NCT06478732Not yet recruiting
HeartMed-HF Digital Therapeutics Improves Exercise Capacity in CHF Patients After AMI
HeartMed-HF Digital Therapeutics Improves Exercise Capacity in Patients With Chronic Heart Failure After Acute Myocardial Infarction: an International, Multi-center, Randomized Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 16 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Chronic heart failure (HF) is a severe manifestation and terminal stage of various cardiovascular diseases, with high incidence and mortality rates. Myocardial infarction (MI) is currently one of the most common and significant causes of HF globally. The occurrence of HF after MI significantly increases the mortality risk for patients. Actively controlling risk factors and strengthening outpatient management of HF patients post-MI are crucial for alleviating clinical symptoms and enhancing exercise capacity. Recently, digital health interventions (DHI) have shown promising potential in managing cardiovascular disease patients. However, the application in patients with HF post-MI has not been well-reported. Therefore, this study independently and innovatively designed the HeartMed-HF digital therapeutics to demonstrate its effectiveness and safety in patients with HF after MI.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 710 (estimated)
- First submitted
- 17 Jun 2024
- Start date
- 30 Jul 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Heart failure
- NCT number
- NCT06478732
What you commit to
- Study type: Interventional
- Planned participants: 710
- From 30 Jul 2024 to the primary completion date, 31 Dec 2026
- No sites listed in no 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.
Other illness
- History of viral cardiomytis or non-ischemic cardiomyopathy including dilated cardiomyopathy, hypertrophic cardiomyopathy, perinatal cardiomyopathy, etc.
- Moderate to severe valvular heart disease or a history of valve replacement.
- Malignant tumors or other diseases, with expected life expectancy \<1 year.
- Any other clinical conditions unsuitable for this study by the investigator.
Lab values
- Severe liver dysfunction \[ALT ≥ 3 times the upper limit of normal range or renal dysfunction (eGFR\<60 mL /min/1.73m2)\].
Other
- Contraindications to cardiopulmonary exercise testing (bicycle ergometer) or 6-minute walking test.
- Pregnancy, breastfeeding, or planning pregnacy within 1 year.
- Patients who have undergone mechanical circulatory support (including intra-aortic balloon pump, Impella, ECMO, etc.) or endotracheal intubation.
- Inability to use smartphones or communicate with the management team for any reason.
- Enrolled in other clinical trials.
Who the study is looking for
- Be of either sex with age ≥ 18 years and ≤ 75 years.
- Hospitalization due to AMI (onset to randomization ≤ 2 weeks), including STEMI and NSTEMI.
- Meeting the diagnostic criteria for chronic HF, including:
- (1) Symptoms and/or signs of heart failure; (2) LVEF (Simpson's method) \< 50%, and NT-proBNP ≥ 125pg/mL before enrollment. 4. Patients must be willing to comply with the study protocol and give the informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.