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

  • STATUS
    Recruiting
  • participants needed
    90
  • sponsor
    Chongqing Medical University
Updated on 19 February 2024
heart disease
ejection fraction
valsartan
ntprobnp
diastolic dysfunction
n-terminal pro-bnp
sacubitril

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 TNF, IL-1 and NLRP3 inflammasome is lower in patients treated with sacubitril/valsartan.

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% (2with the symptoms and/or signs of heart failure; (3) BNP35 pg/mL and/or NTproBNP125 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 TNF, IL-1, 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.

Details
Condition Heart failure, Heart failure, Heart disease, Heart disease
Age 100years or below
Clinical Study IdentifierNCT04269057
SponsorChongqing Medical University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

left ventricular ejection fraction 50%
with the symptoms and/or signs of heart failure
BNP35 pg/mL and/or NTproBNP125 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
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