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

Last updated: February 12, 2020
Sponsor: Chongqing Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Chest Pain

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT04269057
2019-10
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • LVEF less than 45% at any time;

  • severe infection;

  • ACS;

  • pregnancy;

  • eGFR ＜30 mL/min/1.73 m2, etc.

Study Design

Total Participants: 90
Study Start date:
October 01, 2019
Estimated Completion Date:
October 01, 2020

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing,
    China

    Active - Recruiting

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