Heart FailureNCT03822442
MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients
An observational study of Heart Failure and Cardiac Imaging Techniques, run by Children's National Research Institute at 1 site in United States.
Trial summary
Overall Research Strategy of this protocol is to refine and validate noninvasive CMR imaging sequences with invasive hemodynamic and pathology results to create a comprehensive, noninvasive, radiation-reduced regimen for pediatric cardiomyopathy and cardiac transplant assessment. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Heart Failure, Cardiac Imaging Techniques, Congenital Heart Defects
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2019to 31 Dec 2025
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals referred to Children's National Medical Center with heart transplant or cardiomyopathy (i.e. "pre-transplant") to undergo clinically-indicated cardiac catheterization will be considered candidates for inclusion.
Who may be able to join
- Children and adults of any age with heart transplant, suspected or confirmed cardiomyopathy
- Undergoing clinically-indicated ("medically necessary") cardiovascular catheterization
Who cannot join
- Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support.
- Women who are pregnant
- Women who are nursing and who do not plan to discard breast milk for 24 hours
- Central nervous system aneurysm clips
- Implanted neural stimulator
- Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
Show all 15Show fewer
- Cochlear implant
- Ocular foreign body (e.g. metal shavings)
- Implanted Insulin pump
- Metal shrapnel or bullet.
- Renal disease with 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.
- The Schwartz equation 33 for estimation of GFR in children as recommended by the NKDEP is as follows:
- GFR (mL/min/1.73 m2) = (k × height) / serum creatinine concentration
- where k = constant defined as follows: k = 0.33 in premature infants k = 0.45 in term infants to 1 year of age k = 0.55 in children to 13 years of age k = 0.70 in adolescent males (not females because of the presumed increase in male muscle mass, the constant remains 0.55 for females) Height in cm Serum creatinine in mg/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Health System
Washington D.C., District of Columbia, 20010
About this study
Official title: Cardiac MRI Increases Accuracy and Decreases Risk of Evaluation of Children With Cardiomyopathy and Cardiac Transplantation
Overall Research Strategy of this protocol is to refine and validate noninvasive CMR imaging sequences with invasive hemodynamic and pathology results to create a comprehensive, noninvasive, radiation-reduced regimen for pediatric cardiomyopathy and cardiac transplant assessment. We were the first to perform MR-guided cardiac catheterization in US children, and have accumulated the largest US experience, having performed over 75 procedures to date. Our unique experience puts us in strong position to leverage this technology to improve care of children with cardiomyopathy and transplant. Using an integrated approach, we will simultaneously (1) validate imaging measures of cardiac edema and fibrosis by correlating T1 and T2 map images with endomyocardial biopsy (EMB) results in Aim 1; (2) overlay T1, T2 map images into our x-ray system to display "hotspots" of T1 and T2 abnormalities to guide EMB in Aim 2; and (3) obtain radiation-free hemodynamic data in a highly vulnerable pediatric population by using CMR to guide catheter manipulation in the ICMR suite in Aim 3.
Age and diagnosis-matched historical controls will be identified from the last 10 years at Children's National as a control population for specific purposes of comparing (1) EMB yield without image overlay and (2) Radiation exposure during X-ray guided right heart catheterization. Identical information will be obtained and stored in the same 45CFR compliant database. Historical controls will be identified from the cardiac catheterization database by searching for age and diagnosis. A waiver of consent will be applicable here, as it would be inconvenient, insensitive and not feasible to consent families who have already undergone treatment.
Read the detailed description
Anesthesia and Vascular Access After final review of protocol eligibility and of MRI safety, vascular access is obtained and sheaths are secured and covered with a sterile drape for transfer to the MRI. The catheterization is performed with continuous recording of electrocardiogram signals, transcutaneous hemoglobin ("pulse") oximetry, and under direct observation of an anesthesia licensed independent provider.
Diagnostic Cardiac MRI Before MRI catheterization begins, a focused cardiac MRI is performed to understand cardiac function and localize the proposed catheter trajectory from the access site into the targeted cardiovascular chambers.
