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The Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency (HFpEF)

Primary Purpose

Heart Failure With Preserved Ejection Fraction

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Zhigancao Tang granule
Zhigancao Tang placebo granule
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction focused on measuring heart failure with preserved ejection fraction, Qi-Yin deficiency syndrome, randomized, double blinded and controlled trial, Zhigancao Tang granule

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Comply with the diagnostic criteria of Western medicine for HFpEF and the diagnostic criteria for TCM syndromes of Qi-Yin deficiency;
  2. Cardiac function classification by NYHA: grade I to III;
  3. Age between 30 and 80 years old;
  4. Those who volunteer to participate in clinical trial observation, sign informed consent and indicate date;
  5. During the observation period, those who do not take other drugs other than those specified and can insist on completing the treatment and observation.

Exclusion Criteria:

  1. Valvular heart disease, restrictive cardiomyopathy, pericardial disease;
  2. Decompensated heart failure is unstable after treatment;
  3. Combined with atrial fibrillation;
  4. Patients with severe lung, liver, endocrine system and kidney dysfunction;
  5. Patients with cancer and other common malignant diseases reducing life expectancy;
  6. Pregnant or lactating women;
  7. Allergic constitution or allergic history to common drugs;
  8. Patients with mental illness or poor compliance of traditional Chinese medicine treatment.

Sites / Locations

  • Longhua Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zhigancao Tang granule group

Zhigancao Tang placebo group

Arm Description

Participants in experimental group will receive Zhigancao Tang granule therapy for 12 weeks. In addition, participants will receive standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters, diuretics as needed.

Participants in experimental group will receive Zhigancao Tang placebo granule therapy for 12 weeks. In addition, participants will receive standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters and diuretics as needed.

Outcomes

Primary Outcome Measures

Cardiac Functional Grading
Significant effect: cardiac function recovered to level 1 or increased by level 2; Effective: cardiac function increased by level 1 but failed to reach level 2; Ineffective: cardiac function did not change; Worsening: cardiac function decreased by level 1 or above.

Secondary Outcome Measures

Ultrasonic cardiogram
Echocardiographic measurement of Left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDd), left ventricular end systolic diameter (LVESD), ratio of left ventricular early diastolic fast filling peak to late diastolic filling peak (E / a), ratio of early diastolic velocity of mitral valve to early diastolic annular velocity (E / E ').
6-min walking test (6mwt)
6 minute walking test (6mwt) is a measure of the distance the patient can reach as far as possible by walking on a hard ground without obstacles within six minutes at the fastest possible speed. It provides a comprehensive assessment of exercise capacity.
Minnesota Heart Failure Quality of Life Scale
Minnesota Heart Failure Quality of Life Scale was used to assess the impact of heart failure on life in the last four weeks. A total of 21 questions related to physical and emotional change. Higher scores mean a worse outcome.
N-terminal pro-B-type natriuretic peptide（NT-proBNP）
NT-proBNP is a reliable and sensitive indicator of heart failure. Its elevation is positively correlated with severity of heart failure.
TCM syndrome score
TCM syndrome score is used to assess changes in Qi-Yin Dificiency related symptoms during treatment. The higher the scores, the more heart failure symptoms. Higher scores mean a worse outcome.

Full Information

First Posted
March 4, 2020
Last Updated
March 19, 2020
Sponsor
Shanghai University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04317339
Brief Title
The Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency
Acronym
HFpEF
Official Title
A Randomized，Double-blinded, Placebo-controlled Trial Evaluating the Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2020 (Anticipated)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study was designed as a randomized, double blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the efficacy and safety of Zhigancao Tang granule in patients with HFpEF of Qi-Yin dificiency.
Detailed Description
Heart failure with preserved ejection fraction (HFPEF) is a clinical syndrome characterized by diastolic dysfunction.The incidence of HFpEF is increasing in recent years. Standard treatment of heart failure does not improve the prognosis of HFPEF patients. Zhigancao Tang was used to improve the symptoms of chronic heart failure in China.This randomized,double-blinded and placebo-controlled trial will objectively and standardly evaluate the effectiveness and safety of Zhigancao Tang granule.After 12 weeks of treatment, 122 HFpEF patients with deficiency of Qi and Yin were observed and evaluated in terms of heart function, clinical symptoms,exercise tolerance and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction
Keywords
heart failure with preserved ejection fraction, Qi-Yin deficiency syndrome, randomized, double blinded and controlled trial, Zhigancao Tang granule

