Change of NLRP3 Inflammasome Expression Level, Symptoms, and Functional Status in HFpEF Patients Treated With ARNI

• Conditions: Heart Failure

• Registration Number: NCT04269057
• Lead Sponsor: Chongqing Medical University

Brief Summary

Underlying inflammation has been increasingly recognized in heart failure with a preserved ejection fraction(HFpEF). But there is no study reported the relationship between NLRP3 inflammasome and HFpEF. In this study, investigators propose a scientific hypothesis that the expression of NLRP3 inflammasome is elevated in patients with HFpEF, and the level of TNFα, IL-1β and NLRP3 inflammasome is lower in patients treated with sacubitril/valsartan.

Detailed Description

The study will integrate data from two trials involving a total of 90 participants with heart failure. Depending on the using of ARNI, participants in HFpEF group will be divided into two groups. The diagnostic criteria for HFpEF is: (1) left ventricular ejection fraction ≥50%； (2）with the symptoms and/or signs of heart failure; (3) BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL; (4) at least one additional criterion: a.relevant structural heart disease(LVH and/or LAE); b.diastolic dysfunction. The primary outcome are the change from baseline in TNFα, IL-1β, NLRP3 inflammasome, and so on assessed at 12 weeks. The key secondary outcomes include changes in echocardiographic measures, quality of life, etc. And then compare the rate of above indicators of two trials.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2020-01-13
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-12
• Last Update Submitted: 2020-02-12
• Study First Posted: 2020-02-13
• Last Update Posted: 2020-02-17
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• left ventricular ejection fraction ≥50%；
• with the symptoms and/or signs of heart failure；
• BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL；
• at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction.

Exclusion Criteria

• LVEF less than 45% at any time;
• severe infection;
• ACS;
• pregnancy;
• eGFR <30 mL/min/1.73 m2, etc.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change from baseline in TNFα, IL-1β, NLRP3 inflammasome, and so on assessed at 12 weeks	12 weeks	Measuring the level of TNFα, IL-1β, NLRP3 inflammasome, and so on from blood samples at 12 weeks, seperately by PCR and ELISA

Secondary Outcome Measures

Name	Time	Method
The change from baseline in echocardiographic measures and so on	12 months	Observed the change of ejection fraction, left atrial volume index and so on measured by echocardiogram.
The change from baseline in quality of life	12 months	Measured by Kansas City Cardiomyopathy Questionnaire. The score ranges from 0 to 100. The higher score means the better health-related quality of life.

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China