Noninvasive Imaging of Heart Failure: A Pilot Study

Completed

• Conditions: MRI; Myocardial Fibrosis; Acquired Heart Disease

• Registration Number: NCT01160471
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief Summary

Background:

- Heart failure is a common cardiovascular disorder whose incidence increases with age, affecting up to 10% of people older than 65 years of age. As the population ages, the prevalence and cost of heart failure will continue to rise. Researchers are interested in using noninvasive imaging methods to better understand the symptoms and effects of heart failure.

Objectives:

- To conduct a noninvasive comparative imaging study of individuals with heart failure.

Eligibility:

- Individuals at least 18 years of age who have been diagnosed with heart failure (with at least mild symptoms and slight limitations on physical activity).

Design:

* This study will last approximately 2 years and will require four visits to the National Institutes of Health Clinical Center, with one screening visit and three study visits.

* Participants will be screened with a full medical history and physical examination, as well as blood and urine samples.

* Participants will have the following tests during each study visit:

* Physical examination

* Blood and urine samples

* Cardiac magnetic resonance imaging

* Cardiac computerized tomography to study the blood vessels in and leading to the heart

* Echocardiogram to evaluate heart function

* Electrocardiogram to measure heart electrical activity

* The three study visits will take place 1 year apart. Participants will also receive follow-up phone calls 6 months after the first and second visits.

* No treatment will be provided as part of this protocol.

Detailed Description

More than 9% of American men and close to 5% of women ages 60 to 79 years report a diagnosis of heart failure, where above the age of 80 years these figures increase to 13.8% and 12.2%, respectively. Projection into the middle part of this century suggests that, as the population ages, the prevalence and cost of heart failure will continue to rise. The primary aim of this proposal is to investigate noninvasive imaging methods for quantifying diffuse myocardial fibrosis with cardiac magnetic resonance imaging (CMR) in heart failure patients. The secondary aims are to investigate the association between diffuse fibrosis detected by CMR with left ventricular function, and examine the utility of multi-detector CT (MDCT) in detecting diffusion myocardial fibrosis.

Study Timeline

• Study Start: 2010-07-01
• Study First Submitted: 2010-07-09
• Study First Submitted QC: 2010-07-09
• Study First Posted: 2010-07-12
• Status Verified: 2019-10-30
• Study Completion: 2019-10-30
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post contrast myocardial T1 measured by CMR.	Study end	The primary aim of this protocol is to investigate noninvasive imaging methods for quantifying diffuse myocardial fibrosis with cardiac magnetic resonance imaging(CMR) in heart failure patient

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States