Noninvasive Imaging of Heart Failure: A Pilot Study

Completed

Conditions studied: MRI, Acquired Heart Disease, Myocardial Fibrosis

In brief

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.

Key facts

Study ID

NCT01160471

Run by

National Institutes of Health Clinical Center (CC)

People needed

62

Starts

2010-07-01

Expected to finish

2019-10-30

Last updated by the study team

2019-12-12

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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:
• eGFR < 30ml/min/1.73m(2)
• Acute renal failure, renal transplantation, current dialysis treatment or hepatorenal syndrome
• History of liver transplantation or severe liver disease
• Severe Asthma
• Hemoglobinopathies, sickle cell anemia and thalassemias major
• History of multiple myeloma
• History of significant allergic reaction to gadolinium-based contrast agents
• 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:
• Renal dysfunction (defined as eGFR <45 mL/min/m(2))
• Current clinical diagnosis of renal failure
• Prior hypersensitivity to iodine containing substances (shellfish, iodine, and or previous contrast reactions to contrast agents.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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