MRI-guided catheterization Next during real-time MRI, a passive catheter is advanced from the access site into the targeted cardiovascular chambers under imaging guidance. Hemodynamic measurements (using fluid-filled transducers connected to the catheters) and blood hemoglobin saturation specimens are obtained from targeted cardiovascular chambers. Additional clinically-indicated and, if time allows, up to 30 minutes of research MRI is then performed before the subject is returned to the X-ray system.
Research MR Imaging Additional research cardiac MRI imaging to determine T1 and T2 values is undertaken next, with 6 short axis slices and one long axis slice positions identified for T1 map and T2 map acquisitions. The ICMR laboratory has a robust experience with acquisition of parametric mapping sequences. T1 and T2 maps will provide a roadmap for the cardiac biopsy that the patient requires in the xray suite.
Image Fusion to Guide Endomyocardial Biopsy At the conclusion of the MR imaging and MR-guided right heart catheterization procedure, the subject is returned to the X-ray suite for cardiac biopsy. Some cardiac biopsies are obtained in the usual fashion, and some biopsy specimens are obtained using image overlay software to display the regions of abnormal T1 and T2 onto the fluoroscopy system.
Conclusion of the procedure Following standard of care EMB, standard of care coronary angiography is obtained when if clinically indicated, all catheters and sheaths are removed and the subject is observed for complications in the cardiac procedure recovery unit or intensive care unit for at least 6 hours.
Diagnostic Echocardiogram Standard clinical data with strain analysis will be collected from the echocardiogram that is performed as a standard of care. Patients undergo a clinically indicated echocardiogram exam following the catheterization procedure in the Cardiac Post Recovery Unit (CPRU).
Blood Tests Serum for creatinine blood test will be collected at the time the clinically indicated IV is placed. Creatinine Is the standard test used at Children's National to assess kidney function. A total of 1cc of blood will be drawn to complete the test.
For subjects who consent to the optional study, an additional 5cc of blood work will be drawn at the time that the intravascular catheter is inserted for the clinically indicated cardiac catheterization procedure. The blood samples will be identified with the study ID number only, and will be stored in a secure freezer owned and maintained by the department of cardiology located at the Sheikh Zayed campus. This blood will be used to identify serum biomarkers, and to validate the potential use for diagnostic purposes.
Follow-up procedures At the conclusion of the procedure, the subject is returned to the X-ray table and all catheters are removed. The subject is observed for complications in an advanced nursing recovery unit or intensive care unit for at least 6 hours. The subject will be assessed for early and late complications at the time of discharge, and again approximately 2-6 weeks ± 7 days post procedure.
MRI Image Analysis In all cardiomyopathy and heart transplant patients, T1 measurements will be performed using offline analysis software according to our laboratory's measurement SOP for parametric maps. In heart transplant patients only, T2 measurements will be performed according to our laboratory's measurement SOP for parametric maps. Following measurements, images will be created for Image Overlay onto the fluoroscopy for patients undergoing clinically-indicated cardiac biopsy following the catheterization.
Biopsy Sample Analysis All biopsy samples will be evaluated clinically for evidence of cellular rejection, and a clinical report will be generated per clinical standard of care. In addition, each of the samples will undergo a separate staining procedure to identify regions of fibrosis. Digital images will be taken of the stained samples. Image processing software will be used to quantify percent fibrosis.
Historical Controls (for radiation exposure comparison, and biopsy yield comparison) Age and diagnosis-matched historical controls will be identified from the last 10 years at Children's National as a control population for specific purposes of comparing (1) EMB yield without image overlay and (2) Radiation exposure during X-ray guided right heart catheterization. Identical information will be obtained and stored in the same 45CFR compliant database. Historical controls will be identified from the cardiac catheterization database by searching for age and diagnosis. A waiver of consent will be applicable here, as it would be inconvenient, insensitive and not feasible to consent families who have already undergone treatment.
Subjects will not be provided additional information as a result of this research study.
Data will be reviewed in aggregate generating generalizable knowledge not applicable to an individual subject
- Keywords
- Cardiomyopathy, cardiomegaly, cardiac transplant
- Medical subject headings
- Heart Failure, Heart Defects, Congenital, Cardiomyopathies, Cardiomegaly
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate MRI imaging results to biopsy results Correlate MRI imaging with endomyocardial biopsy
Correlate MRI imaging sequences that can detect inflammation and fibrosis to quantities of inflammation and fibrosis seen on biopsy specimens taken from the same region.
