Vericiguat for Heart Failure With Reduced Ejection Fraction After Myocardial Infarction

NCT06717204 | Not Yet Recruiting DMC FDA Drug

• 1 other identifier: Vericiguat for HFrEF
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 3

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 myocardial infarction in the electronic medical records of Qilu Hospital of Shandong University will be selected and divided into two groups: the treatment group received vericiguat in addition to conventional treatment and the control group received conventional treatment only. After 12-month treatment, the effects of vericiguat on cardiac remodeling and function and cardiovascular adverse events will be evaluated. The results are helpful to provide a new treatment strategy for chronic heart failure after myocardial infarction.

Conditions

HFrEF - Heart Failure With Reduced Ejection Fraction; Myocardial Infarction (MI)

Keywords

HFrEF; Myocardial Infarction; Vericiguat

Outcome Measures

Primary Outcomes (1)

• LVEDVI=LVEDV/BSA

  Changes of left ventricular end-diastolic volume index (LVEDVI) compared with baseline after 12 months

  From baseline to the end of 12-month treatment

Study Arms (2)

Vericiguat and conventional treatment

Vericiguat in addition to conventional treatment

Drug: Vericiguat Oral Tablet [Verquvo]; Drug: Prescription Drugs

Conventional treatment only

Conventional treatment only

Drug: Prescription Drugs

Interventions

Vericiguat Oral Tablet [Verquvo] DRUG

Vericiguat in addition to conventional treatment

Also known as: Conventional treatment

Vericiguat and conventional treatment

Prescription Drugs DRUG

Conventional treatment only

Also known as: Conventional treatment without vericiguat

Conventional treatment only; Vericiguat and conventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic heart failure with reduced ejection fraction after myocardial infarction

You may qualify if:

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

You may not qualify if:

• 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;
• Mechanical complications of myocardial infarction;
• Unable to obtain primary outcome data.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Jinan Central Hospital: collaborator
• Qianfoshan Hospital: collaborator

Study Sites (3)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250013, China

Location

The First Affiliated Hospital of Shandong First Medical University/Shandong Province Qianfoshan Hospital

Jinan, Shandong, 250031, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Myocardial Infarction

Interventions

vericiguat; Prescription Drugs

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Panpan Hao, MD, PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panpan Hao, MD, PhD

CONTACT

86-18560086593; panda.how@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 4, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

CN (3)