Pogejiuxin Decoction Combination of Conventional Western Medicine for the Treatment of Heart Fail… (NCT06629246) | Clinical Trial Compass
CompletedNot Applicable
Pogejiuxin Decoction Combination of Conventional Western Medicine for the Treatment of Heart Failure With Preserved Ejection Fraction
China100 participantsStarted 2021-09-01
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. Inpatients who meet the diagnostic criteria for heart failure in TCM Internal Medicine(2012 edition);
. Patients who meet the diagnostic criteria for HfpEF by heart color ultrasound;
. Patients who sign informed consent and take the test voluntarily.
Exclusion criteria
. Patients who do not meet the inclusion criteria.
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
NT-proBNP
Timeframe: From enrollment to the end of treatment at 7 days
2
Echocardiography(LVEF, LVEDD and LVESD)
Timeframe: From enrollment to the end of treatment at 7 days
3
hs-CRP
Timeframe: From enrollment to the end of treatment at 7 days
4
Inflammatory Factors(TNF-α, IL-6, and IL-8)
Timeframe: From enrollment to the end of treatment at 7 days
5
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Timeframe: From enrollment to the end of treatment at 7 days
Trial details
NCT IDNCT06629246
SponsorChongqing Traditional Chinese Medicine Hospital
. 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.
. Patients with severe pneumonia, serious infections, or acute exacerbation of chronic obstructive pulmonary disease.
. Pregnant or nursing women.
. Patients with psychiatric abnormalities or unwilling to cooperate.
. Patients allergic to the components of Pogejiuxin Decoction.
. Patients undergoing coronary intervention, cardiac pacemaker implantation, placement of cardiac assist devices, or other treatments during the trial period.