Evaluating Qishen Granules for Heart Failure with Preserved Ejection Fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remote rehabilitation for HFpEF patients using telerehabilitation

  A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.

  Recruiting at 3 sites American Heart of Poland · Chrzanów and 2 other locations · NCT07918209

• EDG-15400 in adults with HFpEF: a phase 2 study

  This phase 2 study tests different doses of EDG-15400 against placebo in adults with HFpEF to see if it is safe and tolerable.

  Recruiting at 4 sites Phase 2 Edgewise Therapeutics, Inc. · Birmingham, Alabama and 27 other locations · NCT07795814

• Incretin therapy with tirzepatide for obesity-related HFpEF

  A 15-month study will test whether tirzepatide helps people with obesity and HFpEF by reducing plasma volume.

  Recruiting Phase 4 Columbia University · New York, New York · NCT07554638

• Boosted exercise with group coaching for HFpEF

  This trial tests a blended, guided exercise program with group coaching and remote monitoring to see if it helps older adults with HFpEF improve activity and health at a lower cost.

  Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT07413198

• Exercise cardiac MRI for heart failure with preserved ejection fraction

  This study will try low-field exercise cardiac MRI to see if it can diagnose, describe, and predict risk in people with HFpEF compared with those who have non-cardiac breathlessness and healthy volunteers.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07401771

• HRS-1893 for heart failure with preserved ejection fraction

  This trial will test whether HRS-1893 is safe and tolerable in adults aged 40 and older who have heart failure with preserved ejection fraction.

  Recruiting Phase 2 Shandong Suncadia Medicine Co., Ltd. · Shanghai, Shanghai Municipality · NCT07269717

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.