Clinical trial NCT06717204: Vericiguat for Heart Failure With Reduced Ejection Fraction After Myocardial Infarction
Official title: Vericiguat for Ventricular Remodeling in Patients With Heart Failure With Reduced Ejection Fraction After Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HFrEF - Heart Failure With Reduced Ejection Fraction
Myocardial Infarction (MI)
Keywords: HFrEF
Myocardial Infarction
Vericiguat
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Jinan Central Hospital
name: Qianfoshan Hospital
First posted: 2024-12-04
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic heart failure with reduced ejection fraction after myocardial infarction

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.


Eligibility criteria: 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.

Primary outcomes:
measure: LVEDVI=LVEDV/BSA
timeFrame: From baseline to the end of 12-month treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Central Hospital Affiliated to Shandong First Medical University
state: Shandong
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University/Shandong Province Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Panpan Hao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: