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

February 12, 2020 updated by: Dongying Zhang, Chongqing Medical University

Change of NLRP3 Inflammasome Expression Level, Symptoms, and Functional Status in Patients With Heart Failure With Preserved Ejection Fraction Treated With ARNI

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

heart failure patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HFpEF
heart failure patients with preserved ejection fraction who using ARNI
HFrEF
heart failure patients with reduced ejection fraction who using ARNI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2019

Primary Completion (ANTICIPATED)

October 1, 2020

Study Completion (ANTICIPATED)

October 1, 2020

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (ACTUAL)

February 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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