Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules

December 15, 2024 updated by: Lei Wang,MD, Guangdong Provincial Hospital of Traditional Chinese Medicine

A Randomized, Double-blind, Placebo-controlled Study on the Treatment of Heart Failure with Preserved Ejection Fraction with Qishen Granules Based on Cardiopulmonary Exercise Test

With the cardiopulmonary exercise testing as the primary outcome, the study aims to evaluate the efficacy of Qishen Granules on cardiac function, quality of life and biomarker level of patients with heart failure with preserved ejection fraction (HFpEF), which will provide evidence for the treatment of HFpEF with traditional Chinese medicine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Heart failure with preserved ejection fraction (HFpEF) is common and is associated with high morbidity and mor-tality in China. Studies have shown that traditional Chinese medicine (TCM) combined with conventional Western medicine has a good effect on improving exercise tolerance and quality of life in patients with HFpEF, but there are still some shortcomings that limit the reliability and extrapolation of results. Based on TCM theory and our decades of experience, we developed Qishen Granules for therapeutic use in the treatment of HFpEF. The good effect of Qishen Granules in patients with heart failure has been clinically verified before. In this study, cardiopulmonary exercise test (CPET) was used to evaluate the peak oxygen consumption (peak VO2), which is the gold standard assessment of aerobic capacity. Therefore, we selected VO2 peak as the primary outcome. At the same time, we conducted a preliminary assessment of the efficacy of Qishen Granules in improving the quality of life in patients with HFpEF, using Kansas City Cardiomyopathy Questionnaire (KCCQ) as the secondary outcome, and combined with other CPET indicators, echocardiographic measures, NT-pro BNP level, growth STimulation expressed gene 2 (ST2), biomarkers of liver and kidney function, and TCM Four-Dimensional Diagnostic Information Scale (TCMFDIS) to objectively, accurately, and comprehensively evaluate the efficacy and safety of Qishen Granules in improving quality of life and exercise capacity in patients with HFpEF.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangdong Provincial Hospital of Chinese Medicine
        • Contact:
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • WangLei
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Sign the informed consent form
  2. Age 18-85 years old
  3. Heart failure was diagnosed ≥ 3 months before enrollment, The heart function classification II-IV of New York Heart Association (NYHA)
  4. has ≥ 1 of the following: 1） Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) recorded by echocardiography at the time of enrollment；2）Hospitalization due to heart failure within 12 months before enrollment
  5. Retention of ejection fraction: left ventricular ejection fraction (LVEF)≥50% (Echocardiography)
  6. Increase of NTpro-BNP (patients without atrial fibrillation>220pg/mL, patients with atrial fibrillation>660pg/mL
  7. If diuretics are being administered orally, the dose must be stable for ≥ 2 weeks before inclusion in the study
  8. At the time of randomization, it was clinically stable without signs of decompensation of cardiac failure (judged by the investigator)

Exclusion Criteria:

  1. Patients with decompensated heart failure
  2. Glomerular filtration rate (eGFR)<30mL/min/1.73m 2
  3. Atrial fibrillation or atrial flutter with obvious liver disease or ALT, AST 3 times higher than the upper limit of normal
  4. Symptomatic hypotension or systolic blood pressure (SBP)<100mmHg at the time of inclusion or baseline
  5. Resting heart rate recorded by echocardiography at the time of screening>110bpm
  6. Currently participating in another research equipment or drug test, or less than 30 days after the completion of another research equipment or drug test or receiving other research treatment. Patients participating in purely observational trials will not be excluded
  7. At present, people who are taking traditional Chinese medicine or Chinese patent medicine with similar effect to Qishen Granules
  8. Be allergic to any component of Qishen granules (astragalus membranaceus, salvia miltiorrhiza, and black aconite)
  9. Patients who refuse to sign the informed consent form or estimate poor compliance and women who are pregnant, nursing or planning to become pregnant during the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Qishen Granules
On the basis of standardized drug treatment for HFpEF, participants who met the inclusion criteria were randomly given Qishen Granule intervention on the day of inclusion, taking it twice a day for 90 days.
Drug: Qishen Granules
One package per time, twice a day, 90 days of treatment
Placebo Comparator: Placebo
On the basis of standardized drug treatment for HFpEF, participants who met the inclusion criteria were randomly given placebo granules on the day of inclusion, which were taken twice a day for 90 days (the placebo was basically the same as Qishen granules in terms of appearance, shape, color, taste, etc.)
Drug: Placebo
One package per time, twice a day, 90 days of treatment (the placebo was basically the same as Qishen granules in terms of appearance, shape, color, taste, etc.)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in peak oxygen uptake within the average minute (PeakVO2) compared to baseline on day 90
Time Frame: At enrollment versus at day 90
Measure the efficiency of peak oxygen intake by combining oxygen volume and time to report PeakVO2 in ml/min
At enrollment versus at day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Mitral valve diastolic blood flow velocity (E) and Mitral annulus lateral and septal motion velocity (e') compared to baseline on day 90
Time Frame: At enrollment versus at day 90
Measure the blood flow velocity or motion velocity of specific areas in cm/s
At enrollment versus at day 90
Changes in E/e' ratio compared to baseline on day 90
Time Frame: At enrollment versus at day 90
E/e' ratio
At enrollment versus at day 90
Changes in Left Atrial Volume index (LAVI) compared to baseline on day 90
Time Frame: At enrollment versus at day 90
Left atrial volume (estimated from echocardiography measurement data) and body surface area (estimated based on height and weight) will be combined to report LAVI in ml/m^2
At enrollment versus at day 90
Changes in Left ventricular mass index (LVMI) compared to baseline on day 90
Time Frame: At enrollment versus at day 90
Left ventricle mass (estimated from echocardiography measurement data) and body surface area (estimated based on height and weight) will be combined to report LVMI in g/m^2
At enrollment versus at day 90
Changes in Score of Kansas City Cardiomyopathy Questionnaire (KCCQ) compared to baseline on day 90
Time Frame: At enrollment versus at day 90
Calculate the scores of the KCCQ questionnaire
At enrollment versus at day 90
Changes in blood N terminal pro B type natriuretic peptide(NT-proBNP) compared to baseline on day 90
Time Frame: At enrollment versus at day 90
Level of blood NT-proBNP in mmol/L
At enrollment versus at day 90
Changes in blood Growth STimulation expressed gene 2(ST2) compared to baseline on day 90
Time Frame: At enrollment versus at day 90
Level of blood ST2 in mmol/L
At enrollment versus at day 90
Changes in blood urea compared to baseline on day 90
Time Frame: At enrollment versus at day 90
Level of blood urea in mmol/L
At enrollment versus at day 90
Changes in blood creatinine compared to baseline on day 90
Time Frame: At enrollment versus at day 90
Level of blood creatinine in mmol/L
At enrollment versus at day 90

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Aspartate aminotransferase(AST) compared to baseline on day 90
Time Frame: At enrollment versus at day 90
Level of blood AST in mmol/L
At enrollment versus at day 90
Changes in Alanine aminotransferase(ALT) compared to baseline on day 90
Time Frame: At enrollment versus at day 90
Level of blood ALT in mmol/L
At enrollment versus at day 90
Number of participants with treatment-related adverse events
Time Frame: At enrollment versus at day 90
Assess the incidence of treatment-related adverse events
At enrollment versus at day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Provincial Hospital of Traditional Chinese Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lei Wang, doctorate, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BF-2022-121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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