- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04269057
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
-
-
-
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
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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