MRINCT01160471
Noninvasive Imaging of Heart Failure: A Pilot Study
An observational study of MRI and Acquired Heart Disease, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- MRI, Acquired Heart Disease, Myocardial Fibrosis
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2010to 30 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The common inclusion criteria between patients and controls are:
- Able to understand and sign informed consent.
- Able to complete a MRI or CT scan.
- Age greater than or equal to 18 years old.
- Heart Failure subject:
- Men and women with a clinical diagnosis of heart failure.
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- New York Heart Association functional class II or worse.
- For the normal ejection fraction arm.
- Preserved left ventricular ejection fraction (EF >50%)
- Diastolic dysfunction defined one or more of the following
- LVEDP > 16 mm Hg
- PCW > 12 mm Hg
- E/E ratio >15
- E/E ratio >8 AND NT-proBNP >220 pg/mL
- For the systolic dysfunction arm:
- Left ventricular ejection fraction <40%
- Normal Control:
- Men and women without a clinical diagnosis of heart failure.
- 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.
Who cannot join
- 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:
- 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
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- Hemoglobinopathies, sickle cell anemia and thalassemias major
- History of multiple myeloma
- History of significant allergic reaction to gadolinium-based contrast agents
- 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;
- Pregnant or lactating women;
- Mental, neurologic or social condition preventing understanding of the rationale, procedures, risks and potential benefits associated with the trial;
- Any other conditions that precludes safety for MRI or MDCT per the researcher s evaluation.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Noninvasive Imaging of Heart Failure
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.
Read more
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.
Read the 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.
- Conditions
- MRI, Acquired Heart Disease, Myocardial Fibrosis
- Keywords
- Heart Failure, MRI, Ultrasound, Fibrosis, Biomarker
- Medical subject headings
- Heart Failure, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study start1 Jul 2010
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MRIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elizabeth C Jones, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160471
- Sponsor's protocol ID
- 100153
- Other IDs
- 10-CC-0153
- Status last verified
- 30 Oct 2019
- First submitted
- 9 Jul 2010
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
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.
PubMed 23333188
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Imaging of Heart Failure
- ClinicalTrials.gov ID
- NCT01160471
- Acronym / sponsor ID
- 100153
- Conditions
- MRI, Acquired Heart Disease, Myocardial Fibrosis
- Keywords
- Heart Failure, MRI, Ultrasound, Fibrosis, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 1 Jul 2010
- Study completion
- 30 Oct 2019
- First posted
- 12 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Able to understand and sign informed consent.
- Able to complete a MRI or CT scan.
- Age greater than or equal to 18 years old.
- Men and women with a clinical diagnosis of heart failure.
- New York Heart Association functional class II or worse.
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post contrast myocardial T1 measured by CMR.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Derived from this study: PubMed 23333188Nacif 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth C Jones, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MRI and Acquired Heart Disease, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post contrast myocardial T1 measured by CMR. (time frame: Study end). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01160471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.