The Relationship Between XinKang-I and Chronic Heart Failure

The Relationship Between XinKang-I and Chronic Heart Failure: Protocol for a Randomized Controlled Study.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Traditional Chinese Medicine
• Intervention / Treatment: Drug: Traditional Chinese medicine prescription：XinKang-I

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. 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.
2. Patients ranged in age from 18 to 85.
3. Cardiac function was graded at grade II-IV (New York Heart Association functional class).
4. Patients who had not used traditional Chinese medicine for treating heart failure within 1 week before enrollment;
5. Written informed consent will be obtained.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intervention group; 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; 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.
No Intervention: The control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dongguan Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: DongguanHTCM

Drug and device information, study documents

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