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

NCT ID: NCT06812546

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-12-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vericiguat Treatment Group

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.

Group Type: EXPERIMENTAL

Vericiguat

Intervention Type: DRUG

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.

Standard Treatment Group

Patients enrolled in the controlled group will receive 26 weeks of standard heart failure and coronary heart disease treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

BAY1021189

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Chongqing Medical Universty

UNKNOWN

Sponsor Role: collaborator

Dongying Zhang

OTHER

Sponsor Role: lead

Responsible Party

Dongying Zhang

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dongying Zhang, Professor

Role: STUDY_CHAIR

Chongqing Central Hospital of Chongqing University, Chongqing Emergency Medical Center

Locations

The First Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Countries

China

Central Contacts

Dongying Zhang, Professor

Role: CONTACT

zhangdongying@cqu.edu.cn

86-13608398395

Junlong Chen, M.D.

Role: CONTACT

junlongchen2024@163.com

86-15111871817

Facility Contacts

Lei Gao, M.D.

Role: primary

653161583@qq.com

86-15123908507

References

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Other Identifiers

82300372; 82270406

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CSTB2024NSCQ-LZX0144

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2022MSXM028

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

VIC-MI

Identifier Type: -

Identifier Source: org_study_id