SHengXIaN-QuYu DEcoction in Heart Failure With Reduced and Mildly Reduced Ejection Fraction

NCT05583773 | Recruiting Phase 4 DMC

• 1 other identifier: 2022-NHLHCRF-LX-02-0102
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 26

Brief Summary

The purpose of this study is to conduct a multicenter, randomized clinical trial to evaluate the effect of "ShengXian-QuYu Decoction" on quality of life , symptoms, and biomarkers in heart failure patients with reduced and mildly reduced ejection fraction.

Conditions

Heart Failure

Keywords

ShengXian-QuYu Decoction; Heart failure with reduced ejection fraction; Heart failure with mildly reduced ejection fraction; Quality of life

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the KCCQ Clinical Summary Score

  KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.

  Up to 12 weeks

Secondary Outcomes (9)

• Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)

  Up to 12 weeks

• Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance

  Up to 12 weeks

• Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)

  Up to 12 weeks

• Change in Left Ventricular Systolic Function

  Up to 12 weeks

• Change in Left Ventricular End-Diastolic Diameter

  Up to 12 weeks

Other Outcomes (8)

• Subjects Included in the Composite Endpoint of Cardiovascular Death and Worsening Heart Failure

  Up to 12 weeks

• Subjects Included in the Composite Endpoint of Cardiovascular Death and Worsening Heart Failure

  Up to 26 weeks

• Renal Composite Endpoint

  Up to 12 weeks

Study Arms (2)

ShengXian-QuYu Decoction

ACTIVE COMPARATOR

Patients will be randomized 1:1 to either ShengXian-QuYu Decoction or placebo. "ShengXian-QuYu Decoction" (calculated by a medicine): 30g of Astragalus membranaceus (Huangqi), 12g of Cornus officinalis (Shanzhuyu), 9g of Panax ginseng (Hongshen), 12g of Anemarrhena asphodeloides (Zhimu), 8g of Cimicifuga foetida (Shengma), 8g of Bupleurum chinense (Chaihu), 10g of Platycodon grandiflorum (Jiegeng), 10g of Sparganium stoloniferum (Sanleng), 9g of Curcuma phaeocaulis (Ezhu), 3g of Whitmania pigra (Shuizhi).

Drug: ShengXian-QuYu Decoction

placebo

PLACEBO COMPARATOR

Placebo matching ShengXian-QuYu Decoction

Other: Placebo

Interventions

ShengXian-QuYu Decoction DRUG

Specification: 30ml/bag, given twice daily, per oral use.

ShengXian-QuYu Decoction

Placebo OTHER

Placebo matching ShengXian-QuYu Decoction, 30ml/bag, given twice daily, per oral use.

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥18 years at the time of consent.
• Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV).
• LVEF \<50%.
• NT-proBNP \>600 pg/ml or BNP ≥150 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP ≥400 pg/ml or BNP ≥100 pg/ml) at enrolment.
• Provision of signed informed consent prior to any study specific procedures.

You may not qualify if:

• Current acute decompensated HF or hospitalization due to decompensated HF, ACS, stroke or transient ischemic attack (TIA), coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\]) or valvular repair/replacement, or other major cardiovascular surgery within 4 weeks prior to enrolment.
• Uncontrolled severe arrhythmia.
• Planned to undergo heart transplantation or device implantation.
• Hepatic impairment aspartate transaminase \[AST\] or alanine transaminase \[ALT\] \>3x the upper limit of normal \[ULN\]; or total bilirubin \>2x ULN at time of enrolment).
• Severe infection.
• eGFR \<30 mL/min/1.73 m\^2 by CKD-EPI.
• Active malignancy requiring treatment at the time of visit 1.
• Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding.
• Any condition outside the CV and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 1 years based on investigator's clinical judgement.
• Systolic blood pressure \< 90 mmHg, or systolic blood pressure ≥ 180 mmHg, or diastolic blood pressure ≥ 110 mmHg on 2 consecutive measurements.
• Heart failure due to infiltrative cardiomyopathies(cardiac amyloidosis, etc.), fulminant myocarditis, constrictive pericarditis.
• Participation in another clinical study.
• Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (26)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Beijing Fengtai Hospital of Integrated Traditional Chinese and Western Medicine

Beijing, Beijing Municipality, 100072, China

RECRUITING

Dongcheng District First People's Hospital

Beijing, Beijing Municipality, 100077, China

RECRUITING

Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100078, China

RECRUITING

Huairou District Traditional Chinese Medicine Hospital of Beijing

Beijing, Beijing Municipality, 101400, China

RECRUITING

Beijing Changping Nankou Hospital

Beijing, Beijing Municipality, 102202, China

RECRUITING

Changping District Traditional Chinese Medicine Hospital

Beijing, Beijing Municipality, 102208, China

RECRUITING

Tang County Hospital of Traditional Chinese Medicine

Baoding, Hebei, 072350, China

RECRUITING

Funing Hospital of Traditional Chinese Medicine

Qinhuangdao, Hebei, 066399, China

RECRUITING

Gongyi City Public Hospital of TCM

Gongyi, Henan, 451200, China

RECRUITING

Yangzhou Hospital of Traditional Chinese Medicine

Yangzhou, Jiangsu, 225127, China

RECRUITING

Jining Hospital of Traditional Chinese Medicine

Jining, Shandong, 272004, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266071, China

RECRUITING

The Affiliated Hospital of Changzhi Institute of Traditional Chinese Medicine

Changzhi, Shanxi, 046000, China

RECRUITING

Changzhi Medical College Affiliated Heji Hospital

Changzhi, Shanxi, 046011, China

RECRUITING

Changzhi Hospital of Traditional Chinese Medicine

Changzhi, Shanxi, 046099, China

RECRUITING

Chengdu Integrated TCM and Western Medicine Hospital

Chengdu, Sichuan, 610095, China

RECRUITING

Jixian Chinese Traditional Hospital

Tianjin, Tianjin Municipality, 301900, China

RECRUITING

Urumqi Hospital of Traditional Chinese Medicine

Ürümqi, Xinjiang, 830000, China

RECRUITING

Korla Hospital of Traditional Chinese Medicine

Bayan Gol Autonomous Prefecture, Xinjiang Uygur Autonomous Region, 841009, China

RECRUITING

Changji Hospital of Traditional Chinese Medicine

Changji Hui Autonomous Prefecture, Xinjiang Uygur Autonomous Region, 831199, China

RECRUITING

Gulja Hospital of Traditional Chinese Medicine

Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region, 835199, China

RECRUITING

Zhaosu Hospital of Traditional Chinese Medicine

Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region, 835699, China

RECRUITING

Xinyuan Traditional Chinese Medicine Hospital

Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region, 835899, China

RECRUITING

Linhai Hospital of Traditional Chinese Medicine

Linhai, Zhejiang, 317000, China

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Mengxi Yang, Dr.

CONTACT

+86 15120049452; mxtezuka@163.com

Jiang Liu, Dr.

CONTACT

+86 19800361320; yzliujiang@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 18, 2022
• Study Start: March 29, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (26)