israel

WITHDRAWN

Dept of Medicine Research unit, Maputo Central Hospital

Maputo, Mozambique

RECRUITING

Mavalane Hospital, National Institute of Health

Maputo, Mozambique

TERMINATED

Amino Kano Teaching Hospital

Kano, Nigeria

RECRUITING

Murtala Muhammad Specialist Hospital

Kano, Nigeria

RECRUITING

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

Arkhangelsk, Russia

RECRUITING

Regional budget Healthcare Institution "Cardiological dispensary"

Ivanovo, Russia

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, Russia

RECRUITING

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

Moscow, Russia

TERMINATED

Moscow City Hospital # 81, Moscow

Moscow, Russia

RECRUITING

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

Moscow, Russia

RECRUITING

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

Moscow, Russia

TERMINATED

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

Moscow, Russia

RECRUITING

SBHI of Moscow City clinical hospital 64 of Moscow Healthcare department

Moscow, Russia

RECRUITING

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

Moscow, Russia

RECRUITING

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

Moscow, Russia

RECRUITING

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

Moscow, Russia

RECRUITING

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

Pushkin, Russia

TERMINATED

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

Rostov-on-Don, Russia

RECRUITING

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

Ryazan, Russia

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, Russia

TERMINATED

Saint Petersburg State Budget Healthcare Institution Pokrovskaya City Hospital

Saint Petersburg, Russia

TERMINATED

Saint-Petersburg State Budget Healthcare Institution City Hospital 15

Saint Petersburg, Russia

RECRUITING

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

Saint Petersburg, Russia

RECRUITING

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

Vladimir, Russia

RECRUITING

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

Yaroslavl, Russia

TERMINATED

National Institute of Cardio and Vascular Diseases

Bratislava, Slovakia

TERMINATED

V. Internal Clinic, LFUK and UNB Bratislava

Bratislava, Slovakia

TERMINATED

Internal Department, Hospital with Polyclinic Brezno

Brezno, Slovakia

TERMINATED

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

Dolný Kubín, Slovakia

TERMINATED

Internal Department, Hospital with Polyclinic Lucenec

Lučenec, Slovakia

TERMINATED

First Internal Clinic, Faculty Hospital with Polyclinic Nove Zamky

Nové Zámky, Slovakia

TERMINATED

Department of Internal Medicine Hospital Rimavska Sobota

Rimavská Sobota, Slovakia

TERMINATED

Department of Internal Medicine UVN SNP-FN

Ružomberok, Slovakia

TERMINATED

Internal Department, NsP Spisska Nova Ves

Spišská Nová Ves, Slovakia

TERMINATED

Internal Department Hospital Arm General L. Svobodu Svidnik

Svidník, Slovakia

TERMINATED

Groote Schuur Hospital

Cape Town, South Africa

TERMINATED

Nelson Mandela Academic Hospital, Walter Sisulu University

Mthatha, South Africa

TERMINATED

Habib Bougatfa Hospital

Bizerte, Tunisia

TERMINATED

Regional Hospital of Jendouba

Jendouba, Tunisia

TERMINATED

Fattouma Bourguiba Hospital

Monastir, Tunisia

TERMINATED

Hedi chaker Hospital

Sfax, Tunisia

TERMINATED

Charles Nicolle Hospital

Tunis, Tunisia

WITHDRAWN

Habib Thameur Hospital

Tunis, Tunisia

TERMINATED

La Rabta Hospital

Tunis, Tunisia

TERMINATED

Military Hospital

Tunis, Tunisia

WITHDRAWN

Related Publications (13)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Alexandre Mebazaa, MD PhD FESC

    Inserm UMRS 942; Hôpitaux Universitaires Saint-Louis-Lariboisière, University Paris Diderot

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: multicenter, randomized, parallel group study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 26, 2018

Study Start

May 11, 2018

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

February 12, 2021

Record last verified: 2021-02

Locations