NCT06812546Not yet recruitingPhase 4
Efficacy and Safety of Early Initiation of Vericiguat in Heart Failure After Acute Myocardial Infarction
Source: ClinicalTrials.gov · Last updated 6 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 2 Feb 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Dongying Zhang
- Diseases
- Heart failure
- NCT number
- NCT06812546
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From 1 Apr 2025 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Symptomatic hypotension or systolic blood pressure less than 90mmHg after discontinuing intravenous medication
- Patients planning to undergo elective surgical treatment or tumor chemotherapy
- Previous diagnosis of cardiomyopathy, including but not limited to dilated cardiomyopathy, hypertrophic cardiomyopathy, etc.
Other illness
- Severe and uncontrolled lung diseases, such as newly developed pulmonary embolism, primary pulmonary hypertension, acute exacerbation of COPD, etc
- Allergies to ACEI, ARB, ARNI, beta blockers, SGLT2i, MRA, Vericiguat, and other medications
- Diagnosed as Takotsubo cardiomyopathy or nonobstructive acute myocardial infarction (MINOCA)
- Autoimmune disease or infectious diseases with typical cardiovascular damage, such as syphilis, systemic lupus erythematosus, etc.
- Diagnosed with severe heart valve disease
Lab values
- Severe liver and kidney dysfunction, Child Pugh grade C or eGFR \< 15ml/min/1.73m2
Other
- Plan to undergo staged revascularization or if the criminal coronary artery has not been successfully opened
- Women in the perinatal period or those planning to conceive
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.