Efficacy and Safety of Early Initiation of Vericiguat in Heart Failure After Acute Myocardial Infarction (VIC-MI)

February 2, 2025 updated by: Dongying Zhang
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Chongqing, China, 400000
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • BAY1021189
No Intervention: Standard Treatment Group
Patients enrolled in the controlled group will receive 26 weeks of standard heart failure and coronary heart disease treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum NT-proBNP Level
Time Frame: Up to 24 weeks
The primary endpoint of the study is NT-proBNP at the baseline & at the completion of the 24 week intervention
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-minute walk distance
Time Frame: Up to 24 weeks
6-minute walk distance at the baseline & at the completion of the 24 week intervention
Up to 24 weeks
NYHA functional class
Time Frame: Up to 24 weeks
NYHA functional class at the baseline & at the completion of the 24 week intervention
Up to 24 weeks
Worsening heart failure event
Time Frame: Up to 24 weeks
Time to first worsening heart failure event in 24 weeks after randomization
Up to 24 weeks
Left ventricular ejection fraction
Time Frame: Up to 24 weeks
LVEF measured by echocardiography at the baseline & at the completion of the 24 weeks intervention
Up to 24 weeks
Left ventricular end-diastolic diameter
Time Frame: Up to 24 weeks
LVEDD measured by echocardiography at the baseline & at the completion of the 24 week intervention
Up to 24 weeks
Left ventricular global longitudinal strain
Time Frame: Up to 24 weeks
GLS measured by echocardiography at the baseline & at the completion of the 24 week intervention
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dongying Zhang

Collaborators

The Second Affiliated Hospital of Chongqing Medical University
The First Affiliated Hospital of Chongqing Medical Universty

Investigators

  • Study Chair: Dongying Zhang, Professor, Chongqing Central Hospital of Chongqing University, Chongqing Emergency Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

February 2, 2025

First Submitted That Met QC Criteria

February 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 2, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIC-MI
  • 82300372; 82270406 (Other Grant/Funding Number: National Natural Science of Foundation of China)
  • CSTB2024NSCQ-LZX0144 (Other Grant/Funding Number: Chongqing Natural Science Foundation Joint Fund for Innovation and Development)
  • 2022MSXM028 (Other Grant/Funding Number: Chongqing medical scientific research project (Joint project of Chongqing Health Commission and Science and Technolog))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan to share IPD is not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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