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Vericiguat for Heart Failure With Reduced Ejection Fraction After Myocardial Infarction

NCT ID: NCT06717204

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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HFrEF Myocardial Infarction Vericiguat

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Vericiguat and conventional treatment

Vericiguat in addition to conventional treatment

Vericiguat Oral Tablet [Verquvo]

Intervention Type DRUG

Vericiguat in addition to conventional treatment

Prescription Drugs

Intervention Type DRUG

Conventional treatment only

Conventional treatment only

Conventional treatment only

Prescription Drugs

Intervention Type DRUG

Conventional treatment only

Interventions

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Vericiguat Oral Tablet [Verquvo]

Vericiguat in addition to conventional treatment

Intervention Type DRUG

Prescription Drugs

Conventional treatment only

Intervention Type DRUG

Other Intervention Names

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Conventional treatment Conventional treatment without vericiguat

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinan Central Hospital

OTHER

Sponsor Role collaborator

Qianfoshan Hospital

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Pan-Pan Hao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Panpan Hao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Site Status

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

Jinan, Shandong, China

Site Status

Countries

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China

Central Contacts

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Panpan Hao, MD, PhD

Role: CONTACT

Phone: 86-18560086593

Email: [email protected]

Facility Contacts

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Panpan Hao, MD, PhD

Role: primary

Bin Li, MD, PhD

Role: primary

Zhongwen Zhang, MD, PhD

Role: primary

Other Identifiers

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Vericiguat for HFrEF

Identifier Type: -

Identifier Source: org_study_id