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A randomized controlled, double-blind, placebo, multicenter clinical study of Chinese medicine intervention in the treatment of ejection fraction preserved heart failure

A randomized controlled, double-blind, placebo, multicenter clinical study of Chinese medicine intervention in the treatment of ejection fraction preserved heart failure guided by the theory of "heart and kidney treatment"

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082425
Enrollment
Unknown
Registered
2024-03-28
Start date
2024-03-31
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Interventions

Treatment group:Standard treatment combination with oral Yiqi Huayu decoction granules orally, two bags a day, twice a day, 200ml of water
control group:Standard treatment combined with oral Yiqi Huayu decoction granule simulator, two bags a day, twice a day, 200ml water
Treatment group:Standard treatment combination with oral qiang xin decoction granules orally, two bags a day, twice a day, 200ml of water
control group:Standard treatment combination with oral qiang xin decoction granules simulator, two bags a day, twice a day, 200ml of water
Treatment group:Standard treatment combination with oral ziyin yangshen decoction granules orally, two bags a day, twice a day, 200ml of water
control group:Standard treatment combination with oral ziyin yangshen decoction granules simulator, two bags a day, twice a day, 200ml of water

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: At the same time, it meets the diagnostic criteria of Western medicine and Chinese medicine for the heart failure with ejection fraction preservation. Age 40 ~ 80 years old; The patient has complete basic information, can adhere to medication, and has follow-up conditions; Patients and their families were aware of the purpose of the study, signed informed consent, and voluntarily participated in the study.

Exclusion criteria

Exclusion criteria: Concomitant with restrictive (invasive) cardiomyopathy and congenital heart disease Acute coronary syndrome History of stent implantation, coronary artery bypass, permanent pacemaker implantation, and implantable defibrillator implantation within the last 90 days (from the time of admission); eGFR=20ml/min/1.73 m2, severe liver insufficiency Complicated with malignant tumor, hematopoietic system disease, acute infectious disease Urine pregnancy positive, breastfeeding or pregnant women Patients suffering from mental illness or infectious diseases

Design outcomes

Primary

MeasureTime frame
Re-hospitalization or cardiovascular mortality due to worsening heart failure at 180 days;

Secondary

MeasureTime frame
180-day all-cause mortality;NT-proBNP;echocardiography;electrocardiogram;Plasma transcriptomics;Metabolomics of plasma;Minnesota Heart Failure Questionnaire score;Kansas City heart muscle scale;TCM syndrome score;Lipid set;6 minutes walking test;H2FPEF score;

Countries

china

Contacts

Public ContactXiaolong Wang

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

wxlqy0214@163.com+86 135 0199 1450

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026