1 |
NCT01952171 |
Recruiting |
The Genetic Basis of Congenital Heart Disease in Africa |
- Congenital Heart Disease
- Heart Disease
|
|
Observational |
|
- National Human Genome Research Institute (NHGRI)
- University of Lagos, Nigeria
- Uganda Heart Institute, Kampala, Uganda
- National Institutes of Health Clinical Center (CC)
|
NIH / Other |
- Observational Model: Cohort
- Time Perspective: Other
|
- Determine, identify, and estimate the prevalence of novel and known CHD causing mutation in African populations
- Characterize the genetic architecture of Congenital Heart Disease (CHD) using genomic approaches in Africa
- Understand CHD gene function in cardiac development
|
2500 |
All |
Child, Adult, Senior |
NCT01952171 |
999913207 13-HG-N207 |
|
September 24, 2013 |
September 1, 2018 |
September 1, 2018 |
September 27, 2013 |
March 12, 2018 |
|
- Narayana Health City
Bengaluru, India - Kasturba Medical College and Hospital
Manipal, India - University of Lagos
Lagos, Nigeria - (and 2 more...)
|
2 |
NCT01192048 |
Recruiting |
Genetics of Congenital Heart Disease |
|
- Other: Blood Sample Collection
|
Observational |
|
- Nationwide Children's Hospital
- National Heart, Lung, and Blood Institute (NHLBI)
|
Other / NIH |
- Observational Model: Family-Based
- Time Perspective: Prospective
|
- Identification of novel genetic contributors to congenital heart defects
|
1000 |
All |
Child, Adult, Senior |
NCT01192048 |
IRB09-00339 R01HL109758-03 |
|
December 2009 |
December 2025 |
December 2025 |
August 31, 2010 |
February 27, 2018 |
|
- Nationwide Children's Hospital
Columbus, Ohio, United States
|
3 |
NCT01196182 |
Recruiting |
Congenital Heart Disease GEnetic NEtwork Study (CHD GENES) |
|
|
Observational |
|
- Children's Hospital Medical Center, Cincinnati
- National Heart, Lung, and Blood Institute (NHLBI)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
10000 |
All |
up to 99 Years (Child, Adult, Senior) |
NCT01196182 |
701 5U01HL098188-03 U01HL098188 U01HL098147 U01HL098163 U01HL098153 U01HL098123 U01HL098162 |
CHD GENES |
November 2010 |
July 2020 |
July 2020 |
September 8, 2010 |
April 5, 2017 |
|
- Children's Hospital Los Angeles
Los Angeles, California, United States - Stanford University
Palo Alto, California, United States - University of California, San Francisco
San Francisco, California, United States - (and 10 more...)
|
4 |
NCT03023644 |
Recruiting |
Improving Neurodevelopmental Outcomes in Children With Congenital Heart Disease: An Intervention Study |
- Congenital Heart Defect
- Executive Function
- Children
- (and 3 more...)
|
- Behavioral: Cogmed Working Memory Training
|
Interventional |
Not Applicable |
- Boston Children’s Hospital
- United States Department of Defense
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Other
|
- Change from baseline scores at the computerized Working Memory Test from the NIH Toolbox Assessment of Neurological and Behavioral Function at post-treatment assessment
|
100 |
All |
7 Years to 12 Years (Child) |
NCT03023644 |
IRB-P00022440 |
|
February 21, 2017 |
February 20, 2019 |
September 30, 2019 |
January 18, 2017 |
March 23, 2018 |
|
- Boston Children's Hospital
Boston, Massachusetts, United States
|
5 |
NCT03070197 |
Recruiting |
Genomic Basis of Neurodevelopmental and Brain Outcomes in Congenital Heart Disease (CHD Brain and Genes) |
|
- Other: Exposure of interest: Brain MRI
- Other: Exposure of interest: neurodevelopmental assessments
|
Observational |
|
- Children's Hospital Medical Center, Cincinnati
- National Heart, Lung, and Blood Institute (NHLBI)
|
Other / NIH |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Neurodevelopment and behavioral health assessment
- Abnormalities in brain structure and microstructure on MRI
|
400 |
All |
8 Years and older (Child, Adult, Senior) |
NCT03070197 |
2016-6315 5U01HL131003-02 |
|
September 18, 2017 |
December 2022 |
December 2022 |
March 3, 2017 |
February 13, 2018 |
|
- Children's Hospital Los Angeles
Los Angeles, California, United States - University of California, San Francisco
San Francisco, California, United States - Yale University
New Haven, Connecticut, United States - (and 5 more...)
|
6 |
NCT03073122 |
Recruiting |
The Boston Circulatory Arrest Study: Antecedents and Correlates of Well-Being in Adults With Congenital Heart Disease |
- Transposition Great Arteries
- Executive Dysfunction
|
- Diagnostic Test: Brain MRI, neurocognitive and psychological testing
|
Observational |
|
- Boston Children’s Hospital
- National Heart, Lung, and Blood Institute (NHLBI)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Quality of Life
- Mental health - Anxiety
- Mental Health - Depression
- (and 9 more...)