Measured: At the end of each catheterization procedure through study completion,up to 5 years
Secondary outcomes (2)
Compare yield of biopsy specimen collection using x-ray vs x-ray fused MRI images
To compare the accuracy and yield of biopsy specimens collected for detection of rejection by using standard of care, unguided x-ray imaging for the biopsy to the accuracy and yield results of specimens collected using x-ray fused with MR imaging overlay for guidance towards "hotspots" of fibrosis and inflammation.
Measured: At the end of each catheterization procedure through study completion,up to 5 years
Radiation exposure
To compare radiation exposure in this cohort of subjects (pre and post heart transplant) with recent historical controls undergoing matched invasive cardiology procedures at Children's National Medical Center prior to use of MR-guided cardiac catheterization.
Measured: At the end of each catheterization procedure through study completion,up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start10 Dec 2019
- Primary completion30 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Olivieri, University of Pittsburgh
- Investigators
- Laura Olivieri, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822442
- Sponsor's protocol ID
- 11408
- Status last verified
- Mar 2026
- First submitted
- 28 Jan 2019
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hsu DT, Pearson GD. Heart failure in children: part I: history, etiology, and pathophysiology. Circ Heart Fail. 2009 Jan;2(1):63-70. doi: 10.1161/CIRCHEARTFAILURE.108.820217. No abstract available.
PubMed 19808316Lee TM, Hsu DT, Kantor P, Towbin JA, Ware SM, Colan SD, Chung WK, Jefferies JL, Rossano JW, Castleberry CD, Addonizio LJ, Lal AK, Lamour JM, Miller EM, Thrush PT, Czachor JD, Razoky H, Hill A, Lipshultz SE. Pediatric Cardiomyopathies. Circ Res. 2017 Sep 15;121(7):855-873. doi: 10.1161/CIRCRESAHA.116.309386.
PubMed 28912187Lipshultz SE, Cochran TR, Briston DA, Brown SR, Sambatakos PJ, Miller TL, Carrillo AA, Corcia L, Sanchez JE, Diamond MB, Freundlich M, Harake D, Gayle T, Harmon WG, Rusconi PG, Sandhu SK, Wilkinson JD. Pediatric cardiomyopathies: causes, epidemiology, clinical course, preventive strategies and therapies. Future Cardiol. 2013 Nov;9(6):817-48. doi: 10.2217/fca.13.66.
PubMed 24180540McKenna WJ, Maron BJ, Thiene G. Classification, Epidemiology, and Global Burden of Cardiomyopathies. Circ Res. 2017 Sep 15;121(7):722-730. doi: 10.1161/CIRCRESAHA.117.309711.
PubMed 28912179Badano LP, Miglioranza MH, Edvardsen T, Colafranceschi AS, Muraru D, Bacal F, Nieman K, Zoppellaro G, Marcondes Braga FG, Binder T, Habib G, Lancellotti P; Document reviewers. European Association of Cardiovascular Imaging/Cardiovascular Imaging Department of the Brazilian Society of Cardiology recommendations for the use of cardiac imaging to assess and follow patients after heart transplantation. Eur Heart J Cardiovasc Imaging. 2015 Sep;16(9):919-48. doi: 10.1093/ehjci/jev139. Epub 2015 Jul 2.
PubMed 26139361Dayton JD, Kanter KR, Vincent RN, Mahle WT. Cost-effectiveness of pediatric heart transplantation. J Heart Lung Transplant. 2006 Apr;25(4):409-15. doi: 10.1016/j.healun.2005.11.443. Epub 2006 Feb 8.
PubMed 16563970Wagner K, Oliver MC, Boyle GJ, Miller SA, Law YM, Pigula F, Webber SA. Endomyocardial biopsy in pediatric heart transplant recipients: a useful exercise? (Analysis of 1,169 biopsies). Pediatr Transplant. 2000 Aug;4(3):186-92. doi: 10.1034/j.1399-3046.2000.00100.x.
