Fact CheckerSign in

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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (138)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
A.O. Krankenhaus St. Josef Braunau GmbH
Coordinator of this site? Confirm its status
Braunau Am InnAustriaCompleted
Medical University of Graz
Coordinator of this site? Confirm its status
GrazAustriaCompleted
Gemeinnutzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Coordinator of this site? Confirm its status
SalzburgAustriaCompleted
Krankenhaus Nord - Klinik Floridsdorf
Coordinator of this site? Confirm its status
ViennaAustriaCompleted
Imed19-privat
Coordinator of this site? Confirm its status
ViennaAustriaCompleted
Fakultni nemocnice Brno
Coordinator of this site? Confirm its status
BrnoCzechiaCompleted
MUDr. Libor Nechvatal s.r.o.
Coordinator of this site? Confirm its status
Brno-StredCzechiaCompleted
Fakultni Nemocnice U Sv Anny V Brne
Coordinator of this site? Confirm its status
Brno-StredCzechiaCompleted
Vojenska Nemocnice Brno
Coordinator of this site? Confirm its status
Brno-ZideniceCzechiaCompleted
KardioBusak s.r.o.
Coordinator of this site? Confirm its status
LounyCzechiaCompleted
Klinika Dr. Pirka s.r.o.
Coordinator of this site? Confirm its status
Mlada Boleslav IIICzechiaCompleted
Vseobecna Fakultni Nemocnice V Praze
Coordinator of this site? Confirm its status
Prague 2CzechiaCompleted
Institute For Clinical And Experimental Medicine
Coordinator of this site? Confirm its status
Prague 4CzechiaCompleted
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha
Coordinator of this site? Confirm its status
Prague 6CzechiaCompleted
Nemocnice Slany
Coordinator of this site? Confirm its status
SlanýCzechiaCompleted
KIGE s.r.o.
Coordinator of this site? Confirm its status
ZnojmoCzechiaCompleted
SKP-Studienzentrum der kardiologischen Praxisgemeinschaft GmbH
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Klinikum Coburg GmbH
Coordinator of this site? Confirm its status
CoburgGermanyCompleted
St. Vinzenz-Hospital GmbH
Coordinator of this site? Confirm its status
CologneGermanyCompleted
Krankenhaus Dresden Friedrichstadt Staedtisches Klinikum
Coordinator of this site? Confirm its status
DresdenGermanyCompleted
Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH
Coordinator of this site? Confirm its status
DresdenGermanyCompleted
Herzzentrum Dresden GmbH Universitaetsklinik
Coordinator of this site? Confirm its status
DresdenGermanyCompleted
Katholisches Krankenhaus St Johann Nepomuk Erfurt
Coordinator of this site? Confirm its status
ErfurtGermanyCompleted
ClinPhenomics CVC GmbH
Coordinator of this site? Confirm its status
FrankfurtGermanyCompleted
University Medicine Greifswald
Coordinator of this site? Confirm its status
GreifswaldGermanyCompleted
Cardiologicum Hamburg GbR
Coordinator of this site? Confirm its status
HamburgGermanyCompleted
Medizinische Hochschule Hannover
Coordinator of this site? Confirm its status
HanoverGermanyCompleted
Heidelberg University Hospital AöR
Coordinator of this site? Confirm its status
HeidelbergGermanyCompleted
Asklepios Klinik Langen
Coordinator of this site? Confirm its status
LangenGermanyCompleted
Klinikum Leverkusen gGmbH
Coordinator of this site? Confirm its status
LeverkusenGermanyCompleted
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Coordinator of this site? Confirm its status
Ludwigshafen Am RheinGermanyCompleted
Kliniken Maria Hilf GmbH
Coordinator of this site? Confirm its status
MönchengladbachGermanyCompleted
Marienhaus Klinikum St. Elisabeth Neuwied
Coordinator of this site? Confirm its status
NeuwiedGermanyCompleted
Praxis Drs. Haggenmiller/Jeserich
Coordinator of this site? Confirm its status
NürnbergGermanyCompleted
Herz- und Gefäßzentrum
Coordinator of this site? Confirm its status
SiegenGermanyCompleted
Universitatsklinikum Wurzburg AöR
Coordinator of this site? Confirm its status
WuerzburgGermanyCompleted
Aarhus University Hospital
Coordinator of this site? Confirm its status
Aarhus NDenmarkCompleted
Rigshospitalet
Coordinator of this site? Confirm its status
Copenhagen OeDenmarkCompleted
Amager Hospital
Coordinator of this site? Confirm its status
Copenhagen SDenmarkCompleted
Sydvestjysk Sygehus
Coordinator of this site? Confirm its status
EsbjergDenmarkCompleted
Herlev Hospital
Coordinator of this site? Confirm its status
HerlevDenmarkCompleted
Nordsjaellands Hospital
Coordinator of this site? Confirm its status
HillerødDenmarkCompleted
Regionshospital Nordjylland
Coordinator of this site? Confirm its status
HjoerringDenmarkCompleted
Holbaek Sygehus
Coordinator of this site? Confirm its status
HolbækDenmarkCompleted
Hvidovre Hospital
Coordinator of this site? Confirm its status
