Clinical trial NCT06629246: Pogejiuxin Decoction Combination of Conventional Western Medicine for the Treatment of Heart Failure with Preserved Ejection Fraction
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Diastolic (HFpEF)
Keywords: Pogejiuxin Decoction
heart failure with preserved ejection fraction
Lead sponsor: Chongqing Traditional Chinese Medicine Hospital
Sponsor class: OTHER
Collaborators: name: Chongqing Science and Technology Commission
name: Chongqing Health and Family Planning Commission
First posted: 2024-10-08
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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\&amp;#39;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.

Eligibility criteria: 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 \&gt; 3 times the upper limit or serum creatinine levels \&gt; 265 umol/L or serum potassium \&gt; 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.

Primary outcomes:
measure: NT-proBNP
timeFrame: From enrollment to the end of treatment at 7 days
measure: Echocardiography(LVEF, LVEDD and LVESD)
timeFrame: From enrollment to the end of treatment at 7 days
measure: hs-CRP
timeFrame: From enrollment to the end of treatment at 7 days
measure: Inflammatory Factors(TNF-α, IL-6, and IL-8)
timeFrame: From enrollment to the end of treatment at 7 days
measure: Minnesota Living with Heart Failure Questionnaire (MLHFQ)
timeFrame: From enrollment to the end of treatment at 7 days
Secondary outcomes:
measure: Traditional Chinese Medicine (TCM) Symptom Score
timeFrame: From enrollment to the end of treatment at 7 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Traditional Chinese Medicine Hospital
state: Chongqing
Study officials:
References:
citation: Liu L, Mo Y, Wu B, Yu Z, Sun B. Effect of Traditional Chinese Medicine Poge Heart-Saving Decoction on Cardiac Function in Heart Failure Rat Model. Evid Based Complement Alternat Med. 2020 Dec 3;2020:8762509. doi: 10.1155/2020/8762509. eCollection 2020.
citation: Li X, Zhang J, Huang J, Ma A, Yang J, Li W, Wu Z, Yao C, Zhang Y, Yao W, Zhang B, Gao R; Efficacy and Safety of Qili Qiangxin Capsules for Chronic Heart Failure Study Group. A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure. J Am Coll Cardiol. 2013 Sep 17;62(12):1065-1072. doi: 10.1016/j.jacc.2013.05.035. Epub 2013 Jun 7.
citation: Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Dungen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1.