PubMed 10933318Johnson JN, Hornik CP, Li JS, Benjamin DK Jr, Yoshizumi TT, Reiman RE, Frush DP, Hill KD. Cumulative radiation exposure and cancer risk estimation in children with heart disease. Circulation. 2014 Jul 8;130(2):161-7. doi: 10.1161/CIRCULATIONAHA.113.005425. Epub 2014 Jun 9.
PubMed 24914037Andreassi MG, Ait-Ali L, Botto N, Manfredi S, Mottola G, Picano E. Cardiac catheterization and long-term chromosomal damage in children with congenital heart disease. Eur Heart J. 2006 Nov;27(22):2703-8. doi: 10.1093/eurheartj/ehl014. Epub 2006 May 22.
PubMed 16717079Ait-Ali L, Andreassi MG, Foffa I, Spadoni I, Vano E, Picano E. Cumulative patient effective dose and acute radiation-induced chromosomal DNA damage in children with congenital heart disease. Heart. 2010 Feb;96(4):269-74. doi: 10.1136/hrt.2008.160309. Epub 2009 Aug 16.
PubMed 19687017Beels L, Bacher K, De Wolf D, Werbrouck J, Thierens H. gamma-H2AX foci as a biomarker for patient X-ray exposure in pediatric cardiac catheterization: are we underestimating radiation risks? Circulation. 2009 Nov 10;120(19):1903-9. doi: 10.1161/CIRCULATIONAHA.109.880385. Epub 2009 Oct 26.
PubMed 19858412Singh V, Mendirichaga R, Savani GT, Rodriguez A, Blumer V, Elmariah S, Inglessis-Azuaje I, Palacios I. Comparison of Utilization Trends, Indications, and Complications of Endomyocardial Biopsy in Native Versus Donor Hearts (from the Nationwide Inpatient Sample 2002 to 2014). Am J Cardiol. 2018 Feb 1;121(3):356-363. doi: 10.1016/j.amjcard.2017.10.021. Epub 2017 Oct 31.
PubMed 29197471Subherwal S, Kobashigawa JA, Cogert G, Patel J, Espejo M, Oeser B. Incidence of acute cellular rejection and non-cellular rejection in cardiac transplantation. Transplant Proc. 2004 Dec;36(10):3171-2. doi: 10.1016/j.transproceed.2004.10.048.
PubMed 15686721Parsai C, O'Hanlon R, Prasad SK, Mohiaddin RH. Diagnostic and prognostic value of cardiovascular magnetic resonance in non-ischaemic cardiomyopathies. J Cardiovasc Magn Reson. 2012 Aug 2;14(1):54. doi: 10.1186/1532-429X-14-54.
PubMed 22857649Piehler KM, Wong TC, Puntil KS, Zareba KM, Lin K, Harris DM, Deible CR, Lacomis JM, Czeyda-Pommersheim F, Cook SC, Kellman P, Schelbert EB. Free-breathing, motion-corrected late gadolinium enhancement is robust and extends risk stratification to vulnerable patients. Circ Cardiovasc Imaging. 2013 May 1;6(3):423-32. doi: 10.1161/CIRCIMAGING.112.000022. Epub 2013 Apr 18.
PubMed 23599309
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac MRI Increases Accuracy and Decreases Risk of Evaluation of Children With Cardiomyopathy and Cardiac Transplantation
- ClinicalTrials.gov ID
- NCT03822442
- Acronym / sponsor ID
- 11408
- Keywords
- Cardiomyopathy, cardiomegaly, cardiac transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 30 Jan 2019 (actual)
- 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.