HvidovreDenmarkCompleted
Zealand University Hospital
Coordinator of this site? Confirm its status
RoskildeDenmarkCompleted
Slagelse Hospital
Coordinator of this site? Confirm its status
SlagelseDenmarkCompleted
Odense University Hospital
Coordinator of this site? Confirm its status
SvendborgDenmarkCompleted
Complexo Hospitalario Universitario A Coruña
Coordinator of this site? Confirm its status
A CoruñaSpainCompleted
Hospital Universitari Germans Trias i Pujol
Coordinator of this site? Confirm its status
BadalonaSpainCompleted
Hospital del Mar
Coordinator of this site? Confirm its status
BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainCompleted
Bellvitge University Hospital
Coordinator of this site? Confirm its status
L'hospitalet De LlobregatSpainCompleted
Hospital Universitario Ramón y Cajal
Coordinator of this site? Confirm its status
MadridSpainCompleted
Hospital Clínico San Carlos
Coordinator of this site? Confirm its status
MadridSpainCompleted
Hospital Universitario La Paz
Coordinator of this site? Confirm its status
MadridSpainCompleted
Complexo Hospitalario Universitario De Santiago
Coordinator of this site? Confirm its status
Santiago de CompostelaSpainCompleted
Hospital Universitario Virgen De Valme
Coordinator of this site? Confirm its status
SevillaSpainCompleted
Hospital Clinico Universitario de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainCompleted
Hospices Civils de Lyon
Coordinator of this site? Confirm its status
BronFranceCompleted
Departmental Hospital Vendee
Coordinator of this site? Confirm its status
La Roche Sur Yon Cedex 9FranceCompleted
Les Hopitaux De Chartres
Coordinator of this site? Confirm its status
Le CoudrayFranceCompleted
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Le Kremlin-BicetreFranceCompleted
Centre Hospitalier Universitaire de Nice
Coordinator of this site? Confirm its status
NiceFranceCompleted
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Paris Cedex 13FranceCompleted
Centre Hospitalier Universitaire de Bordeaux
Coordinator of this site? Confirm its status
PessacFranceCompleted
CHU De Rouen
Coordinator of this site? Confirm its status
Rouen CedexFranceCompleted
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Coordinator of this site? Confirm its status
ToulonFranceCompleted
Centre Hospitalier Universitaire De Toulouse
Coordinator of this site? Confirm its status
Toulouse Cedex 9FranceCompleted
CHRU De Nancy
Coordinator of this site? Confirm its status
Vandoeuvre Les NancyFranceCompleted
University General Hospital of Alexandroupoli
Coordinator of this site? Confirm its status
AlexandroupoliGreeceCompleted
Alexandra Hospital
Coordinator of this site? Confirm its status
AthensGreeceCompleted
General Hospital of Athens "G. Gennimatas"
Coordinator of this site? Confirm its status
AthensGreeceCompleted
University General Hospital Attikon
Coordinator of this site? Confirm its status
AthensGreeceCompleted
Hippokration Hospital
Coordinator of this site? Confirm its status
AthensGreeceCompleted
University General Hospital of Ioannina
Coordinator of this site? Confirm its status
IoanninaGreeceCompleted
General University Hospital of Larissa
Coordinator of this site? Confirm its status
LarissaGreeceCompleted
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.
Coordinator of this site? Confirm its status
MaroussiGreeceCompleted
General Hospital Of Nea Ionia Konstantopouleio Patision
Coordinator of this site? Confirm its status
Nea IoniaGreeceCompleted
University General Hospital of Thessaloniki - AHEPA
Coordinator of this site? Confirm its status
ThessalonikiGreeceCompleted
Athens Medical Center S.A.
Coordinator of this site? Confirm its status
ThessalonikiGreeceCompleted
DRC Kft.
Coordinator of this site? Confirm its status
BalatonfüredHungaryCompleted
Pericardio Kft.
Coordinator of this site? Confirm its status
BékéscsabaHungaryCompleted
Gottsegen National Cardiovascular Center
Coordinator of this site? Confirm its status
BudapestHungaryCompleted
Obudai Egeszsegugyi Centrum Kft.
Coordinator of this site? Confirm its status
Budapest IIIHungaryCompleted
Semmelweis University
Coordinator of this site? Confirm its status
Budapest VIIIHungaryCompleted
Semmelweis University
Coordinator of this site? Confirm its status
Budapest XIIHungaryCompleted
Bekes Varmegyei Koezponti Korhaz
Coordinator of this site? Confirm its status
GyulaHungaryCompleted
Bacs-Kiskun Varmegyei Oktatokorhaz
Coordinator of this site? Confirm its status
KecskemétHungaryCompleted
Pest Megyei Flor Ferenc Korhaz
Coordinator of this site? Confirm its status
KistarcsaHungaryCompleted
TaNa Med Kft.
Coordinator of this site? Confirm its status
MosonmagyaróvárHungaryCompleted
Medifarma-98 Kft.
