NCT05799638Completed
Strategy, Efficacy and Safety of Medication Usage in Heart Failure Patients Who Were Intolerable to GDMT
Medication Strategies in Heart Failure Patients Who Are Intolerable to Guideline-directed Medical Therapy
Source: ClinicalTrials.gov · Last updated 1 Aug 2024
Brief summary (registry, in English)
SEMI trial is a single-center, real-world based prospective cohort study. The study enrolled acute heart failure patients admitting to the hospital and intended to accept heart failure therapy. The current guideline recommend ACEI/ARB/ARNI, β blocker, SGLT2i and MRA as the cornerstone medication of HFrEF therapy, but a part patients were intolerable to GDMT because of hypotension, hyperkalemia or renal insufficency. Vericiguat is a new medication therapy choice for the patients with heart failure with reduced ejection fraction (HFrEF), it may has less influence on blood pressure, it is unkonwn about the efficacy and safety of vericiguat in patients who were intolerable to GDMT.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 263 (actual)
- First submitted
- 12 Mar 2023
- Start date
- 1 Jan 2023
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Chongqing Medical University
- Diseases
- Heart failure
- NCT number
- NCT05799638
What you commit to
- Study type: Observational
- Participants enrolled: 263
- From 1 Jan 2023 to the primary completion date, 31 Dec 2023
- 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 design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Dignosed with acute coronary syndrome, including unstable angina, non ST-elevation myocardial infarction and ST-elevation myocardial infarction. Received percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to the trial start, or indication for PCI or CABG at the trial start.
- Diagnosed with idiopathic pulmonary hypertension, receiving PDE-5 inhibitor or other sGC stimulators.
Other illness
- Allergic to anti-heart failure medications including ACEI/ARB/ARNI, beta blockers, SGLT2i, oral diuretics and vericiguat.
- Diagnosed as other diseases with symptoms similar to heart failure such as acute exacerbation of chronic obstructive pulmonary disease, etc.
- Hepatic insufficiency classified as Child-Pugh B or C.
- Diagnosed with cardiac amyloidosis, Fabry disease or other rare cardiomyopathy.
- Diagnosed with systematic lupus erythematosus or other autoimmune disease.
- Combined with severe infection at admission or combined with uncontrolled tuberculosis.
- Diagnosed with severe and uncontrolled congenital heart disease.
- Patients with rheumatic valvular disease who have indications for surgery but have not undergone surgical treatment.
Lab values
- Left ventricular ejection fraction measured by echocardiogram \> 45% or diagnosed with heart failure with preserved ejection fraction.
Age
- Age ≤ 18 years old.
Other
- Diagnosed with restrictive cardiomyopathy.
- Diagnosed with or suspect diagnosed with active tumor.
- Pregnant woman.
Who the study is looking for
- Sent to the Department of Cardiovascular disease of The First Affiliated Hospital of Chongqing Medical University for inpatient treatment.
- Diagnosed with acute heart failure or acute exacerbation of chronic heart failure
- Patients with typical heart failure symptoms and signs such as dyspnea, fatigue after exercise, paroxysmal nocturnal dyspnea, lower limb edema, lung auscultation rale, etc.
- Left ventricular ejection fraction measured by echocardiogram ≤ 45% and patients had elevated level of NT-proBNP (patients\<55 years, NT-proBNP\>450 pg/mL; patients≥55 years and \<75 years, NT-proBNP\>900 pg/mL; patients ≥ 75 years, NT-proBNP\>1800 pg/mL)
- New York Heart Association functional class II to IV.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile 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 |
Related publications
- Efficacy of Vericiguat in Acute Heart Failure: A Target Trial Emulation Study.J Am Heart Assoc · 2026 · PMID 41848038
This page is information, not medical advice. Discuss any trial with your doctor.