Overall Research Strategy of this protocol is to refine and validate noninvasive CMR imaging sequences with invasive hemodynamic and pathology results to create a comprehensive, noninvasive, radiation-reduced regimen for pediatric cardiomyopathy and cardiac transplant assessment. We were the first to perform MR-guided cardiac catheterization in US children, and have accumulated the largest US experience, having performed over 75 procedures to date. Our unique experience puts us in strong position to leverage this technology to improve care of children with cardiomyopathy and transplant. Using an integrated approach, we will simultaneously (1) validate imaging measures of cardiac edema and fibrosis by correlating T1 and T2 map images with endomyocardial biopsy (EMB) results in Aim 1; (2) overlay T1, T2 map images into our x-ray system to display "hotspots" of T1 and T2 abnormalities to guide EMB in Aim 2; and (3) obtain radiation-free hemodynamic data in a highly vulnerable pediatric population by using CMR to guide catheter manipulation in the ICMR suite in Aim 3.
Age and diagnosis-matched historical controls will be identified from the last 10 years at Children's National as a control population for specific purposes of comparing (1) EMB yield without image overlay and (2) Radiation exposure during X-ray guided right heart catheterization. Identical information will be obtained and stored in the same 45CFR compliant database. Historical controls will be identified from the cardiac catheterization database by searching for age and diagnosis. A waiver of consent will be applicable here, as it would be inconvenient, insensitive and not feasible to consent families who have already undergone treatment.
Detailed description
Anesthesia and Vascular Access After final review of protocol eligibility and of MRI safety, vascular access is obtained and sheaths are secured and covered with a sterile drape for transfer to the MRI. The catheterization is performed with continuous recording of electrocardiogram signals, transcutaneous hemoglobin ("pulse") oximetry, and under direct observation of an anesthesia licensed independent provider.
Diagnostic Cardiac MRI Before MRI catheterization begins, a focused cardiac MRI is performed to understand cardiac function and localize the proposed catheter trajectory from the access site into the targeted cardiovascular chambers.
MRI-guided catheterization Next during real-time MRI, a passive catheter is advanced from the access site into the targeted cardiovascular chambers under imaging guidance. Hemodynamic measurements (using fluid-filled transducers connected to the catheters) and blood hemoglobin saturation specimens are obtained from targeted cardiovascular chambers. Additional clinically-indicated and, if time allows, up to 30 minutes of research MRI is then performed before the subject is returned to the X-ray system.
Research MR Imaging Additional research cardiac MRI imaging to determine T1 and T2 values is undertaken next, with 6 short axis slices and one long axis slice positions identified for T1 map and T2 map acquisitions. The ICMR laboratory has a robust experience with acquisition of parametric mapping sequences. T1 and T2 maps will provide a roadmap for the cardiac biopsy that the patient requires in the xray suite.
Image Fusion to Guide Endomyocardial Biopsy At the conclusion of the MR imaging and MR-guided right heart catheterization procedure, the subject is returned to the X-ray suite for cardiac biopsy. Some cardiac biopsies are obtained in the usual fashion, and some biopsy specimens are obtained using image overlay software to display the regions of abnormal T1 and T2 onto the fluoroscopy system.
Conclusion of the procedure Following standard of care EMB, standard of care coronary angiography is obtained when if clinically indicated, all catheters and sheaths are removed and the subject is observed for complications in the cardiac procedure recovery unit or intensive care unit for at least 6 hours.
Diagnostic Echocardiogram Standard clinical data with strain analysis will be collected from the echocardiogram that is performed as a standard of care. Patients undergo a clinically indicated echocardiogram exam following the catheterization procedure in the Cardiac Post Recovery Unit (CPRU).
Blood Tests Serum for creatinine blood test will be collected at the time the clinically indicated IV is placed. Creatinine Is the standard test used at Children's National to assess kidney function. A total of 1cc of blood will be drawn to complete the test.
For subjects who consent to the optional study, an additional 5cc of blood work will be drawn at the time that the intravascular catheter is inserted for the clinically indicated cardiac catheterization procedure. The blood samples will be identified with the study ID number only, and will be stored in a secure freezer owned and maintained by the department of cardiology located at the Sheikh Zayed campus. This blood will be used to identify serum biomarkers, and to validate the potential use for diagnostic purposes.
Follow-up procedures At the conclusion of the procedure, the subject is returned to the X-ray table and all catheters are removed. The subject is observed for complications in an advanced nursing recovery unit or intensive care unit for at least 6 hours. The subject will be assessed for early and late complications at the time of discharge, and again approximately 2-6 weeks ± 7 days post procedure.