Coordinator of this site? Confirm its status
NyíregyházaHungaryCompleted
University of Pecs
Coordinator of this site? Confirm its status
PécsHungaryCompleted
Coromed Smo Kft
Coordinator of this site? Confirm its status
PécsHungaryCompleted
University of Szeged
Coordinator of this site? Confirm its status
SzegedHungaryCompleted
Complex Rendelo Med Zrt.
Coordinator of this site? Confirm its status
SzékesfehérvárHungaryCompleted
Tolna Megyei Balassa Janos Korhaz
Coordinator of this site? Confirm its status
SzekszárdHungaryCompleted
Obudai Egeszsegugyi Centrum Kft
Coordinator of this site? Confirm its status
ZalaegerszegHungaryCompleted
St Vincent's University Hospital
Coordinator of this site? Confirm its status
DublinIrelandCompleted
St James's Hospital
Coordinator of this site? Confirm its status
Dublin 8IrelandCompleted
Azienda Ospedaliera Papa Giovanni XXIII
Coordinator of this site? Confirm its status
BergamoItalyCompleted
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Coordinator of this site? Confirm its status
BolognaItalyCompleted
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Coordinator of this site? Confirm its status
BresciaItalyCompleted
University Hospital Of Ferrara
Coordinator of this site? Confirm its status
FerraraItalyCompleted
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Coordinator of this site? Confirm its status
MilanItalyCompleted
Centro Cardiologico Monzino S.p.A.
Coordinator of this site? Confirm its status
MilanItalyCompleted
ASST Grande Ospedale Metropolitano Niguarda
Coordinator of this site? Confirm its status
MilanItalyCompleted
Fondazione IRCCS Policlinico San Matteo
Coordinator of this site? Confirm its status
PaviaItalyCompleted
Hospital Santa Maria Della Misericordia
Coordinator of this site? Confirm its status
PerugiaItalyCompleted
Irccs San Raffaele Roma S.r.l.
Coordinator of this site? Confirm its status
RomeItalyCompleted
Azienda Ospealiero Universitaria Policlinico Umberto I
Coordinator of this site? Confirm its status
RomeItalyCompleted
Policlinico Le Scotte
Coordinator of this site? Confirm its status
SienaItalyCompleted
Azienda Sanitaria Universitaria Giuliano Isontina
Coordinator of this site? Confirm its status
TriesteItalyCompleted
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
Coordinator of this site? Confirm its status
TurinItalyCompleted
Azienda Sanitaria Universitaria Friuli Centrale
Coordinator of this site? Confirm its status
UdineItalyCompleted
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
Coordinator of this site? Confirm its status
BydgoszczPolandCompleted
American Heart of Poland S.A.
Coordinator of this site? Confirm its status
ChrzanówPolandCompleted
Centrum Medyczne Zdrowa J. Trebacz W. Zajdel Sp. j.
Coordinator of this site? Confirm its status
CracowPolandCompleted
Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii Lek. med. Krzysztof Cymerman
Coordinator of this site? Confirm its status
GdyniaPolandCompleted
American Heart of Poland S.A.
Coordinator of this site? Confirm its status
Kędzierzyn-KoźlePolandCompleted
Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j.
Coordinator of this site? Confirm its status
LegnicaPolandCompleted
Niepubliczny Zaklad Opieki Zdrowotnej Twoja Przychodnia Sp. z o.o.
Coordinator of this site? Confirm its status
LublinPolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach
Coordinator of this site? Confirm its status
PulawyPolandCompleted
Centrum Medyczne Medyk Sp. z o.o.
Coordinator of this site? Confirm its status
RzeszowPolandCompleted
Centrum Medyczne Dr Sudnik S.C. Wanda I Jerzy Sudnik
Coordinator of this site? Confirm its status
SokółkaPolandCompleted
Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek
Coordinator of this site? Confirm its status
TarnówPolandCompleted
Praktyka Lekarska Lidia Pawlowicz
Coordinator of this site? Confirm its status
TorunPolandCompleted
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
Coordinator of this site? Confirm its status
TorunPolandCompleted
Mcm Polimedica 2 Sp. z o.o.
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Coordinator of this site? Confirm its status
WroclawPolandCompleted
Region Dalarna
Coordinator of this site? Confirm its status
FalunSwedenCompleted
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Coordinator of this site? Confirm its status
GoteborgSwedenCompleted
Kalthus Heart & Horse AB
Coordinator of this site? Confirm its status
LundSwedenCompleted
Region Orebro lan
Coordinator of this site? Confirm its status
OrebroSwedenCompleted
Karolinska University Hospital
Coordinator of this site? Confirm its status
SolnaSwedenCompleted
Akardo AB
Coordinator of this site? Confirm its status
StockholmSwedenCompleted
Region Vasterbotten
Coordinator of this site? Confirm its status
UmeaSwedenCompleted
Region Vastmanland
Coordinator of this site? Confirm its status
VasterasSwedenCompleted

This page is information, not medical advice. Discuss any trial with your doctor.