NCT06812546

Efficacy and Safety of Early Initiation of Vericiguat in Heart Failure After Acute Myocardial Infarction

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Dongying Zhang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Acute Myocardial Infarction (AMI)
• Acute Heart Failure (AHF)

Interventions

Type	Name	Description
DRUG	Vericiguat	Patients enrolled in the experimental group will receive 26 weeks of oral vericiguat on top of the standard treatment, with vericiguat at a dose of 2.5 mg once a day, doubled every fortnight to a maximum dose of 10 mg once a day at the end of week 6 of the visit, which will be maintained for the duration of the treatment.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-06-30
• Completion: 2026-12-30
• First posted: 2025-02-06
• Last updated: 2025-02-06

Locations

1 site across 1 country: China