Efficacy and Safety of Jia Shen Tablets in Chronic Heart Failure

Official title

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)

Overview

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

Interventions

• 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
• 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
• 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

Primary outcome measures

• 6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 12. [Time frame: Baseline and Week 12.]

Secondary outcome measures (9)

• 6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 6. [Time frame: Baseline and Week 6.]
• NT-proBNP: the change from baseline to Week 6 and 12. [Time frame: Baseline, Week 6 and 12.]
• NT-proBNP: the proportion of patients demonstrating a decrease in NT-proBNP level of at least 30%. [Time frame: 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). [Time frame: 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. [Time frame: Baseline, Week 6 and 12.]
• MLHFQ Score: the change from baseline to Week 6 and 12. [Time frame: Baseline, Week 6 and 12.]
• Traditional Chinese Medicine（TCM） Syndrome Score: change from baseline to Week 6 and 12. [Time frame: 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. [Time frame: 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）. [Time frame: Week 12.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Tianjin University of traditional Chinese — Tianjin

Identifiers

NCT: NCT06669169 · TSL-TCM-JSP-Ⅱ

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