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Protocol Details

Noninvasive Imaging of Heart Failure

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-CC-0153

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Heart Failure;
Computed Tomography;
Ultrasound;
Fibrosis;
Biomarker

Recruitment Keyword(s)

None

Condition(s)

Magnetic Resonance Imaging;
Acquired Heart Disease;
Myocardial Fibrosis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

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.

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Eligibility

INCLUSION CRITERIA:

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.

1. Preserved left ventricular ejection fraction (EF > 50%)

2. Diastolic dysfunction defined one or more of the following

a. LVEDP > 16 mm Hg

b. PCW > 12 mm Hg

c. E/E ratio > 15

d. E/E ratio > 8 AND NT-proBNP > 220 pg/mL

For the systolic dysfunction arm:

3. 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:

a. eGFR < 30ml/min/1.73m(2)

b. Acute renal failure, renal transplantation, current dialysis treatment or hepatorenal syndrome

c. History of liver transplantation or severe liver disease

d. Severe Asthma

e. Hemoglobinopathies, sickle cell anemia and thalassemias major

f. History of multiple myeloma

g. History of significant allergic reaction to gadolinium-based contrast agents

B. Coronary artery disease with unstable symptoms or acute coronary syndrome within the last six months.

C. 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;

D. Pregnant or lactating women;

E. Mental, neurologic or social condition preventing understanding of the rationale, procedures, risks and potential benefits associated with the trial;

F. Any other conditions that precludes safety for MRI or MDCT per the researcher s evaluation.

G. 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:

a. Renal dysfunction (defined as eGFR < 45 mL/min/m(2))

b. Current clinical diagnosis of renal failure

c. Prior hypersensitivity to iodine containing substances (shellfish, iodine, and or previous contrast reactions to contrast agents.


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Citations:

Daly MG, Frampton CM, Troughton RW. Improving risk stratification for heart failure. A role for serial testing of B-type natriuretic peptides? J Am Coll Cardiol. 2010 Feb 2;55(5):451-3.

Rademakers FE, Bogaert J. Cardiac dysfunction in heart failure with normal ejection fraction: MRI measurements. Prog Cardiovasc Dis. 2006 Nov-Dec;49(3):215-27.

Mann DL. Mechanisms and models in heart failure: A combinatorial approach. Circulation. 1999 Aug 31;100(9):999-1008.

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Contacts:

Principal Investigator

Referral Contact

For more information:

David A. Bluemke, M.D.
National Institutes of Health Clinical Center (CC)
BG 10 RM 1C355
10 CENTER DR
BETHESDA MD 20814
(301) 402-1854
bluemked@mail.nih.gov

Marissa B. Mallek
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1C351
10 Center Drive
Bethesda, Maryland 20892
(301) 496-7700
marissa.mallek@nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01160471

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