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zhigancao Tang granule group
Arm Type
Experimental
Arm Description
Participants in experimental group will receive Zhigancao Tang granule therapy for 12 weeks. In addition, participants will receive standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters, diuretics as needed.
Arm Title
Zhigancao Tang placebo group
Arm Type
Placebo Comparator
Arm Description
Participants in experimental group will receive Zhigancao Tang placebo granule therapy for 12 weeks. In addition, participants will receive standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters and diuretics as needed.
Intervention Type
Drug
Intervention Name(s)
Zhigancao Tang granule
Other Intervention Name(s)
Zhigancao Tang group, Zhigancao Tang granule group
Intervention Description
Zhigancao Tang: Dissolve Zhigancao Tang granule in 200ml hot water, twice a day,12 weeks, oral. Standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters and diuretics as needed.
Intervention Type
Drug
Intervention Name(s)
Zhigancao Tang placebo granule
Other Intervention Name(s)
Zhigancao Tang placebo group, Zhigancao Tang placebo granule group
Intervention Description
Zhigancao Tang placebo: Dissolve Zhigancao Tang placebo granule in 200ml hot water, twice a day,12 weeks, oral. Standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters and diuretics as needed.
Primary Outcome Measure Information:
Title
Cardiac Functional Grading
Description
Significant effect: cardiac function recovered to level 1 or increased by level 2; Effective: cardiac function increased by level 1 but failed to reach level 2; Ineffective: cardiac function did not change; Worsening: cardiac function decreased by level 1 or above.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Ultrasonic cardiogram
Description
Echocardiographic measurement of Left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDd), left ventricular end systolic diameter (LVESD), ratio of left ventricular early diastolic fast filling peak to late diastolic filling peak (E / a), ratio of early diastolic velocity of mitral valve to early diastolic annular velocity (E / E ').
Time Frame
12 weeks
Title
6-min walking test (6mwt)
Description
6 minute walking test (6mwt) is a measure of the distance the patient can reach as far as possible by walking on a hard ground without obstacles within six minutes at the fastest possible speed. It provides a comprehensive assessment of exercise capacity.
Time Frame
12 weeks
Title
Minnesota Heart Failure Quality of Life Scale
Description
Minnesota Heart Failure Quality of Life Scale was used to assess the impact of heart failure on life in the last four weeks. A total of 21 questions related to physical and emotional change. Higher scores mean a worse outcome.
Time Frame
12 weeks
Title
N-terminal pro-B-type natriuretic peptide（NT-proBNP）
Description
NT-proBNP is a reliable and sensitive indicator of heart failure. Its elevation is positively correlated with severity of heart failure.
Time Frame
12 weeks
Title
TCM syndrome score
Description
TCM syndrome score is used to assess changes in Qi-Yin Dificiency related symptoms during treatment. The higher the scores, the more heart failure symptoms. Higher scores mean a worse outcome.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Comply with the diagnostic criteria of Western medicine for HFpEF and the diagnostic criteria for TCM syndromes of Qi-Yin deficiency; Cardiac function classification by NYHA: grade I to III; Age between 30 and 80 years old; Those who volunteer to participate in clinical trial observation, sign informed consent and indicate date; During the observation period, those who do not take other drugs other than those specified and can insist on completing the treatment and observation. Exclusion Criteria: Valvular heart disease, restrictive cardiomyopathy, pericardial disease; Decompensated heart failure is unstable after treatment; Combined with atrial fibrillation; Patients with severe lung, liver, endocrine system and kidney dysfunction; Patients with cancer and other common malignant diseases reducing life expectancy; Pregnant or lactating women; Allergic constitution or allergic history to common drugs; Patients with mental illness or poor compliance of traditional Chinese medicine treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bing Deng, M.D
Phone
8618917763110
Email
dengbing82@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Na Zhang, M.D
Phone
8613817980876
Email
lhzhna@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Deng, M.D
Organizational Affiliation
Shanghai Longhua Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Longhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Deng, M.D
Phone
8618917763110
Email
dengbing82@sina.com
First Name & Middle Initial & Last Name & Degree
Na Zhang, M.D
Phone
8613817980876
Email
lhzhna@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33879223
Citation
Zhang N, Zhao Y, Liu Y, Tang N, Zheng W, Mao M, Liu Q, Shen L, Deng B. A double-blinded, placebo-controlled randomized trial evaluating the efficacy and safety of Zhigancao Tang granules for treating HFpEF: study protocol for a randomized controlled trial. Trials. 2021 Apr 20;22(1):293. doi: 10.1186/s13063-021-05232-6.
Results Reference
derived

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The Efficacy and Safety of Zhigancao Tang Granule for HFpEF of Qi-Yin Dificiency

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