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
SexALL
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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).
✕. 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.
✕
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 undergoing coronary intervention, cardiac pacemaker implantation, placement of cardiac assist devices, or other treatments during the trial period.