Evaluating Qishen Granules for Heart Failure with Preserved Ejection Fraction
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
This study is testing if Qishen Granules can help improve heart function and quality of life for people with heart failure that has preserved ejection fraction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Guangdong Provincial Hospital of Traditional Chinese Medicine Academic / other |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT06377761 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy of Qishen Granules in improving cardiac function, quality of life, and biomarker levels in patients with heart failure with preserved ejection fraction (HFpEF). Utilizing cardiopulmonary exercise testing as the primary outcome measure, the study will evaluate peak oxygen consumption and other indicators to determine the granules' effectiveness. The research is grounded in traditional Chinese medicine principles and seeks to provide evidence for its use in treating HFpEF. Participants will undergo a comprehensive evaluation including echocardiographic measures and various biomarkers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with a diagnosis of heart failure for at least three months and preserved ejection fraction.
Not a fit: Patients with decompensated heart failure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option that improves exercise capacity and quality of life for patients with HFpEF.
How similar studies have performed: Previous studies have shown positive effects of traditional Chinese medicine combined with conventional treatments for HFpEF, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Sign the informed consent form 2. Age 18-85 years old 3. Heart failure was diagnosed ≥ 3 months before enrollment, The heart function classification II-IV of New York Heart Association (NYHA) 4. 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 5. Retention of ejection fraction: left ventricular ejection fraction (LVEF)≥50% (Echocardiography) 6. Increase of NTpro-BNP (patients without atrial fibrillation\>220pg/mL, patients with atrial fibrillation\>660pg/mL 7. If diuretics are being administered orally, the dose must be stable for ≥ 2 weeks before inclusion in the study 8. At the time of randomization, it was clinically stable without signs of decompensation of cardiac failure (judged by the investigator) Exclusion Criteria: 1. Patients with decompensated heart failure 2. Glomerular filtration rate (eGFR)\<30mL/min/1.73m 2 3. Atrial fibrillation or atrial flutter with obvious liver disease or ALT, AST 3 times higher than the upper limit of normal 4. Symptomatic hypotension or systolic blood pressure (SBP)\<100mmHg at the time of inclusion or baseline 5. Resting heart rate recorded by echocardiography at the time of screening\>110bpm 6. 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 7. At present, people who are taking traditional Chinese medicine or Chinese patent medicine with similar effect to Qishen Granules 8. Be allergic to any component of Qishen granules (astragalus membranaceus, salvia miltiorrhiza, and black aconite) 9. 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
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- Guangdong Provincial Hospital of Chinese Medicine — Guangzhou, Guangdong, China (Recruiting)
- WangLei — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Lei Wang, doctorate
- Email: Dr.wanglei@139.com
- Phone: 8620-81887233-3280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.