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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04269057
• Other study ID #: 2019-10
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: February 2020
• Source: Chongqing Medical University
• Contact: Dongying Zhang, doctor
• Phone: +8613608398395
• Email: zdy.chris[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in TNFa, IL-1ß, NLRP3 inflammasome, and so on assessed at 12 weeks	Measuring the level of TNFa, IL-1ß, NLRP3 inflammasome, and so on from blood samples at 12 weeks, seperately by PCR and ELISA	12 weeks
Secondary	The change from baseline in echocardiographic measures and so on	Observed the change of ejection fraction, left atrial volume index and so on measured by echocardiogram.	12 months
Secondary	The change from baseline in quality of life	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