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Congenital Heart DiseaseNCT01639937

Myocardial Perfusion and Scarring in Congenital Heart Disease

An observational study of Congenital Heart Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Background: People with congenital heart disease may develop heart failure earlier that those who do not have the disease. One theory to explain this is that the heart s own blood supply may be different in people with congenital heart disease. Problems with this blood supply can severely damage the heart. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Congenital Heart Disease
How many people
18 participants
Where
3 sitesUnited States
Study dates
24 Oct 2012to 12 Dec 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants will be enrolled at the NIH Clinical Center, Suburban Hospital, or Children s National Medical Center (CNMC). We will recruit subjects of the Washington Adult Congenital Heart program at CNMC to participate in this study.@@@@@@

Who may be able to join

  • Subjects 18 years of age or older
  • All defects that have a right ventricle that supports the systemic circulation
  • All defects with a functional single ventricle
  • Written informed consent

Who cannot join

  • Subjects with a contraindication to MRI scanning will be excluded. These contraindications include subjects with the following devices:
  • Central nervous system aneurysm clips
  • Implanted neural stimulator
  • Implanted cardiac pacemaker or defibrillator
  • Cochlear implant
  • Ocular foreign body (e.g. metal shavings)
Show all 22Show fewer
  • Implanted Insulin pump
  • Metal shrapnel or bullet
  • Severe heart damage that makes it difficult to breathe while lying flat
  • Pregnant women (Women of childbearing potential who are uncertain as to whether they are pregnant will be required to have a screening urine or blood pregnancy test)
  • Subjects with active symptoms of myocardial ischemia occurring despite maximally tolerated doses of oral antianginal therapy and intravenous nitroglycerin
  • Furthermore, the following subject groups will be excluded from studies involving the administration of MRI contrast agents:
  • lactating women unless they are willing to discard breast milk for 24 hours after receiving gadolinium
  • renal disease (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73 m2 body surface area)
  • The eGFR will be used to estimate renal function if reported by the laboratory. Otherwise, estimated glomerular filtration rate (eGFR) can be based on the Modification of Diet in Renal Disease (MDRD) study equation (see below) in subjects with stable renal function. This formula is not applicable to subjects with acute renal insufficiency:
  • eGFR (ml/min/1.73 m2) = 175 x (serum creatinine)-1.154 x (age)-0.203 x 0.742 (if the subject is female) x 1.212 (if the subject is black)
  • Additional Exclusion Criteria for Vasodilator Stress MRI:
  • Myocardial infarction within 24 hours
  • Uncontrolled heart failure
  • Uncontrolled asthma or emphysema
  • Ventricular arrhythmia (sustained ventricular arrhythmia at the time of MR scan)
  • Second degree heart block or higher

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

  • Childrens National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: Quantitative Myocardial Perfusion, Myocardial Scarring and Their Contribution to Late Clinical Decompensation in Adults With Congenital Heart Disease

Background:

  • People with congenital heart disease may develop heart failure earlier that those who do not have the disease. One theory to explain this is that the heart s own blood supply may be different in people with congenital heart disease. Problems with this blood supply can severely damage the heart. This damage can be studied with a heart imaging test called a cardiac magnetic resonance imaging (MRI) scan. Researchers want to use this type of scan to look at the blood supply to the heart in people with congenital heart disease.
Read more

Objectives:

  • To learn more about the blood supply to the heart in people with congenital heart disease.

Eligibility:

  • Individuals at least 18 years of age who have heart defects caused by congenital heart disease.

Design:

  • Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
  • Participants will have a cardiac MRI scan to look at the blood flow to the heart.
  • Participants will also have a heart stress test to measure heart function during exercise.
  • Other imaging studies of the heart may be performed to collect more information on heart function.
Read the detailed description

This is a study of the perfusion of the myocardium in adults with specific forms of repaired congenital heart disease using established cardiac MRI techniques and correlating perfusion with clinical outcomes. Our objectives are to examine myocardial perfusion both during stress and at rest in adults with repaired or palliated congenital heart disease as well as quantify ventricular function, regional myocardial strain and evidence of myocardial fibrosis with quantitative measures of myocardial perfusion. The specific aim of this study is to understand whether clinical subendocardial perfusion defects contribute to the late decompensation of adult subjects that have single ventricle physiology and adult subjects that have a systemic right ventricle.

