Efficacy and Safety of Early Initiation of Vericiguat in Heart Failure After Acute Myocardial Infarction
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorDongying Zhang
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Vericiguat
DrugPatients 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Vericiguat Treatment GroupExperimental treatment 1 intervention
Group B: Standard Treatment GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Serum NT-proBNP Level
The primary endpoint of the study is NT-proBNP at the baseline \& at the completion of the 24 week intervention
Time frame
Up to 24 weeksSecondary outcomes
1
6-minute walk distance
6-minute walk distance at the baseline \& at the completion of the 24 week intervention
Time frame
Up to 24 weeks2
NYHA functional class
NYHA functional class at the baseline \& at the completion of the 24 week intervention
Time frame
Up to 24 weeks3
Worsening heart failure event
Time to first worsening heart failure event in 24 weeks after randomization
Time frame
Up to 24 weeks4
Left ventricular ejection fraction
LVEF measured by echocardiography at the baseline \& at the completion of the 24 weeks intervention
Time frame
Up to 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dongying Zhang
Lead sponsor
Chongqing Emergency Medical Center
Sponsor institution
The Second Affiliated Hospital of Chongqing Medical University
Collaborator
The First Affiliated Hospital of Chongqing Medical Universty
Collaborator
Source ClinicalTrials.gov
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