Clinical trial NCT06812546: Efficacy and Safety of Early Initiation of Vericiguat in Heart Failure After Acute Myocardial Infarction
Official title: Efficacy and Safety of Early Initiation of Vericiguat in Heart Failure After Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Heart Failure
Acute Myocardial Infarction (AMI)
Acute Heart Failure (AHF)
Keywords: Vericiguat
Guideline-Directed Medical Therapy
Heart Failure
Acute myocardial infarction
Lead sponsor: Chongqing Emergency Medical Center
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Chongqing Medical University
name: The First Affiliated Hospital of Chongqing Medical Universty
First posted: 2025-02-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a multicenter, prospective, randomized controlled trial in which patients will be randomized into either the experimental or control group by uniform stratification from the main centre.
Primary purpose: TREATMENT

Brief summary: Heart failure (HF) is a severe cardiovascular disease with extremely high morbidity and mortality rates worldwide, and ischemic cardiomyopathy is an important cause of heart failure. Vericiguat is a soluble guanylate cyclase stimulator which has been verified to improve the cardiovascular outcomes in heart failure patients. The VICTORIA trial excluded patients with acute coronary syndrome in 3 months prior to the study start, so it is still unclear about the efficacy and safety of vericiguat in heart failure after acute myocardial infarction. So we conducted this multi-center, prospective, cohort study to estimate the efficacy and safety of vericiguat in HF patients after acute myocardial infarction.

Detailed description: Heart failure (HF) is a severe cardiovascular disease with extremely high morbidity and mortality rates worldwide, and ischemic cardiomyopathy is an important cause of heart failure. According to different studies, acute heart failure occurs in-hospital in about 14-36% of patients after acute myocardial infarction (AMI)1 and the presence of HF on admission or the occurrence of HF during hospitalization in patients with AMI are strong risk factors for poor prognosis. The incidence of HF in AMI varies according to population differences. For example, in patients with STEMI, the incidence of acute heart failure is relatively high because of the greater extent of the infarction and the longer duration of coronary occlusion, whereas patients with NSTEMI, although at lower risk of developing heart failure in the acute phase, have an increased risk of developing chronic heart failure in the long term. Advanced age, previous history of heart failure, chronic kidney disease, multibranch vasculopathy, and delayed opening of the infarct-related artery are major risk factors. In addition, comorbidities such as diabetes and hypertension increase the risk of developing heart failure.

The goals of treatment for HF after AMI are to improve cardiac function, reduce symptoms, and prevent further myocardial injury. Basic therapy consists of prompt opening of the infarct-related artery (e.g., percutaneous coronary intervention) and the administration of optimized pharmacological treatments such as antiplatelets, beta-blockers, ACEI/ARBs and aldosterone antagonists. In the acute phase, diuretics and positive inotropic agents may be used to relieve severe symptoms. Besides, other HF medication such as SGLT2i are effective in patients with heart failure whether or not it is caused by ischemia.

Vericiguat is a soluble guanylate cyclase stimulator which has been verified to improve the cardiovascular outcomes in heart failure patients. The VICTORIA trial excluded patients with acute coronary syndrome in 3 months prior to the study start, so it is still unclear about the efficacy and safety of vericiguat in heart failure after acute myocardial infarction. The VIC-MI trial is a multi-center, prospective, open-label cohort study to estimate the efficacy and safety of vericiguat in HF patients after acute myocardial infarction.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Undertaking revascularization for criminal coronary artery during hospitalization
* Acute heart failure occurs within 14 days in hospital after STEMI or NSTEMI, meeting all of the following criteria: typical symptoms or signs of heart failure; Treatment with oral or intravenous diuretics is required; LVEF measured by echocardiography is ≤ 45%; Elevated levels of NT proBNP in patients with sinus rhythm ≥ 1000pg/ml and atrial fibrillation/flutter ≥ 1600pg/ml
* eGFR ≥ 15 ml/min/1.73m2
* Informed consent has to be given in written form

Exclusion Criteria:

* Plan to undergo staged revascularization or if the criminal coronary artery has not been successfully opened
* Severe and uncontrolled lung diseases, such as newly developed pulmonary embolism, primary pulmonary hypertension, acute exacerbation of COPD, etc
* Severe liver and kidney dysfunction, Child Pugh grade C or eGFR \< 15ml/min/1.73m2
* Allergies to ACEI, ARB, ARNI, beta blockers, SGLT2i, MRA, Vericiguat, and other medications
* Symptomatic hypotension or systolic blood pressure less than 90mmHg after discontinuing intravenous medication
* Women in the perinatal period or those planning to conceive
* Patients planning to undergo elective surgical treatment or tumor chemotherapy
* Diagnosed as Takotsubo cardiomyopathy or nonobstructive acute myocardial infarction (MINOCA)
* Previous diagnosis of cardiomyopathy, including but not limited to dilated cardiomyopathy, hypertrophic cardiomyopathy, etc.
* Autoimmune disease or infectious diseases with typical cardiovascular damage, such as syphilis, systemic lupus erythematosus, etc.
* Diagnosed with severe heart valve disease

Primary outcomes:
measure: Serum NT-proBNP Level
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: 6-minute walk distance
timeFrame: Up to 24 weeks
measure: NYHA functional class
timeFrame: Up to 24 weeks
measure: Worsening heart failure event
timeFrame: Up to 24 weeks
measure: Left ventricular ejection fraction
timeFrame: Up to 24 weeks
measure: Left ventricular end-diastolic diameter
timeFrame: Up to 24 weeks
measure: Left ventricular global longitudinal strain
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
Study officials:
affiliation: Chongqing Central Hospital of Chongqing University, Chongqing Emergency Medical Center
name: Dongying Zhang, Professor
role: STUDY_CHAIR
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