Keywords
Cardiac MRI, Congestive Heart Failure, Cardiac Fibrosis, Late Gadolinium Enhancement
Medical subject headings
Heart Defects, Congenital, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01639937
Study groupRoleWhat they receive
1Subjects with palliated congenital heart disease including, but not limited to, d TGA, ccTGA, single ventricles, hypoplastic left heart syndrome and tricuspid atresia will be recruited

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hypothesize that myocardial ischemia, as detectable by quantitative stress perfusion MRI, will predict systolic and diastolic dysfunction in subjects with single ventricle physiology and systemic right ventricles.

    The specific aim of this study is to understand whether clinical subendocardial perfusion defects contribute to the late decompensation of adult subjects that have single ventricle physiology and adult subjects that have a systemic right ventricle.

    Measured: 5 years

Secondary outcomes (2)

  1. A portion of ventricular systolic or diastolic dysfunction will be predictable based on myocardial fibrosis or scarring related to the underlying pathophysiology of single ventricle physiology &amp; systemic right ventricles or post-surgical...

    A portion of ventricular systolic or diastolic dysfunction will be predictable based on myocardial fibrosis or scarring related to the underlying pathophysiology of single ventricle physiology \&amp; systemic right ventricles or post-surgical consequences.

    Measured: 5 years

  2. myocardial scarring/fibrosis will correlate with symptoms, NYHA functional class and BNP.

    myocardial scarring/fibrosis will correlate with symptoms, NYHA functional class and BNP.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2012 (estimated)
  2. Study start24 Oct 2012
  3. Primary completion1 Apr 2017
  4. Study completion12 Dec 2019

Why it stopped: PI is leaving NHLBI, sample size is too small.

Resources

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
Cohort
Time perspective
Prospective
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01639937
Sponsor's protocol ID
120158
Other IDs
12-H-0158
Status last verified
Nov 2021
First submitted
11 Jul 2012
Last updated
2 Dec 2021
Results posted
No

Publications

  • Verheugt CL, Uiterwaal CS, van der Velde ET, Meijboom FJ, Pieper PG, van Dijk AP, Vliegen HW, Grobbee DE, Mulder BJ. Mortality in adult congenital heart disease. Eur Heart J. 2010 May;31(10):1220-9. doi: 10.1093/eurheartj/ehq032. Epub 2010 Mar 5.

    PubMed 20207625

  • Rutledge JM, Nihill MR, Fraser CD, Smith OE, McMahon CJ, Bezold LI. Outcome of 121 patients with congenitally corrected transposition of the great arteries. Pediatr Cardiol. 2002 Mar-Apr;23(2):137-45. doi: 10.1007/s00246-001-0037-8. Epub 2002 Feb 19.

    PubMed 11889523

  • Meijboom F, Szatmari A, Deckers JW, Utens EM, Roelandt JR, Bos E, Hess J. Long-term follow-up (10 to 17 years) after Mustard repair for transposition of the great arteries. J Thorac Cardiovasc Surg. 1996 Jun;111(6):1158-68. doi: 10.1016/s0022-5223(96)70217-9.

    PubMed 8642816

Questions about this trial

What is this clinical trial studying?

An observational study of Congenital Heart Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 3 sites 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 4 inclusion and 22 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: stopped early, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 was stopped early (reason given: PI is leaving NHLBI, sample size is too small.). Results are not available in the source record.

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?

Hypothesize that myocardial ischemia, as detectable by quantitative stress perfusion MRI, will predict systolic and diastolic dysfunction in subjects with single ventricle physiology and systemic right ventricles. (time frame: 5 years). 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 NCT01639937, which also lists 3 linked publications.

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 2 Dec 2021.

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