NCT05093933CompletedPhase 3
A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction
Source: EU CTIS (euclinicaltrials.eu) · Last updated 24 Feb 2025
Brief summary (registry, in English)
To evaluate the efficacy of vericiguat compared with placebo on reducing the risk of cardiovascular death or heart failure hospitalization.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 2214 (actual)
- First submitted
- 20 Jan 2023
- Start date
- 29 Oct 2021
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Heart failure
- NCT number
- NCT05093933
- EU CT number
- 2022-500881-80-00
- EudraCT number
- 2020-005941-18
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 2214
- 138 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of symptomatic carotid stenosis, transient ischemic attack (TIA), or stroke within 3 months before randomization.
- Discontinuation or dose modification of GDMT or vericiguat within 4 weeks before randomization.
- Recent history (within the last year) of drug or alcohol abuse or dependence.
- Awaiting heart transplantation, is receiving continuous IV infusion of an inotrope, or has or anticipates receiving an implanted ventricular assist device.
- Primary valvular heart disease requiring surgical procedure or intervention or has undergone a valvular surgical procedure or intervention within 3 months before randomization.
- Acute coronary syndrome, or undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 3 months before randomization.
Other illness
- Requires continuous home oxygen for severe pulmonary disease.
- Interstitial lung disease.
- History of heart transplant.
Age
- Malignancy or other noncardiac condition limiting life expectancy to <3 years.
Other
- Has SBP <100 mm Hg or symptomatic hypotension.
- Amyloidosis or sarcoidosis.
- Hypertrophic cardiomyopathy.
- Acute myocarditis or Takotsubo cardiomyopathy.
- Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia.
Who the study is looking for
- History of chronic HF [New York Heart Association (NYHA) Class II to IV] on guideline-directed medical therapy for heart failure (GDMT) with no HF hospitalization within 6 months or outpatient IV diuretic use within 3 months before randomization.
- Left ventricular ejection fraction (LVEF) of ≤40%, assessed within 12 months before randomization by any imaging method.
- Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 1 month after the last dose of study intervention.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (138)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| A.O. Krankenhaus St. Josef Braunau GmbH Coordinator of this site? Confirm its status | Braunau Am Inn | Austria | Completed |
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Completed |
| Gemeinnutzige Salzburger Landeskliniken Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Salzburg | Austria | Completed |
| Krankenhaus Nord - Klinik Floridsdorf Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Imed19-privat Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Completed |
| MUDr. Libor Nechvatal s.r.o. Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Completed |
| Fakultni Nemocnice U Sv Anny V Brne Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Completed |
| Vojenska Nemocnice Brno Coordinator of this site? Confirm its status | Brno-Zidenice | Czechia | Completed |
| KardioBusak s.r.o. Coordinator of this site? Confirm its status | Louny | Czechia | Completed |
| Klinika Dr. Pirka s.r.o. Coordinator of this site? Confirm its status | Mlada Boleslav III | Czechia | Completed |
| Vseobecna Fakultni Nemocnice V Praze Coordinator of this site? Confirm its status | Prague 2 | Czechia | Completed |
| Institute For Clinical And Experimental Medicine Coordinator of this site? Confirm its status | Prague 4 | Czechia | Completed |
| Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha Coordinator of this site? Confirm its status | Prague 6 | Czechia | Completed |
| Nemocnice Slany Coordinator of this site? Confirm its status | Slaný | Czechia | Completed |
| KIGE s.r.o. Coordinator of this site? Confirm its status | Znojmo | Czechia | Completed |
| SKP-Studienzentrum der kardiologischen Praxisgemeinschaft GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Klinikum Coburg GmbH Coordinator of this site? Confirm its status | Coburg | Germany | Completed |
| St. Vinzenz-Hospital GmbH Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| Krankenhaus Dresden Friedrichstadt Staedtisches Klinikum Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Herzzentrum Dresden GmbH Universitaetsklinik Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Katholisches Krankenhaus St Johann Nepomuk Erfurt Coordinator of this site? Confirm its status | Erfurt | Germany | Completed |
