Vericiguat for Heart Failure With Reduced Ejection Fraction After Myocardial Infarction (HFrEF)

December 1, 2024 updated by: Pan-Pan Hao, Qilu Hospital of Shandong University

Vericiguat for Ventricular Remodeling in Patients With Heart Failure With Reduced Ejection Fraction After Myocardial Infarction

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
        • Principal Investigator:
          • Panpan Hao, MD, PhD
        • Contact:
      • Jinan, Shandong, China, 250013
        • Central Hospital Affiliated to Shandong First Medical University
        • Contact:
        • Sub-Investigator:
          • Bin Li, MD, PhD
      • Jinan, Shandong, China, 250031
        • The First Affiliated Hospital of Shandong First Medical University/Shandong Province Qianfoshan Hospital
        • Contact:
        • Sub-Investigator:
          • Zhongwen Zhang, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vericiguat and conventional treatment
Vericiguat in addition to conventional treatment
Drug: Vericiguat Oral Tablet [Verquvo]
Vericiguat in addition to conventional treatment
Other Names:
  • Conventional treatment
Drug: Prescription Drugs
Conventional treatment only
Other Names:
  • Conventional treatment without vericiguat
Conventional treatment only
Drug: Prescription Drugs
Conventional treatment only
Other Names:
  • Conventional treatment without vericiguat

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Collaborators

Qianfoshan Hospital
Jinan Central Hospital

Investigators

  • Principal Investigator: Panpan Hao, MD, PhD, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 1, 2024

First Submitted That Met QC Criteria

December 1, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 1, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vericiguat for HFrEF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Institutional policy and patient privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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