NCT06377761 Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules
| NCT ID | NCT06377761 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guangdong Provincial Hospital of Traditional Chinese Medicine |
| Condition | Heart Failure with Preserved Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2023-05-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Lei Wang, doctorate
STUDY DIRECTOR
Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China
Frequently Asked Questions
Who can join the NCT06377761 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Heart Failure with Preserved Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06377761 currently recruiting?
Yes, NCT06377761 is actively recruiting participants. Contact the research team at Dr.wanglei@139.com for enrollment information.
Where is the NCT06377761 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China.
Who is sponsoring the NCT06377761 clinical trial?
NCT06377761 is sponsored by Guangdong Provincial Hospital of Traditional Chinese Medicine. The principal investigator is Lei Wang, doctorate at Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. The trial plans to enroll 80 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.