Efficacy and Safety of Jia Shen Tablets in Chronic Heart Failure

NCT06669169 | Not Yet Recruiting Phase 2

• 1 other identifier: TSL-TCM-JSP-Ⅱ
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 12.

  Baseline and Week 12.

Secondary Outcomes (9)

• 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.

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Drug: Jia Shen Tablet Placebo

Low dose group

EXPERIMENTAL

Drug: Low dose Jia Shen Tablet

High dose group

EXPERIMENTAL

Drug: High dose Jia Shen Tablet

Interventions

Jia Shen Tablet Placebo DRUG

Jia Shen Tablet Placebo contains 4 placebo tablets (0.47 g per placebo tablet),take orally, 2 times a day for 12 weeks

Placebo group

Low dose Jia Shen Tablet DRUG

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

Low dose group

High dose Jia Shen Tablet DRUG

High dose Jia Shen Tablet contains 4 tablets (0.47 g per tablet),take orally, 2 times a day for 12 weeks

High dose group

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Tianjin University of traditional Chinese

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Rui Liu

CONTACT

022-86343626; liurui2@tasly.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: January 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

CN (1)