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Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure

Primary Purpose

Heart Failure, Cardiovascular Diseases

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Qishen Granules

Placebo

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring chronic heart failure, traditional Chinese medicine, Qishen granules

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age between 18 and 75 years;
clinical findings of CHF for at least 3 months prior to screening;
CHF caused by coronary heart disease and hypertension, which is diagnosed according to the Chinese guidelines published in 2014 for the diagnosis and management of CHF;
clinically stable condition with an NYHA functional class of II to III and an optimal medical treatment with a fixed dosage for at least 2 weeks;
a documented left ventricular ejection fraction (LVEF) ≤40% and a serum NT-proBNP level ≥450 pg/ml;
CHF of Qi deficiency and blood stasis syndrome;
provision of written informed consent.

Exclusion Criteria:

CHF complicated with severe valvular disease, congenital heart disease, pericardial disease, cardiomyopathy, unstable angina, acute myocardial infarction(in recent 4 weeks), cardiogenic shock, acute myocarditis, infective endocarditis, uncontrolled severe cardiac arrhythmia with hemodynamic changes;
pulmonary heart disease, pulmonary hypertension caused by acute or chronic pulmonary embolism or cerebral apoplexy in recent 6 months;
severe hepatic inadequacy with alanine aminotransferase or alkaline phosphatase levels >2 times the upper normal limit, renal inadequacy with a creatinine clearance rate>20% or a serum creatinine level>3mg/dl (>265μmol/L), severe electrolyte imbalance, severe hematologic disease, malignant tumor, diabetes mellitus with severe complications, or severe endocrine diseases such as hyperthyroidism and hypothyroidism;
acute infection confirmed by any one of the following 3 tips: 1) fever; 2) a white blood cell count>10×109/L and a percentage of neutrophils>85%; 3) shadows on chest X-ray;
uncontrolled blood pressure or fibrosis in other organs;
CHF of yin deficiency according to TCM syndrome differentiation;
pregnancy or breastfeeding;
psychiatric or infectious disease;
patients who have participated in other clinical trials in the past two months.

Sites / Locations

China-Japan Friendship HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Qishen granules

placebo granules

Arm Description

The QSG treatment group will receive Qishen granules (13.6 g/pouch, twice per day-30 minutes after breakfast and dinner-for 12 weeks; dosage based on the requirements of Pharmacopoeia of the People's Republic of China).

The placebo group will receive placebo granules (13.6 g/pouch, twice per day-30 minutes after breakfast and dinner-for 12 weeks).

Outcomes

Primary Outcome Measures

the reduction or percent change in the plasma N-terminal pro-B-type natriuretic peptide

Secondary Outcome Measures

composite cardiac events

New York Heart Association (NYHA) functional classification

6-minute walking distance

Left ventricular ejection fraction

Chronic Heart Failure Quality of Life Scale of Integrated Chinese and Western Medicine

TCM syndrome integral scale

Full Information

NCT ID

NCT03027375

First Posted

January 16, 2017

Last Updated

October 6, 2017

Sponsor

Beijing University of Chinese Medicine

Collaborators

China-Japan Friendship Hospital, Zhengzhou Hospital of Traditional Chinese Medicine, Beijing Anzhen Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03027375

Brief Title

Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure

Official Title

Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure: Study Protocol for a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 31, 2017 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing University of Chinese Medicine

Collaborators

China-Japan Friendship Hospital, Zhengzhou Hospital of Traditional Chinese Medicine, Beijing Anzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This trial will assess the efficacy and safety of QSG in CHF.

Detailed Description

Background: Chronic heart failure(CHF), the final stage of various cardiovascular diseases, is a major public health problem associated with significant hospitalization rates, mortality, and huge health care costs, despite advances in the treatment and management of heart failure and heart failure related risk factors. Qishen granules(QSG), a Chinese herbal formula, is widely used by traditional chinese medicine(TCM) practitioners to treat CHF. Several animal experimental studies have showed that QSG can significantly relieve the heart failure symptoms of CHF rat models. However, there is yet no standard clinical trial to assess that. Thus, the investigators are conducting this study to evaluate the efficacy and safety of QSG in a large, varied population. Methods/Design: This study is designed as a randomized, multi-center, placebo-controlled, double-blind , parallel-group clinical trial. An established total of 200 patients with CHF will be recruited and randomly allocated to either the QSG treatment group or the placebo group (a 1:1 ratio). The patients will receive QSG or placebo granules twice daily for 12 weeks. The primary endpoint is the reduction or percent change in the plasma N-terminal pro-B-type natriuretic peptide(NT-proBNP) level during 12 weeks of treatment. The secondary endpoints consist of composite cardiac events (CCEs), New York Heart Association (NYHA) functional classification, 6-minute walking distance (6MWD), Left ventricular ejection fraction, patient quality of life and TCM syndrome integral scale. Discussion: This trial will assess the efficacy and safety of QSG in CHF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Cardiovascular Diseases

Keywords

chronic heart failure, traditional Chinese medicine, Qishen granules

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Qishen granules

Arm Type

Experimental

Arm Description

Arm Title

placebo granules

Arm Type

Placebo Comparator

Arm Description

The placebo group will receive placebo granules (13.6 g/pouch, twice per day-30 minutes after breakfast and dinner-for 12 weeks).

