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

Sponsor

Chongqing Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04269057

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure

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 Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
HFpEF heart failure patients with preserved ejection fraction who using ARNI
HFrEF heart failure patients with reduced ejection fraction who using ARNI

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Chongqing Medical University	Chongqing		China

Sponsors and Collaborators

Chongqing Medical University

Investigators

Study Director: Dongying Zhang, doctor, First Affiliated Hospital of Chongqing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dongying Zhang, Associate Professor, Chongqing Medical University

ClinicalTrials.gov Identifier:

NCT04269057

Other Study ID Numbers:

2019-10

First Posted:

Feb 13, 2020

Last Update Posted:

Feb 17, 2020

Last Verified:

Feb 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Dongying Zhang, Associate Professor, Chongqing Medical University

NLRP3 protein

human

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Feb 17, 2020