Actively Recruiting
Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules
Led by Guangdong Provincial Hospital of Traditional Chinese Medicine · Updated on 2024-12-18
80
Participants Needed
2
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age between 18 and 85 years
- Diagnosed with heart failure at least 3 months before enrollment
- New York Heart Association (NYHA) heart function classification II to IV
- At least one of the following: structural heart disease by echocardiography or hospitalization for heart failure within 12 months
- Left ventricular ejection fraction (LVEF) of 50% or higher
- Elevated NT-pro BNP: >220 pg/mL without atrial fibrillation, >660 pg/mL with atrial fibrillation
- Stable dose of oral diuretics for at least 2 weeks before study entry
- Clinically stable without signs of heart failure worsening at randomization
You will not qualify if you...
- Decompensated heart failure
- Glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2
- Atrial fibrillation or flutter with significant liver disease or liver enzymes (ALT, AST) three times above normal
- Symptomatic low blood pressure or systolic blood pressure below 100 mmHg at baseline
- Resting heart rate over 110 bpm at screening
- Current participation in other drug or device trials or less than 30 days since last participation
- Current use of traditional Chinese medicine similar to Qishen Granules
- Allergy to components of Qishen Granules (astragalus membranaceus, salvia miltiorrhiza, black aconite)
- Refusal to sign consent, poor compliance, or pregnancy, breastfeeding, or planning pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China, 510120
Actively Recruiting
2
WangLei
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
L
Lei Wang, doctorate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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