| ClinPhenomics CVC GmbH Coordinator of this site? Confirm its status | Frankfurt | Germany | Completed |
| University Medicine Greifswald Coordinator of this site? Confirm its status | Greifswald | Germany | Completed |
| Cardiologicum Hamburg GbR Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| Heidelberg University Hospital AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
| Asklepios Klinik Langen Coordinator of this site? Confirm its status | Langen | Germany | Completed |
| Klinikum Leverkusen gGmbH Coordinator of this site? Confirm its status | Leverkusen | Germany | Completed |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH Coordinator of this site? Confirm its status | Ludwigshafen Am Rhein | Germany | Completed |
| Kliniken Maria Hilf GmbH Coordinator of this site? Confirm its status | Mönchengladbach | Germany | Completed |
| Marienhaus Klinikum St. Elisabeth Neuwied Coordinator of this site? Confirm its status | Neuwied | Germany | Completed |
| Praxis Drs. Haggenmiller/Jeserich Coordinator of this site? Confirm its status | Nürnberg | Germany | Completed |
| Herz- und Gefäßzentrum Coordinator of this site? Confirm its status | Siegen | Germany | Completed |
| Universitatsklinikum Wurzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Completed |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Completed |
| Amager Hospital Coordinator of this site? Confirm its status | Copenhagen S | Denmark | Completed |
| Sydvestjysk Sygehus Coordinator of this site? Confirm its status | Esbjerg | Denmark | Completed |
| Herlev Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Completed |
| Nordsjaellands Hospital Coordinator of this site? Confirm its status | Hillerød | Denmark | Completed |
| Regionshospital Nordjylland Coordinator of this site? Confirm its status | Hjoerring | Denmark | Completed |
| Holbaek Sygehus Coordinator of this site? Confirm its status | Holbæk | Denmark | Completed |
| Hvidovre Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Completed |
| Zealand University Hospital Coordinator of this site? Confirm its status | Roskilde | Denmark | Completed |
| Slagelse Hospital Coordinator of this site? Confirm its status | Slagelse | Denmark | Completed |
| Odense University Hospital Coordinator of this site? Confirm its status | Svendborg | Denmark | Completed |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Completed |
| Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Completed |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Completed |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Completed |
| Departmental Hospital Vendee Coordinator of this site? Confirm its status | La Roche Sur Yon Cedex 9 | France | Completed |
| Les Hopitaux De Chartres Coordinator of this site? Confirm its status | Le Coudray | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Le Kremlin-Bicetre | France | Completed |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Completed |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Completed |
| CHU De Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Completed |
| Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Coordinator of this site? Confirm its status | Toulon | France | Completed |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Completed |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Completed |
| University General Hospital of Alexandroupoli Coordinator of this site? Confirm its status | Alexandroupoli | Greece | Completed |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| General Hospital of Athens "G. Gennimatas" Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Hippokration Hospital Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| University General Hospital of Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Completed |
| General University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Completed |
| Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Coordinator of this site? Confirm its status | Maroussi | Greece | Completed |
| General Hospital Of Nea Ionia Konstantopouleio Patision Coordinator of this site? Confirm its status | Nea Ionia | Greece | Completed |
| University General Hospital of Thessaloniki - AHEPA Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| DRC Kft. Coordinator of this site? Confirm its status | Balatonfüred | Hungary | Completed |
| Pericardio Kft. Coordinator of this site? Confirm its status | Békéscsaba | Hungary | Completed |
| Gottsegen National Cardiovascular Center Coordinator of this site? Confirm its status | Budapest | Hungary | Completed |
