Heart Failure With Preserved Ejection Fraction Clinical Trial
— HFpEFOfficial title:
A Randomized,Double-blinded, Placebo-controlled Trial Evaluating the Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency
This study was designed as a randomized, double blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the efficacy and safety of Zhigancao Tang granule in patients with HFpEF of Qi-Yin dificiency.
Status | Not yet recruiting |
Enrollment | 122 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Comply with the diagnostic criteria of Western medicine for HFpEF and the diagnostic criteria for TCM syndromes of Qi-Yin deficiency; 2. Cardiac function classification by NYHA: grade I to III; 3. Age between 30 and 80 years old; 4. Those who volunteer to participate in clinical trial observation, sign informed consent and indicate date; 5. During the observation period, those who do not take other drugs other than those specified and can insist on completing the treatment and observation. Exclusion Criteria: 1. Valvular heart disease, restrictive cardiomyopathy, pericardial disease; 2. Decompensated heart failure is unstable after treatment; 3. Combined with atrial fibrillation; 4. Patients with severe lung, liver, endocrine system and kidney dysfunction; 5. Patients with cancer and other common malignant diseases reducing life expectancy; 6. Pregnant or lactating women; 7. Allergic constitution or allergic history to common drugs; 8. Patients with mental illness or poor compliance of traditional Chinese medicine treatment. |
Country | Name | City | State |
---|---|---|---|
China | Longhua Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai University of Traditional Chinese Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac Functional Grading | Significant effect: cardiac function recovered to level 1 or increased by level 2; Effective: cardiac function increased by level 1 but failed to reach level 2; Ineffective: cardiac function did not change; Worsening: cardiac function decreased by level 1 or above. | 12 weeks | |
Secondary | Ultrasonic cardiogram | Echocardiographic measurement of Left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDd), left ventricular end systolic diameter (LVESD), ratio of left ventricular early diastolic fast filling peak to late diastolic filling peak (E / a), ratio of early diastolic velocity of mitral valve to early diastolic annular velocity (E / E '). | 12 weeks | |
Secondary | 6-min walking test (6mwt) | 6 minute walking test (6mwt) is a measure of the distance the patient can reach as far as possible by walking on a hard ground without obstacles within six minutes at the fastest possible speed. It provides a comprehensive assessment of exercise capacity. | 12 weeks | |
Secondary | Minnesota Heart Failure Quality of Life Scale | Minnesota Heart Failure Quality of Life Scale was used to assess the impact of heart failure on life in the last four weeks. A total of 21 questions related to physical and emotional change. Higher scores mean a worse outcome. | 12 weeks | |
Secondary | N-terminal pro-B-type natriuretic peptide(NT-proBNP) | NT-proBNP is a reliable and sensitive indicator of heart failure. Its elevation is positively correlated with severity of heart failure. | 12 weeks | |
Secondary | TCM syndrome score | TCM syndrome score is used to assess changes in Qi-Yin Dificiency related symptoms during treatment. The higher the scores, the more heart failure symptoms. Higher scores mean a worse outcome. | 12 weeks |
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