|
150 |
All |
24 Years to 30 Years (Adult) |
NCT03073122 |
P00023574 1R01HL135061-01 |
BCAS-Adult |
November 9, 2017 |
June 30, 2020 |
October 2020 |
March 8, 2017 |
January 31, 2018 |
|
- Boston Children's Hospital
Boston, Massachusetts, United States
|
7 |
NCT03152773 |
Recruiting |
Right Heart Catheterization Using Magnetic Resonance Imaging Fluoroscopy and Passive Guidewires |
- Pulmonary Artery Hypertension
- Congenital Heart Disease
|
- Procedure: MRI Right Heart guidewire catheterization
|
Interventional |
Phase 1 Phase 2 |
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- To test the safety of performing right heart catheterization with a Terumo Glidewire guided by low-SAR MRI fluoroscopy
- To test in vivo human conspicuity of the glidewire using off-resonance MR image reconstruction.
|
50 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT03152773 |
170095 17-H-0095 |
|
August 2, 2017 |
May 1, 2019 |
May 1, 2019 |
May 15, 2017 |
April 17, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
8 |
NCT01287026 |
Recruiting |
Real-time MRI Right Heart Catheterization Using Passive Catheters |
- Caridovascular Disease
- Congenital Heart Disease
- Pulmonary Hypertension
|
- Device: Balloon catheter for right heart catheterization
- Drug: Gadopentate Dimeglumine (Gadolinium); Contrast Agent
- Procedure: Right Heart Catheterization
- (and 2 more...)
|
Interventional |
Phase 1 |
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- To test the initial safety and feasibility of diagnostic right heart catheterization in human subjects using MRI-guidance and "passive" catheters
- To train staff in the conduct of simple MRI catheterization in humans, to accrue incremental experience towards more complex MRI catheterization procedures
- To test incremental MRI scanning techniques (technical developments) to assist MRI catheterization in humans
|
150 |
All |
2 Years and older (Child, Adult, Senior) |
NCT01287026 |
110091 11-H-0091 |
|
January 25, 2011 |
December 28, 2018 |
December 28, 2018 |
February 1, 2011 |
April 23, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
9 |
NCT03013751 |
Recruiting |
A Extension Study of Udenafil in Adolescents |
- Functional Single Ventricle Heart Disease
|
|
Interventional |
Phase 3 |
- Mezzion Pharma Co. Ltd
- National Heart, Lung, and Blood Institute (NHLBI)
|
Industry / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety (Adverse Events)
- Exercise (Change in maximal oxygen consumption)
- Echo (Change in myocardial performance Index)
- (and 3 more...)
|
300 |
All |
12 Years to 18 Years (Child, Adult) |
NCT03013751 |
PHN-Udenafil-03 U01HL068270 |
FUELExten |
January 2017 |
February 2019 |
February 2019 |
January 6, 2017 |
March 14, 2018 |
|
- Phoenix Children's Hospital/Children's Heart Center at Phoenix Children's Hospital
Phoenix, Arizona, United States - Cedars/Sinai Heart Institute
Los Angeles, California, United States - Rady Children's Hospital
San Diego, California, United States - (and 21 more...)
|
10 |
NCT02315898 |
Recruiting |
Inhaled Tissue Plasminogen Activator for Acute Plastic Bronchitis |
- Plastic Bronchitis
- Protein-Losing Enteropathies
- Healthy
|
- Drug: Treatment-inhaled tPA
|
Interventional |
Phase 2 |
- University of Michigan
- Food and Drug Administration (FDA)
- Genentech, Inc.
|
Other / U.S. Fed / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Primary Endpoint: Number of subjects that develop new, active bleeding
- Arterial oxygen saturation
- Forced expiratory volume in one second (FEV1)
- (and 9 more...)
|
24 |
All |
5 Years to 18 Years (Child, Adult) |
NCT02315898 |
UMich Inhaled tPA119678 R01FD005393 |
PLATyPuS |
March 19, 2018 |
August 2021 |
December 2021 |
December 12, 2014 |
March 21, 2018 |
|
- Lucile Packard Children's Hospital, Stanford University
Palo Alto, California, United States - Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States - University of Michigan Mott Children's Hospital
Ann Arbor, Michigan, United States - (and 3 more...)