MRI Image Analysis In all cardiomyopathy and heart transplant patients, T1 measurements will be performed using offline analysis software according to our laboratory's measurement SOP for parametric maps. In heart transplant patients only, T2 measurements will be performed according to our laboratory's measurement SOP for parametric maps. Following measurements, images will be created for Image Overlay onto the fluoroscopy for patients undergoing clinically-indicated cardiac biopsy following the catheterization.
Biopsy Sample Analysis All biopsy samples will be evaluated clinically for evidence of cellular rejection, and a clinical report will be generated per clinical standard of care. In addition, each of the samples will undergo a separate staining procedure to identify regions of fibrosis. Digital images will be taken of the stained samples. Image processing software will be used to quantify percent fibrosis.
Historical Controls (for radiation exposure comparison, and biopsy yield comparison) Age and diagnosis-matched historical controls will be identified from the last 10 years at Children's National as a control population for specific purposes of comparing (1) EMB yield without image overlay and (2) Radiation exposure during X-ray guided right heart catheterization. Identical information will be obtained and stored in the same 45CFR compliant database. Historical controls will be identified from the cardiac catheterization database by searching for age and diagnosis. A waiver of consent will be applicable here, as it would be inconvenient, insensitive and not feasible to consent families who have already undergone treatment.
Subjects will not be provided additional information as a result of this research study.
Data will be reviewed in aggregate generating generalizable knowledge not applicable to an individual subject
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals referred to Children's National Medical Center with heart transplant or cardiomyopathy (i.e. "pre-transplant") to undergo clinically-indicated cardiac catheterization will be considered candidates for inclusion.
Key inclusion criteria (2 listed)
- Children and adults of any age with heart transplant, suspected or confirmed cardiomyopathy
- Undergoing clinically-indicated ("medically necessary") cardiovascular catheterization
Key exclusion criteria (15 listed)
- Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support.
- Women who are pregnant
- Women who are nursing and who do not plan to discard breast milk for 24 hours
- The eGFR will be used to estimate renal function if reported by the laboratory.
- The Schwartz equation 33 for estimation of GFR in children as recommended by the NKDEP is as follows:
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
Correlate MRI imaging results to biopsy results Correlate MRI imaging with endomyocardial biopsy
Time frame: At the end of each catheterization procedure through study completion,up to 5 years
Correlate MRI imaging sequences that can detect inflammation and fibrosis to quantities of inflammation and fibrosis seen on biopsy specimens taken from the same region.
2 secondary outcomes
Compare yield of biopsy specimen collection using x-ray vs x-ray fused MRI images
Time frame: At the end of each catheterization procedure through study completion,up to 5 years
Radiation exposure
Time frame: At the end of each catheterization procedure through study completion,up to 5 years
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 31 Mar 2026.
- Background: PubMed 19808316Hsu DT, Pearson GD. Heart failure in children: part I: history, etiology, and pathophysiology. Circ Heart Fail. 2009 Jan;2(1):63-70. doi: 10.1161/CIRCHEARTFAILURE.108.820217. No abstract available.
- Background: PubMed 28912187Lee TM, Hsu DT, Kantor P, Towbin JA, Ware SM, Colan SD, Chung WK, Jefferies JL, Rossano JW, Castleberry CD, Addonizio LJ, Lal AK, Lamour JM, Miller EM, Thrush PT, Czachor JD, Razoky H, Hill A, Lipshultz SE. Pediatric Cardiomyopathies. Circ Res. 2017 Sep 15;121(7):855-873. doi: 10.1161/CIRCRESAHA.116.309386.
- Background: PubMed 24180540Lipshultz SE, Cochran TR, Briston DA, Brown SR, Sambatakos PJ, Miller TL, Carrillo AA, Corcia L, Sanchez JE, Diamond MB, Freundlich M, Harake D, Gayle T, Harmon WG, Rusconi PG, Sandhu SK, Wilkinson JD. Pediatric cardiomyopathies: causes, epidemiology, clinical course, preventive strategies and therapies. Future Cardiol. 2013 Nov;9(6):817-48. doi: 10.2217/fca.13.66.