| Obudai Egeszsegugyi Centrum Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Completed |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Completed |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest XII | Hungary | Completed |
| Bekes Varmegyei Koezponti Korhaz Coordinator of this site? Confirm its status | Gyula | Hungary | Completed |
| Bacs-Kiskun Varmegyei Oktatokorhaz Coordinator of this site? Confirm its status | Kecskemét | Hungary | Completed |
| Pest Megyei Flor Ferenc Korhaz Coordinator of this site? Confirm its status | Kistarcsa | Hungary | Completed |
| TaNa Med Kft. Coordinator of this site? Confirm its status | Mosonmagyaróvár | Hungary | Completed |
| Medifarma-98 Kft. Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Completed |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Completed |
| Coromed Smo Kft Coordinator of this site? Confirm its status | Pécs | Hungary | Completed |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Completed |
| Complex Rendelo Med Zrt. Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Completed |
| Tolna Megyei Balassa Janos Korhaz Coordinator of this site? Confirm its status | Szekszárd | Hungary | Completed |
| Obudai Egeszsegugyi Centrum Kft Coordinator of this site? Confirm its status | Zalaegerszeg | Hungary | Completed |
| St Vincent's University Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Completed |
| St James's Hospital Coordinator of this site? Confirm its status | Dublin 8 | Ireland | Completed |
| Azienda Ospedaliera Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Completed |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Completed |
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Completed |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Centro Cardiologico Monzino S.p.A. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Completed |
| Hospital Santa Maria Della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Completed |
| Irccs San Raffaele Roma S.r.l. Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Azienda Ospealiero Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Policlinico Le Scotte Coordinator of this site? Confirm its status | Siena | Italy | Completed |
| Azienda Sanitaria Universitaria Giuliano Isontina Coordinator of this site? Confirm its status | Trieste | Italy | Completed |
| Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Completed |
| Azienda Sanitaria Universitaria Friuli Centrale Coordinator of this site? Confirm its status | Udine | Italy | Completed |
| Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| American Heart of Poland S.A. Coordinator of this site? Confirm its status | Chrzanów | Poland | Completed |
| Centrum Medyczne Zdrowa J. Trebacz W. Zajdel Sp. j. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii Lek. med. Krzysztof Cymerman Coordinator of this site? Confirm its status | Gdynia | Poland | Completed |
| American Heart of Poland S.A. Coordinator of this site? Confirm its status | Kędzierzyn-Koźle | Poland | Completed |
| Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j. Coordinator of this site? Confirm its status | Legnica | Poland | Completed |
| Niepubliczny Zaklad Opieki Zdrowotnej Twoja Przychodnia Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach Coordinator of this site? Confirm its status | Pulawy | Poland | Completed |
| Centrum Medyczne Medyk Sp. z o.o. Coordinator of this site? Confirm its status | Rzeszow | Poland | Completed |
| Centrum Medyczne Dr Sudnik S.C. Wanda I Jerzy Sudnik Coordinator of this site? Confirm its status | Sokółka | Poland | Completed |
| Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek Coordinator of this site? Confirm its status | Tarnów | Poland | Completed |
| Praktyka Lekarska Lidia Pawlowicz Coordinator of this site? Confirm its status | Torun | Poland | Completed |
| Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Coordinator of this site? Confirm its status | Torun | Poland | Completed |
| Mcm Polimedica 2 Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Region Dalarna Coordinator of this site? Confirm its status | Falun | Sweden | Completed |
| Sahlgrenska University Hospital-Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Completed |
| Kalthus Heart & Horse AB Coordinator of this site? Confirm its status | Lund | Sweden | Completed |
| Region Orebro lan Coordinator of this site? Confirm its status | Orebro | Sweden | Completed |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Completed |
| Akardo AB Coordinator of this site? Confirm its status | Stockholm | Sweden | Completed |
| Region Vasterbotten Coordinator of this site? Confirm its status | Umea | Sweden | Completed |
| Region Vastmanland Coordinator of this site? Confirm its status | Vasteras | Sweden | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.