Pogejiuxin Decoction Combination of Conventional Western Medicine for the Treatment of Heart Failure with Preserved Ejection Fraction

October 3, 2024 updated by: Chongqing Traditional Chinese Medicine Hospital

A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Pogejiuxin Decoction Combination of Conventional Treatment for Heart Failure with Preserved Ejection Fraction(HFpEF)

The objective of this study is to investigate the potential of Pogejiuxin Decoction to enhance the efficacy and mitigate the adverse effects associated with conventional treatment in patients with heart failure and preserved ejection fraction(HFpEF), thereby establishing a foundation for its clinical application in managing HFpEF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study recruits patients with heart failure and preserved ejection fraction(HFpEF), randomly assigning them to either the intervention group or the control group. The control group will receive the standard heart failure treatment protocol, while the intervention group will take Pogejiuxin Decoction orally in addition to the control group's treatment. The study will compare the degree of symptom improvement, relevant auxiliary examination indicators, traditional Chinese medicine syndrome scores, and adverse reaction differences between the two groups, providing a clinical basis for the further enhancement of HFpEF treatment with the combination of Pogejiuxin Decoction and conventional therapy.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • 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 Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Chongqing Traditional Chinese Medicine Hospital

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Inpatients with heart failure who meet the diagnostic criteria of China Guidelines for the Diagnosis and Treatment of Heart Failure 2018 and have grade II-IV heart function;
  2. Inpatients who meet the diagnostic criteria for heart failure in TCM Internal Medicine(2012 edition);
  3. Patients who meet the diagnostic criteria for HfpEF by heart color ultrasound;
  4. Patients who sign informed consent and take the test voluntarily.

Exclusion Criteria:

  1. Patients who do not meet the inclusion criteria.
  2. Patients with severe hepatic or renal impairment (ALT/AST > 3 times the upper limit or serum creatinine levels > 265 umol/L or serum potassium > 5.5 mmol/L).
  3. Patients with severe cerebrovascular, hematological, neurological diseases, or malignant tumors that require special treatment during the study period and may affect the judgment of heart failure treatment efficacy.
  4. Patients with severe pneumonia, serious infections, or acute exacerbation of chronic obstructive pulmonary disease.
  5. Pregnant or nursing women.
  6. Patients with psychiatric abnormalities or unwilling to cooperate.
  7. Patients allergic to the components of Pogejiuxin Decoction.
  8. Patients undergoing coronary intervention, cardiac pacemaker implantation, placement of cardiac assist devices, or other treatments during the trial period.

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: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
The control group will receive conventional heart failure treatment, which may include pharmacological therapies such as diuretics, ACE inhibitors/ARBs, beta-blockers, or aldosterone receptor antagonists, based on the clinical requirements of the condition, for a treatment period of 7 days.
Drug: Conventional heart failure treatment
Conventional heart failure treatment, which may include pharmacological therapies such as diuretics, ACE inhibitors/ARBs, beta-blockers, or aldosterone receptor antagonists, based on the clinical requirements of the condition.
Active Comparator: intervention group
The intervention group will receive Pogejiuxin Decoction orally, in addition to the treatment protocol given to the control group.The specific medicinal formula is as follows: Processed Aconite 60g (decocted initially for 1 hour), Dried Ginger 60g, Honey-fried Licorice 60g, Cornus officinalis 60g, Ginseng 30g (decocted separately), Raw Dragon Bone 30g (decocted initially for 1 hour), Raw Oyster Shell 30g (decocted initially for 1 hour), Living Magnetite 30g, for a total of 7 prescriptions. Usage: Uniformly decocted with a herbal medicine decoction machine to obtain the medicinal liquid, one prescription per day, taken twice daily in the morning and evening, each time 100ml, for a continuous treatment of 7 days.
Drug: Pogejiuxin decoction combined with conventional heart failure treatment
In addition to receiving standard heart failure treatment, patients are also administered Pogejiuxin Decoction.The formula of Pogejiuxin Decoction is as follows : Processed Aconite 60g (decocted initially for 1 hour), Dried Ginger 60g, Honey-fried Licorice 60g, Cornus officinalis 60g, Ginseng 30g (decocted separately), Raw Dragon Bone 30g (decocted initially for 1 hour), Raw Oyster Shell 30g (decocted initially for 1 hour), Living Magnetite 30g, for a total of 7 prescriptions. Usage: Uniformly decocted with a herbal medicine decoction machine to obtain the medicinal liquid, one prescription per day, taken twice daily in the morning and evening, each time 100ml, for a continuous treatment of 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NT-proBNP
Time Frame: From enrollment to the end of treatment at 7 days

