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

Overview

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.

Full Title of Study: “Change of NLRP3 Inflammasome Expression Level, Symptoms, and Functional Status in Patients With Heart Failure With Preserved Ejection Fraction Treated With ARNI”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 12, 2021

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.

Arms, Groups and Cohorts

  • HFpEF
    • heart failure patients with preserved ejection fraction who using ARNI
  • HFrEF
    • heart failure patients with reduced ejection fraction who using ARNI

Clinical Trial Outcome Measures

Primary Measures

  • The change from baseline in TNFα, IL-1β, NLRP3 inflammasome, and so on assessed at 12 weeks
    • Time Frame: 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 Measures

  • The change from baseline in echocardiographic measures and so on
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chongqing Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dongying Zhang, Associate Professor – Chongqing Medical University
  • Overall Official(s)
    • Dongying Zhang, doctor, Study Director, First Affiliated Hospital of Chongqing Medical University
  • Overall Contact(s)
    • Dongying Zhang, doctor, +8613608398395, zdy.chris@qq.com

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