|
11 |
NCT02919956 |
Recruiting |
Cerebral Anatomy, Hemodynamics and Metabolism |
- Hypoplastic Left Heart Syndrome
|
- Other: Magnetic Resonance Imaging
- Other: Neurodevelopmental Testing
|
Observational |
|
- Children's Hospital of Philadelphia
- National Heart, Lung, and Blood Institute (NHLBI)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Relationship of CBF and Brain Abnormalities to ND Outcomes
- Relationship of CMRO2 to ND outcome
|
150 |
All |
Child, Adult, Senior |
NCT02919956 |
15-012291 5R01HL090615-07 |
|
April 2016 |
June 2019 |
June 2019 |
September 30, 2016 |
October 3, 2017 |
|
- Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
|
12 |
NCT00001721 |
Recruiting |
Study of Smith-Lemli-Opitz Syndrome |
- Abnormalities
- Inborn Errors of Metabolism
- Mental Retardation
- (and 2 more...)
|
|
Observational |
|
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
200 |
All |
Child, Adult, Senior |
NCT00001721 |
980081 98-CH-0081 |
|
March 23, 1998 |
|
|
November 4, 1999 |
April 17, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
13 |
NCT03331380 |
Recruiting |
Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System |
|
- Device: MRI scan x 1- Healthy volunteer
- Device: MRI scan x 2- Healthy volunteer
- Device: MRI scan x 2- CAD patients
- Device: MRI scan x 2- non-CAD patients
|
Interventional |
Phase 1 Phase 2 |
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Technical feasibility and Non-inferiority of the above measurements and examinations obtained using low SAR CMR versus commercial CMR in healthy volunteers and in patients with heart disease
- Numerous exploratory secondary endpoints are sought around the listed measurements across MRI systems and disease states
|
460 |
All |
18 Years and older (Adult, Senior) |
NCT03331380 |
180011 18-H-0011 |
|
January 5, 2018 |
May 30, 2018 |
May 30, 2019 |
November 6, 2017 |
April 17, 2018 |
|
- National Institutes of Health Clinical Center
Bethesda, Maryland, United States
|
14 |
NCT00733590 |
Recruiting |
Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention |
- Heart Failure, Congestive
- Death, Sudden, Cardiac
- Arrhythmia
- Cardiomyopathies
|
|
Observational |
|
- Johns Hopkins University
- University of Maryland
- Washington Hospital Center
- (and 2 more...)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Arrhythmic Sudden Death defined as a therapy from the ICD for rapid VT or VF or a ventricular arrhythmia not corrected by the ICD
- All cause mortality, CV mortality, heart transplant, LVAD, and ICD explantation or ICD Disabled
|
1500 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT00733590 |
NA_00045142 5R01HL091062 |
PROSe-ICD |
June 2003 |
March 2020 |
March 2020 |
August 13, 2008 |
August 14, 2017 |
|
- Washington Hospital Center
Washington, D.C., District of Columbia, United States - University of Maryland Medical Center
Baltimore, Maryland, United States - Johns Hopkins University School of Medicine
Baltimore, Maryland, United States - Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States
|
15 |
NCT03430583 |
Recruiting |
Evaluation of Fontan-Associated Liver Disease |
- Single Ventricle Heart Disease
|
|
Observational |
|
- Mezzion Pharma Co. Ltd
- National Heart, Lung, and Blood Institute (NHLBI)
|
Industry / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Range of Liver Stiffness in Adolescents with Single Ventricle Heart Disease
- Effect of Drug Therapy on Liver Stiffness
- Effect of Drug Therapy on Brain Type Natriuretic Peptide (BNP) Levels
- (and 3 more...)
|
100 |
All |
12 Years and older (Child, Adult, Senior) |
NCT03430583 |
PHN-Udenafil-04 U01HL068270 |
FALD |
February 20, 2018 |
July 30, 2020 |
December 31, 2020 |
February 13, 2018 |
March 14, 2018 |
|
- Children's Hospital Colorado
Aurora, Colorado, United States - Nemours Cardiac Center/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States - Children's National Medical Center
Washington, District of Columbia, United States - (and 13 more...)
|
16 |
NCT02109575 |
Recruiting |
Quantitative Detection of Circulating Donor-Specific DNA in Organ Transplant Recipients (DTRT-Multi-Center Study) |
- Cardiovascular Disease
- Acute Rejection of Cardiac Transplant
- Cardiac Transplant Rejection
- Heart Transplant Failure and Rejection
|
- Diagnostic Test: Blood Draw of up to 10 ml
|
Observational |
|
- Medical College of Wisconsin
- National Heart, Lung, and Blood Institute (NHLBI)
- Columbia University
- (and 6 more...)
|
Other / NIH / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Assay and laboratory protocol development and optimization.
- Biomarker Development
|
480 |
All |
Child, Adult, Senior |
NCT02109575 |
CHW 10/83 R01HL119747 |
DTRT |
September 2013 |
May 2018 |
May 2018 |
April 10, 2014 |
March 27, 2017 |
|
- Arkansas Children's Hospital
Little Rock, Arkansas, United States - Emory University
Atlanta, Georgia, United States - Lurie Children's Hospital
Chicago, Illinois, United States - (and 5 more...)
|