NT-proBNP, secreted by cardiac muscle cells, serves as a biomarker that reflects cardiac function. Under normal conditions, the body contains a small amount of NT-proBNP. However, in cases of heart failure, the levels of NT-proBNP increase, making it one of the indicators for diagnosing heart failure and assessing the effectiveness of heart failure treatment. The specific diagnostic criteria are as follows:

For patients under 50 years of age: over 450 ng/L; For patients aged from 50 to 75: over 900 ng/L; For patients over 75 years of age: over 1800 ng/L; For patients with impaired renal function (glomerular filtration rate over 60 mL/min): over 1200 ng/L.
From enrollment to the end of treatment at 7 days
Echocardiography(LVEF, LVEDD and LVESD)
Time Frame: From enrollment to the end of treatment at 7 days

Echocardiography is used to assess cardiac function. LVEF Left ventricular ejection fraction (LVEF) is the most commonly used indicator to evaluate left ventricular systolic function in clinical practice. LVEF is calculated from the measurements of end-diastolic volume (EDV) and end-systolic volume (ESV), using the following formula:LVEF = (EDV - ESV) / EDV × 100%. An LVEF of less than 52% in males and less than 53% in females suggests abnormal left ventricular systolic function. An LVEF between 40% and 52% indicates mildly reduced left ventricular systolic function, 30% to 40% indicates moderately reduced function, and less than 30% indicates severely reduced function.

LVEDD and LVESD In males, a left ventricular end-diastolic diameter (LVEDD) over 55 mm and in females over 50 mm, and a left ventricular end-systolic diameter (LVESD) over 37 mm in males and over 35 mm in females, suggest left ventricular dilation and impaired left ventricular function.
From enrollment to the end of treatment at 7 days
hs-CRP
Time Frame: From enrollment to the end of treatment at 7 days

High-sensitivity C-reactive protein (hs-CRP) is one of the most potent predictors of cardiovascular risk events, with the following clinical implications:

A level of under 1 mg/L indicates low risk; A level of 1-3 mg/L indicates moderate risk; A level above 3 mg/L indicates high risk.
From enrollment to the end of treatment at 7 days
Inflammatory Factors(TNF-α, IL-6, and IL-8)
Time Frame: From enrollment to the end of treatment at 7 days
Clinical practice has confirmed that levels of inflammatory cytokines such as TNF-α, IL-6, and IL-8 are elevated in patients with heart failure compared to the general population. These inflammatory factors can further exacerbate myocardial damage and participate in the process of ventricular remodeling. Therefore, monitoring TNF-α, IL-6, and IL-8 can be used to assess the condition of patients with heart failure. Elevated levels of TNF-α over 5 ng/L (bioactivity assay), IL-6 over 10 ng/L, and IL-8 over 21.3 μg/L (ELISA method) suggest the presence of inflammation in the body.
From enrollment to the end of treatment at 7 days
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time Frame: From enrollment to the end of treatment at 7 days
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a widely used instrument for assessing health-related quality of life in patients with heart failure (HF). It evaluates quality life of patients across three domains: physical, emotional, and other. The questionnaire consists of 21 items, with responses rated on a scale from zero to five, indicating none (0 points), very little (1 point), a little (2 points), moderate (3 points), quite a bit (4 points), and severe (5 points). The scores of all items are summed up, with higher scores indicating poorer quality of life.
From enrollment to the end of treatment at 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Traditional Chinese Medicine (TCM) Symptom Score
Time Frame: From enrollment to the end of treatment at 7 days
According to the Guiding Principles for Clinical Research of New Drugs in Traditional Chinese Medicine. The Traditional Chinese Medicine (TCM) symptoms are categorized into primary and secondary symptoms and are scored based on their severity. Primary symptoms include palpitations, fatigue, dyspnea, and lower limb edema, each rated on a scale of four levels: none (0 points), mild (2 points), moderate (4 points), and severe (6 points). Secondary symptoms include lethargy, abdominal distension, oliguria, spontaneous sweating, and dull complexion/cyanosis of lips and nails, each rated on a scale of four levels: none (0 points), mild (1 point), moderate (2 points), and severe (3 points). The total score from all items represents the TCM symptom score.The higher the score, the more severe the symptoms.
From enrollment to the end of treatment at 7 days

Collaborators and Investigators

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

Sponsor

Chongqing Traditional Chinese Medicine Hospital

Collaborators

Chongqing Science and Technology Commission
Chongqing Health and Family Planning Commission

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2021

Primary Completion (Actual)

August 20, 2023

Study Completion (Actual)

September 17, 2023

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-ky-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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