Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
heart failure with preserved ejection fraction, Qi-Yin deficiency syndrome, randomized, double blinded and controlled trial, Zhigancao Tang granule
Brief summary
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.
Detailed description
Heart failure with preserved ejection fraction (HFPEF) is a clinical syndrome characterized by diastolic dysfunction.The incidence of HFpEF is increasing in recent years. Standard treatment of heart failure does not improve the prognosis of HFPEF patients. Zhigancao Tang was used to improve the symptoms of chronic heart failure in China.This randomized,double-blinded and placebo-controlled trial will objectively and standardly evaluate the effectiveness and safety of Zhigancao Tang granule.After 12 weeks of treatment, 122 HFpEF patients with deficiency of Qi and Yin were observed and evaluated in terms of heart function, clinical symptoms,exercise tolerance and quality of life.
Interventions
DRUGZhigancao Tang granule
Zhigancao Tang: Dissolve Zhigancao Tang granule in 200ml hot water, twice a day,12 weeks, oral. Standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters and diuretics as needed.
DRUGZhigancao Tang placebo granule
Zhigancao Tang placebo: Dissolve Zhigancao Tang placebo granule in 200ml hot water, twice a day,12 weeks, oral. Standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters and diuretics as needed.
Sponsors
Shanghai University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Functional Grading | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasonic cardiogram | 12 weeks | 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 '). |
| 6-min walking test (6mwt) | 12 weeks | 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. |
| Minnesota Heart Failure Quality of Life Scale | 12 weeks | 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. |
| N-terminal pro-B-type natriuretic peptide（NT-proBNP） | 12 weeks | NT-proBNP is a reliable and sensitive indicator of heart failure. Its elevation is positively correlated with severity of heart failure. |
| TCM syndrome score | 12 weeks | 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. |
Countries
China
Contacts
Primary ContactBing Deng, M.D
Backup ContactNa Zhang, M.D
Outcome results
None listed