- Background: PubMed 28912179McKenna WJ, Maron BJ, Thiene G. Classification, Epidemiology, and Global Burden of Cardiomyopathies. Circ Res. 2017 Sep 15;121(7):722-730. doi: 10.1161/CIRCRESAHA.117.309711.
- Background: PubMed 26139361Badano LP, Miglioranza MH, Edvardsen T, Colafranceschi AS, Muraru D, Bacal F, Nieman K, Zoppellaro G, Marcondes Braga FG, Binder T, Habib G, Lancellotti P; Document reviewers. European Association of Cardiovascular Imaging/Cardiovascular Imaging Department of the Brazilian Society of Cardiology recommendations for the use of cardiac imaging to assess and follow patients after heart transplantation. Eur Heart J Cardiovasc Imaging. 2015 Sep;16(9):919-48. doi: 10.1093/ehjci/jev139. Epub 2015 Jul 2.
- Background: PubMed 16563970Dayton JD, Kanter KR, Vincent RN, Mahle WT. Cost-effectiveness of pediatric heart transplantation. J Heart Lung Transplant. 2006 Apr;25(4):409-15. doi: 10.1016/j.healun.2005.11.443. Epub 2006 Feb 8.
- Background: PubMed 10933318Wagner K, Oliver MC, Boyle GJ, Miller SA, Law YM, Pigula F, Webber SA. Endomyocardial biopsy in pediatric heart transplant recipients: a useful exercise? (Analysis of 1,169 biopsies). Pediatr Transplant. 2000 Aug;4(3):186-92. doi: 10.1034/j.1399-3046.2000.00100.x.
- Background: PubMed 24914037Johnson JN, Hornik CP, Li JS, Benjamin DK Jr, Yoshizumi TT, Reiman RE, Frush DP, Hill KD. Cumulative radiation exposure and cancer risk estimation in children with heart disease. Circulation. 2014 Jul 8;130(2):161-7. doi: 10.1161/CIRCULATIONAHA.113.005425. Epub 2014 Jun 9.
- Background: PubMed 16717079Andreassi MG, Ait-Ali L, Botto N, Manfredi S, Mottola G, Picano E. Cardiac catheterization and long-term chromosomal damage in children with congenital heart disease. Eur Heart J. 2006 Nov;27(22):2703-8. doi: 10.1093/eurheartj/ehl014. Epub 2006 May 22.
- Background: PubMed 19687017Ait-Ali L, Andreassi MG, Foffa I, Spadoni I, Vano E, Picano E. Cumulative patient effective dose and acute radiation-induced chromosomal DNA damage in children with congenital heart disease. Heart. 2010 Feb;96(4):269-74. doi: 10.1136/hrt.2008.160309. Epub 2009 Aug 16.
- Background: PubMed 19858412Beels L, Bacher K, De Wolf D, Werbrouck J, Thierens H. gamma-H2AX foci as a biomarker for patient X-ray exposure in pediatric cardiac catheterization: are we underestimating radiation risks? Circulation. 2009 Nov 10;120(19):1903-9. doi: 10.1161/CIRCULATIONAHA.109.880385. Epub 2009 Oct 26.
- Background: PubMed 29197471Singh V, Mendirichaga R, Savani GT, Rodriguez A, Blumer V, Elmariah S, Inglessis-Azuaje I, Palacios I. Comparison of Utilization Trends, Indications, and Complications of Endomyocardial Biopsy in Native Versus Donor Hearts (from the Nationwide Inpatient Sample 2002 to 2014). Am J Cardiol. 2018 Feb 1;121(3):356-363. doi: 10.1016/j.amjcard.2017.10.021. Epub 2017 Oct 31.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Laura Olivieri, MD principal investigator
Children's National Research Institute
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 Heart Failure and Cardiac Imaging Techniques, run by Children's National Research Institute 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 2 inclusion and 15 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 31 Mar 2026. 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?
Correlate MRI imaging results to biopsy results Correlate MRI imaging with endomyocardial biopsy (time frame: At the end of each catheterization procedure through study completion,up to 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 NCT03822442, which also lists 26 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 31 Mar 2026.