The Relationship Between XinKang-I and Chronic Heart Failure

NCT05847959 | Unknown

• 1 other identifier: DongguanHTCM
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Heart failure is the severe and terminal stage of various heart diseases, which is characterized by high morbidity, mortality and readmission. There are few studies on the relationship between XinKang-I(XK-I) and chronic heart failure. Objective: To explore the relationship between XK-I and chronic heart failure. Methods/design: The trial is a single-center, single-blind, randomized study (1:1). It will recruit 110 patients with chronic heart failure who syndrome of qi deficiency yang deficiency and blood stasis. The intervention group will receive not only Western medicine, but also XK-I. The primary end points will be the changes in oxygen consumption volume of anaerobic threshold (VO2AT), maximum oxygen volume uptake (VO2max), and 6-minute walking distance after 8 weeks of treatment. Both groups will receive 8 weeks of treatment. Ethics and dissemination: Ethical approval was granted by Ethics Committee of Dongguan TCM Hospital. Results will be disseminated via peer-reviewed publications and presentations at international conferences.

Conditions

Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (3)

• The changes in 6-minute walking distance(distance, meter).

  Cardiac function

  8 weeks

• oxygen consumption volume of anaerobic threshold (VO2AT, ml)

  Cardiac function

  8 weeks

• maximum oxygen volume uptake (VO2max, ml/min) in cardiopulmonary function test

  Cardiac function

  8 weeks

Study Arms (2)

intervention group

ACTIVE COMPARATOR

The intervention group will receive not only Western medicine, but also XK-I. The therapeutic drugs used in the control group will be according to the European Society of Cardiology's 2021 guidelines for the diagnosis and treatment of acute and chronic heart failure.

Drug: Traditional Chinese medicine prescription：XinKang-I

The control group

NO INTERVENTION

The control group will receive Western medicine.The therapeutic drugs used in the control group will be according to the European Society of Cardiology's 2021 guidelines for the diagnosis and treatment of acute and chronic heart failure.

Interventions

Traditional Chinese medicine prescription：XinKang-I DRUG

XK-I will be used in intervention group (20 grams of radix astragalus, 20 grams of radix codonopsis, 10 grams of stir-fried semen lepidii, 8 grams of sweet apricot kernel, 10 grams of cassia twig, 15 grams of poria cocos, 10 grams of atractylodes, 5 grams of honey-roasted licorice, 15 grams of radix et rhizoma salviae miltiorrhizae, 10 grams of chuanxiong rhizoma, 5 grams of tangerine peel).Patients will take XK-I once a day, divided into morning and evening administration. The treatment lasted for 8 weeks.

intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of CHF or clinical findings of CHF for more than 3 months. CHF was diagnosed in accordance with the European Society of Cardiology's 2021 Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure.
• Patients ranged in age from 18 to 85.
• Cardiac function was graded at grade II-IV (New York Heart Association functional class).
• Patients who had not used traditional Chinese medicine for treating heart failure within 1 week before enrollment;
• Written informed consent will be obtained.

You may not qualify if:

• acute cardiac insufficiency, acute myocarditis, severe valvular heart disease, malignant arrhythmia, obstructive cardiomyopathy, pericardial tamponade, constrictive pericarditis or acute coronary syndrome
• severe lung, liver or kidney dysfunction
• nervous and hematopoietic system
• malignant tumors
• hemodynamic nstability
• pulmonary embolism
• severe infection
• pregnant or lactating
• refusal to provide written informed consent for this study

Sponsors & Collaborators

• Dongguan Hospital of Traditional Chinese Medicine: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiology

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 8, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 8, 2023

Record last verified: 2023-04