Efficacy and Safety of Jia Shen Tablets in Chronic Heart Failure

A Randomized, Placebo-Controlled, Double-Blind and Multi-Centre Phase II Clinical Trial：Efficacy and Safety of Jia Shen Tablets in the Treatment of Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Yang Qi Deficiency With Blood Stasis)

Evaluate the efficacy and safety of Jia Shen Tablets in patients with Chronic Heart Failure.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Jia Shen Tablet Placebo; Drug: Low dose Jia Shen Tablet; Drug: High dose Jia Shen Tablet

• Study Type: Interventional
• Enrollment (Estimated): 288
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rui Liu; Phone Number: 022-86343626; Email: liurui2@tasly.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • The First Affiliated Hospital of Tianjin University of traditional Chinese
      • Contact: Jingyuan Mao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 40-79 years, either sex;
• Meet the diagnostic criteria for CHD and CHF;
• Meet the TCM differentiation criteria of yang qi deficiency and blood stasis in CHF;
• Class Ⅱ to Ⅲ for NYHA functional classification;
• Willing to provide written informed consent.

Exclusion Criteria:

• CHF with acute exacerbation or intravenous drug therapy;
• Received cardiac resynchronization therapy (CRT) or other heart failure devices;
• Within 3 months before randomization, acute coronary syndrome（ACS）, stroke or transient ischemic attack（TIA） occurred or received cardiac revascularization (PCI, CABG);
• Plan to undergo cardiac revascularization (PCI, CABG) or cardiac resynchronization therapy (CRT) during the trial period;
• Severe arrhythmias [such as persistent atrial fibrillation, permanent atrial fibrillation, ventricular tachycardia, second-degree type II or higher sinus or atrioventricular block without pacemaker placement, QT interval (QTc) exceeding 480 ms after heart rate adjustment according to Fridericia's formula, or known history or symptoms of long QT syndrome];
• Severe hypertension (systolic blood pressure ≥180mm Hg or diastolic blood pressure ≥110mm Hg) or hypotension (systolic blood pressure < 90 mmHg);
• Heart failure caused by other cardiovascular diseases such as congenital heart disease, severe stenosis or insufficiency of heart valves, cardiomyopathy (e.g. hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy), moderate pericardial effusion, constrictive pericarditis, and infective endocarditis;
• Combined with liver, kidney, hematopoietic system and other serious primary diseases, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3 times the upper limit of local laboratory normal value, the estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2, Blood potassium > 5.5 mmol/L or hemoglobin (Hb) < 90 g/L; Malignant tumors, severe neuroendocrine system diseases and mental diseases;
• Pregnant or lactating;
• Participating in other interventional clinical studies within 1 month before screening;
• Allergic constitution, or allergic to Chinese medicines of Jia Shen Tablets (such as Periploca sepium, salvia miltiorrhiza, etc.);
• The investigator determines that the patient is unable to complete the study or comply with the requirements of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Drug: Jia Shen Tablet Placebo; Jia Shen Tablet Placebo contains 4 placebo tablets (0.47 g per placebo tablet),take orally, 2 times a day for 12 weeks
Experimental: Low dose group	Drug: Low dose Jia Shen Tablet; Low dose Jia Shen Tablet contains 2 tablets (0.47 g per tablet) and 2 placebo tablets (0.47 g per placebo tablet),take orally, 2 times a day for 12 weeks
Experimental: High dose group	Drug: High dose Jia Shen Tablet; High dose Jia Shen Tablet contains 4 tablets (0.47 g per tablet),take orally, 2 times a day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 12.	Baseline and Week 12.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 6.		Baseline and Week 6.
NT-proBNP: the change from baseline to Week 6 and 12.		Baseline, Week 6 and 12.
NT-proBNP: the proportion of patients demonstrating a decrease in NT-proBNP level of at least 30%.		Baseline, Week 6 and 12.
Echocardiogram: Measurements will be made of the left ventricle's end diastolic diameter (LVEDD), end diastolic volume (LVEDV), end systolic volume (LVESV), left ventricular ejection fraction（LVEF）, stroke volume (SV), and cardiac output (CO).		Baseline and Week 12.
NYHA functional classification: Measure the percentage of participants whose NYHA functional classification is improved/worsened/unchanged from baseline to Week 6 and 12.		Baseline, Week 6 and 12.
MLHFQ Score: the change from baseline to Week 6 and 12.	The MLHFQ consists of 21 elements representing varying degrees of impact of HF on health related quality of life. Each item in this questionnaire is scored from 0 (none) to 5 (very much), and the total item score is from 0 (none) to 105 (very much).	Baseline, Week 6 and 12.
Traditional Chinese Medicine（TCM） Syndrome Score: change from baseline to Week 6 and 12.	There were 3 primary symptoms and 4 secondary symptoms. The state of the tongue and pulse is used to evaluate and score TCM symptoms. The standard of TCM primary symptoms scored as without 0, light 2, medium 4, heavy 6 points. The standard of TCM secondary symptoms scored as without 0, light 1, medium 2, heavy 3 points. Tongue picture and pulse condition did not count.	Baseline, Week 6 and 12.
Dyspnea, weakness and edema: the rate of disappearance of the symptoms (dyspnea, weakness, and edema) from baseline to Week 6 and 12.		Baseline, Week 6 and 12.
Cardiovascular Adverse Events: Incidence of Cardiovascular AEs（cardiovascular death, hospitalization for worsening heart failure, hospitalization for nonfatal myocardial infarction, hospitalization for nonfatal stroke）.		Week 12.

Collaborators and Investigators

• Sponsor: Tasly Pharmaceutical Group Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: TSL-TCM-JSP-Ⅱ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No