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Clinical Trials List

Protocol NumberMK-1242-035
NCT Number(ClinicalTrials.gov Identfier)NCT05093933
Completed

2021-12-10 - 2025-10-31

Phase III

Recruiting6

ICD-10I50.20

Unspecified systolic (congestive) heart failure

ICD-10I50.21

Acute systolic (congestive) heart failure

ICD-10I50.22

Chronic systolic (congestive) heart failure

ICD-10I50.23

Acute on chronic systolic (congestive) heart failure

ICD-10I50.30

Unspecified diastolic (congestive) heart failure

ICD-10I50.31

Acute diastolic (congestive) heart failure

ICD-10I50.32

Chronic diastolic (congestive) heart failure

ICD-10I50.33

Acute on chronic diastolic (congestive) heart failure

ICD-10I50.40

Unspecified combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.41

Acute combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.42

Chronic combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.43

Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.9

Heart failure, unspecified

ICD-9428.0

Congestive heart failure

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

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    Merck Sharp & Dohme LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator JIN–LONG HUANG Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-Chang Hsieh Division of Cardiovascular Diseases

Co-Principal Investigator

  • 陳東藝 Division of Cardiovascular Diseases
  • 陳俊吉 Division of Cardiovascular Diseases
  • 何明昀 Division of Cardiovascular Diseases
  • 葉日凱 Division of Cardiovascular Diseases
  • 謝明哲 Division of Cardiovascular Diseases
  • 彭健榮 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Taipei Veterans General Hospital

Taiwan National PI

Chern-En Chiang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 夏建勳 Division of Cardiovascular Diseases

Co-Principal Investigator

  • 王聖云 Division of Cardiovascular Diseases
  • 黃宏凱 Division of Cardiovascular Diseases
  • 張惟智 Division of Cardiovascular Diseases
  • 簡思齊 Division of Cardiovascular Diseases
  • 楊秉忠 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉銘恩 Division of Cardiovascular Diseases

Co-Principal Investigator

  • 劉俞旻 Division of Cardiovascular Diseases
  • 賴堯暉 Division of Cardiovascular Diseases
  • 吳敘平 Division of Cardiovascular Diseases
  • 林柏霖 Division of Cardiovascular Diseases
  • 陳永強 Division of Cardiovascular Diseases
  • 楊翔惟 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Chronic Heart Failure With Reduced Ejection Fraction

Objectives

Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization The first event of CV death or HF hospitalization as confirmed by a clinical events committee (CEC).

Test Drug

MK-1242 (vericiguat)

Active Ingredient

vericiguat hydrochloride

Dosage Form

Tablet

Dosage

2.5/5/10 mg/Tablet

Endpoints

Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization

Inclution Criteria

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.

Exclusion Criteria

Has SBP <100 mm Hg or symptomatic hypotension.
Awaiting heart transplantation, is receiving continuous IV infusion of an inotrope, or has or anticipates receiving an implanted ventricular assist device.
Amyloidosis or sarcoidosis.
Primary valvular heart disease requiring surgical procedure or intervention or has undergone a valvular surgical procedure or intervention within 3 months before randomization.
Hypertrophic cardiomyopathy.
Acute myocarditis or Takotsubo cardiomyopathy.
History of heart transplant.
Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia.
Acute coronary syndrome, or undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 3 months before randomization.
History of symptomatic carotid stenosis, transient ischemic attack (TIA), or stroke within 3 months before randomization.
Malignancy or other noncardiac condition limiting life expectancy to <3 years.
Requires continuous home oxygen for severe pulmonary disease.
Interstitial lung disease.
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.

The Estimated Number of Participants

  • Taiwan

    65 participants

  • Global

    6000 participants