Intervention Type

Drug

Intervention Name(s)

Qishen Granules

Other Intervention Name(s)

Yixin Jiedu formula

Intervention Description

The QSG are manufactured by Beijing tcmages Pharmaceutical Co., Ltd. (Beijing, China), a company that has obtained Chinese Good Manufacturing Practice for Pharmaceutical Products certification. All the ingredients have been approved by the Chinese Ministry of Food and Drug Safety. 13.6 grams (dry weight) of granules consist of six herbs: Astragalus membranaceus (Fisch.) Bge. var. Mongolicus (Bge.) Hsiao (6g), Salvia miltiorrhiza Bge. (1.5g), Lonicera japonica Thunb. (2g), Scrophularia ningpoensis Hemsl. (2g), Aconitum carmichaeli Debx. (0.9g), and Glycyrrhiza uralensis Fisch. (1.2g).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

The placebo is manufactured by Beijing tcmages Pharmaceutical Co., Ltd. (Beijing, China) as well, following the Specification for processing Chinese medicine in Beijing. The placebo granules are similar in appearance, taste, and scent to the Qishen granules.

Primary Outcome Measure Information:

Title

the reduction or percent change in the plasma N-terminal pro-B-type natriuretic peptide

Time Frame

12weeks

Secondary Outcome Measure Information:

Title

composite cardiac events

Time Frame

4weeks,8weeks,12weeks

Title

New York Heart Association (NYHA) functional classification

Time Frame

4weeks,8weeks,12weeks

Title

6-minute walking distance

Time Frame

4weeks,8weeks,12weeks

Title

Left ventricular ejection fraction

Time Frame

12weeks

Title

Chronic Heart Failure Quality of Life Scale of Integrated Chinese and Western Medicine

Time Frame

4weeks,8weeks,12weeks

Title

TCM syndrome integral scale

Time Frame

4weeks,8weeks,12weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age between 18 and 75 years; clinical findings of CHF for at least 3 months prior to screening; CHF caused by coronary heart disease and hypertension, which is diagnosed according to the Chinese guidelines published in 2014 for the diagnosis and management of CHF; clinically stable condition with an NYHA functional class of II to III and an optimal medical treatment with a fixed dosage for at least 2 weeks; a documented left ventricular ejection fraction (LVEF) ≤40% and a serum NT-proBNP level ≥450 pg/ml; CHF of Qi deficiency and blood stasis syndrome; provision of written informed consent. Exclusion Criteria: CHF complicated with severe valvular disease, congenital heart disease, pericardial disease, cardiomyopathy, unstable angina, acute myocardial infarction(in recent 4 weeks), cardiogenic shock, acute myocarditis, infective endocarditis, uncontrolled severe cardiac arrhythmia with hemodynamic changes; pulmonary heart disease, pulmonary hypertension caused by acute or chronic pulmonary embolism or cerebral apoplexy in recent 6 months; severe hepatic inadequacy with alanine aminotransferase or alkaline phosphatase levels >2 times the upper normal limit, renal inadequacy with a creatinine clearance rate>20% or a serum creatinine level>3mg/dl (>265μmol/L), severe electrolyte imbalance, severe hematologic disease, malignant tumor, diabetes mellitus with severe complications, or severe endocrine diseases such as hyperthyroidism and hypothyroidism; acute infection confirmed by any one of the following 3 tips: 1) fever; 2) a white blood cell count>10×109/L and a percentage of neutrophils>85%; 3) shadows on chest X-ray; uncontrolled blood pressure or fibrosis in other organs; CHF of yin deficiency according to TCM syndrome differentiation; pregnancy or breastfeeding; psychiatric or infectious disease; patients who have participated in other clinical trials in the past two months.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jinping Wang, Master

Phone

13810689802

wjpbucm@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Wang, Doctor

Organizational Affiliation

Beijing University of Chinese Medicine

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Huihui Zhao, Doctor

Organizational Affiliation

Beijing University of Chinese Medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jinping Wang, Master

Organizational Affiliation

Beijing University of Chinese Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

China-Japan Friendship Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100029

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jinping Wang, doctor

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23747768

Citation

Li X, Zhang J, Huang J, Ma A, Yang J, Li W, Wu Z, Yao C, Zhang Y, Yao W, Zhang B, Gao R; Efficacy and Safety of Qili Qiangxin Capsules for Chronic Heart Failure Study Group. A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure. J Am Coll Cardiol. 2013 Sep 17;62(12):1065-1072. doi: 10.1016/j.jacc.2013.05.035. Epub 2013 Jun 7.

Results Reference

background

PubMed Identifier

25951678

Citation

General Assembly of the World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent. 2014 Summer;81(3):14-8.

Results Reference

background

PubMed Identifier

11273440

Citation

Switula D. Principles of good clinical practice (GCP) in clinical research. Sci Eng Ethics. 2000 Jan;6(1):71-7. doi: 10.1007/s11948-000-0025-z.

Results Reference

background

PubMed Identifier

26727047

Citation

van Riet EE, Hoes AW, Wagenaar KP, Limburg A, Landman MA, Rutten FH. Epidemiology of heart failure: the prevalence of heart failure and ventricular dysfunction in older adults over time. A systematic review. Eur J Heart Fail. 2016 Mar;18(3):242-52. doi: 10.1002/ejhf.483. Epub 2016 Jan 4.

Results Reference

result

PubMed Identifier

29017565

Citation

Wang J, Shi J, Wei J, Wang J, Gao K, Li X, Chen J, Li S, Zhao H, Wang W. Safety and efficacy of Qishen granules in patients with chronic heart failure: study protocol for a randomized controlled trial. Trials. 2017 Oct 10;18(1):468. doi: 10.1186/s13063-017-2193-z.

Results Reference

derived

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Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure

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