NCT06377761Recruiting
Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules
A Randomized, Double-blind, Placebo-controlled Study on the Treatment of Heart Failure with Preserved Ejection Fraction with Qishen Granules Based on Cardiopulmonary Exercise Test
Source: ClinicalTrials.gov · Last updated 18 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
With the cardiopulmonary exercise testing as the primary outcome, the study aims to evaluate the efficacy of Qishen Granules on cardiac function, quality of life and biomarker level of patients with heart failure with preserved ejection fraction (HFpEF), which will provide evidence for the treatment of HFpEF with traditional Chinese medicine.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 2 Jun 2022
- Start date
- 1 May 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Diseases
- Heart failure
- NCT number
- NCT06377761
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 May 2023 to the primary completion date, 31 Dec 2025
- 2 sites 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
- Currently participating in another research equipment or drug test, or less than 30 days after the completion of another research equipment or drug test or receiving other research treatment. Patients participating in purely observational trials will not be excluded
Other illness
- Patients with decompensated heart failure
- Resting heart rate recorded by echocardiography at the time of screening\>110bpm
- Be allergic to any component of Qishen granules (astragalus membranaceus, salvia miltiorrhiza, and black aconite)
Lab values
- Glomerular filtration rate (eGFR)\<30mL/min/1.73m 2
- Atrial fibrillation or atrial flutter with obvious liver disease or ALT, AST 3 times higher than the upper limit of normal
Other
- Symptomatic hypotension or systolic blood pressure (SBP)\<100mmHg at the time of inclusion or baseline
- At present, people who are taking traditional Chinese medicine or Chinese patent medicine with similar effect to Qishen Granules
- Patients who refuse to sign the informed consent form or estimate poor compliance and women who are pregnant, nursing or planning to become pregnant during the trial
Who the study is looking for
- Sign the informed consent form
- Age 18-85 years old
- Heart failure was diagnosed ≥ 3 months before enrollment, The heart function classification II-IV of New York Heart Association (NYHA)
- has ≥ 1 of the following: 1） Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) recorded by echocardiography at the time of enrollment；2）Hospitalization due to heart failure within 12 months before enrollment
- Retention of ejection fraction: left ventricular ejection fraction (LVEF)≥50% (Echocardiography)
- Increase of NTpro-BNP (patients without atrial fibrillation\>220pg/mL, patients with atrial fibrillation\>660pg/mL
- If diuretics are being administered orally, the dose must be stable for ≥ 2 weeks before inclusion in the study
- At the time of randomization, it was clinically stable without signs of decompensation of cardiac failure (judged by the investigator)
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| WangLei Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.