Vericiguat for Heart Failure With Reduced Ejection Fraction After Myocardial Infarction

Not yet recruiting

• Conditions: HFrEF - Heart Failure With Reduced Ejection Fraction; Myocardial Infarction (MI)
• Interventions: Drug: Vericiguat Oral Tablet [Verquvo]; Drug: Prescription Drugs

• Registration Number: NCT06717204
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

The effects of vericiguat on cardiac remodeling in patients with chronic stable heart failure after myocardial infarction have not been reported. This project aims to clarify the efficacy and safety of vericiguat in patients with chronic heart failure after myocardial infarction. Patients with chronic stable heart failure with reduced ejection fraction after...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-01
• Last Update Submitted: 2024-12-01
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Study Start: 2025-01-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. The history of acute myocardial infarction exceeds 3 months;
2. Symptoms and signs of heart failure have been stable for more than one month;
3. 18 years old or more;
4. NYHA cardiac function classified as grade II~IV;
5. LVEF≤40%；
6. NT-proBNP≥450pg/ml；
7. All subjects or their guardians must sign the subject consent before entering the trial.

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Exclusion Criteria

1. Patients with the following diseases: nonischemic cardiomyopathy; valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor;
2. Mechanical complications of myocardial infarction;
3. Unable to obtain primary outcome data.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vericiguat and conventional treatment	Vericiguat Oral Tablet [Verquvo]	Vericiguat in addition to conventional treatment
Vericiguat and conventional treatment	Prescription Drugs	Vericiguat in addition to conventional treatment
Conventional treatment only	Prescription Drugs	Conventional treatment only

Primary Outcome Measures

Name	Time	Method
LVEDVI=LVEDV/BSA	From baseline to the end of 12-month treatment	Changes of left ventricular end-diastolic volume index (LVEDVI) compared with baseline after 12 months

Trial Locations

Locations (3)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

Central Hospital Affiliated to Shandong First Medical University; 🇨🇳 Jinan, Shandong, China

The First Affiliated Hospital of Shandong First Medical University/Shandong Province Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China