Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 10-CC-0153 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Adult men and women without a clinical diagnosis of heart failure | ||
| Patients | Adult men and women with a clinical diagnosis of heart failure |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Post contrast myocardial T1 measured by CMR. | 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 | Study end |
Not provided
Not provided
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.
Preserved left ventricular ejection fraction (EF >50%)
Diastolic dysfunction defined one or more of the following
For the systolic dysfunction arm:
Left ventricular ejection fraction <40%
Normal Control:
G. Men and women without a clinical diagnosis of heart failure.
H. NIH employees may be involved and NIH requirements will be followed as laid out in NIH Policy Manual 2300-630-3 - Leave Policy For NIH Employees Participating In NIH Medical Research Studies.
EXCLUSION CRITERIA:
Individuals will be excluded from the study if they are discovered to have coexistent conditions that may contribute to structural or functional cardiac abnormalities, which may confound interpretation of results, are ineligible for MRI or if they are at increased risk for Nephrogenic Systemic Fibrosis (NSF) including:
A. Contra indications for gadiolinium-based contrast agent:
B. Medical conditions associated with increased collagen turnover which may confound interpretation of biomarkers of collagen synthesis. Examples include systemic amyloid disease, cirrhosis, liver, pulmonary, or renal fibrosis, inflammatory states, cancer, recent trauma or surgery;
C. Pregnant or lactating women;
D. Mental, neurologic or social condition preventing understanding of the rationale, procedures, risks and potential benefits associated with the trial;
E. Any other conditions that precludes safety for MRI or MDCT per the researcher s evaluation.
F. Patients otherwise eligible but with any of the following contraindications for iodine-based CT contrast agent will be excluded from contrast CT angiography but may undergo all other study procedures:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth C Jones, M.D. | National Institutes of Health Clinical Center (CC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23333188 | Derived | Nacif MS, Liu Y, Yao J, Liu S, Sibley CT, Summers RM, Bluemke DA. 3D left ventricular extracellular volume fraction by low-radiation dose cardiac CT: assessment of interstitial myocardial fibrosis. J Cardiovasc Comput Tomogr. 2013 Jan-Feb;7(1):51-7. doi: 10.1016/j.jcct.2012.10.010. Epub 2012 Dec 4. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided