Noninvasive Imaging of Heart Failure: A Pilot Study
|First Received Date ICMJE||July 9, 2010|
|Last Updated Date||January 14, 2014|
|Start Date ICMJE||June 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Post contrast myocardial T1 measured by CMR.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01160471 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||A) Post contrast myocardial attenuation measured by MDCT. B) LV systolic/diastolic function measured by CMR. C) Serum myocardial extracellular matrix remodelling biomarkers. D) Fibrosis detected by histology analysis in endomyocardial biopsy.|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Noninvasive Imaging of Heart Failure: A Pilot Study|
|Official Title ICMJE||Noninvasive Imaging of Heart Failure|
- 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.
- To conduct a noninvasive comparative imaging study of individuals with heart failure.
- 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).
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 Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||196|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
The common inclusion criteria between patients and controls are:
A. Able to understand and sign informed consent.
B. Able to complete a MRI or CT scan.
C. Age greater than or equal to 18 years old.
Heart Failure subject:
D. Men and women with a clinical diagnosis of heart failure.
E. New York Heart Association functional class II or worse.
F. For the normal ejection fraction arm.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01160471|
|Other Study ID Numbers ICMJE||100153, 10-CC-0153|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institutes of Health Clinical Center (CC)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP