The Anti-myocardial Fibrosis Effect of Vericiguat in HFrEF

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Vericiguat is a new medication therapy choice for the patients with heart failure with reduced ejection fraction (HFrEF), in the latest trial, it met the expectation to reduce incidence of death from cardiovascular causes or hospitalization for heart failure among HFrEF patients. Myocardial fibrosis as a pathological change in heart failure, it contributes to left ventricular dysfunction leading to development of the disease, experimental studies have showed the potential prevention, or even reversal effect of sGC stimulators in left ventricular hypertrophy and fibrosis. Our study is a prospective controlled clinical trial aim to verify the anti-myocardial fibrosis effect of vericiguat in heart failure with reduced ejection fraction.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chongqing Medical University

Criteria

Inclusion Criteria:

1. Age ≥ 18 years who agreed to join in and signed the informed consent.

2. Diagnosed with HFrEF according to the 2022 AHA guidelines of 2022 AHA/ACC/HFSA guideline and 2021 ESC guideline for the chronic heart failure.

3. Left ventricular ejection fraction ≤45% measured by CMR or echocardiogram.

4. NYHA classes II - IV

Exclusion Criteria:

1. Patients who are receiving phosphodiesterase type 5 (PDE5) inhibitors or other sGC stimulators therapy.

2. LVEF measured by the UCG >45%.

3. Contraindication to CMR.

4. History of allergic or hypersensitivity to drugs involved in the trial or Congenital glucose-galactose intolerance.

5. Patients with a known history of cancer, angioedema.

6. Patients with rheumatic valvular heart disease and significant congenital heart disease.

7. Patients diagnosed with Hypertrophic obstructive cardiomyopathy, myocarditis, Fabry disease, amyloidosis, sarcoidosis, or pericardial disease.

8. Acute coronary syndrome, including unstable angina, Non ST-elevation myocardial infarction or ST-elevation myocardial infarction, or Coronary artery bypass grafting (CABG) within 3 months prior to the trial start, or indication for Percutaneous coronary intervention (PCI) or CABG at the trial start.

9. Interstitial lung disease , severe chronic obstructive pulmonary disease (COPD) and chronic thrombotic pulmonary disease.

10. SBP≥180mmHg or DBP≥120mmHg at visit, DBP≤90mmHg or symptomatic hypotension.

11. Pregnant woman.

12. Chronic kidney disease and eGFR≤30ml/min/1.73m² or accepting long-term hemodialysis.

13. Hepatic insufficiency classified as Child-Pugh B or C.

14. Fatal or uncontrollable heart arrythmia e.g., symptomatic or persistence ventricular tachycardia, ventricular rate>150 bpm in AF patients.

15. Patients with pacemaker.