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Study on the efficacy and safety of Vericiguat in patients with heart failure after myocardial infarction

Study on the efficacy and safety of Vericiguat in patients with heart failure after myocardial infarction

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077753
Enrollment
Unknown
Registered
2023-11-17
Start date
2023-07-01
Completion date
Unknown
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure after myocardial infarction

Interventions

Experimental group:Conventional treatment+ Vericiguat 2.5-10mg qd
Control group:Conventional treatment

Sponsors

China-Japan Union Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Written informed consent is obtained. 2. Aged >= 18 years. 3. Hospitalization for acute myocardial infarction (AMI). Definition of AMI: Acute myocardial injury [evidenced by a rise and/or fall of serum cardiac troponin values, with at least one value above the 99th percentile upper reference limit (URL)] with clinical evidence of acute myocardial ischemia. This evidence includes at least one of the following: (1) Symptoms of acute myocardial ischemia; (2) New ischemic electrocardiographic (ECG) changes; (3) Development of pathological Q waves; (4) Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with ischemic etiology; (5) Identification of a coronary thrombus by angiography or intracoronary imaging. 4. Left ventricular ejection fraction (LVEF) <= 50% as assessed by echocardiography on admission. LVEF Assessment Method: LVEF is primarily evaluated using echocardiography. The reported LVEF value should be the average of three independent measurements. All echocardiographic assessments must be reviewed and confirmed by two cardiologists.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to vericiguat or any of its excipients. 2. Concurrent use of other soluble guanylate cyclase (sGC) stimulators (e.g., riociguat) or phosphodiesterase type 5 (PDE5) inhibitors (e.g., sildenafil). 3. Persistent systolic blood pressure (SBP) = 3 consecutive measurements, or the presence of symptomatic hypotension (e.g., dizziness, headache, fatigue, pallor, weakness). 4. Known history of chronic heart failure (HF) prior to the index event. 5. Presence of any non-cardiac condition (including active malignancy) expected to limit life expectancy to less than 12 months. 6. Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) 3 times the upper limit of normal (ULN). 8. Pregnancy, lactation, or planned pregnancy in the near future. 9. Inability or unwillingness to comply with follow-up procedures.

Design outcomes

Primary

MeasureTime frame
Whether the left ventricular ejection fraction (LVEF) increased by >= 10% (from baseline);

Secondary

MeasureTime frame
NT-proBNP;Cardiac death;Re-hospitalization for heart failure;All-cause mortality;left ventricular ejection fraction;left atrial diameter;left ventricular end-diastolic diameter;mitral regurgitation area;

Countries

China

Contacts

Public ContactHe Yuquan

China-Japan Union Hospital of Jilin University

heyq@jlu.edu.cn+86 139 4414 5413

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026