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Long-term Outcomes and Vascular Evaluation After Coarctation of the Aorta Treatment (LOVE-COARCT)

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ClinicalTrials.gov Identifier: NCT03262753
Recruitment Status : Unknown
Verified August 2017 by Centro Hospitalar de Lisboa Central.
Recruitment status was:  Recruiting
First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Collaborators:
Centro de Estudos de Doenças Crónicas
Baylor College of Medicine
Lucile Packard Children's Hospital
Children's Hospital Colorado
University of Nebraska
Boston Children’s Hospital
Instituto Superior Técnico de Lisboa
Caselas, Ressonância Magnética, S.A.
Information provided by (Responsible Party):
Centro Hospitalar de Lisboa Central

Brief Summary:
Background: Coarctation of the aorta (CoA) can be treated using surgery, balloon angioplasty or stent implantation. Although short-term results are excellent with all three treatment modalities, long term cardiovascular (CV) morbidity and mortality remain high, likely due to persistently abnormal vascular function. The effects of treatment modality on long term vascular function remain uncharacterized. The goal of this study is to assess vascular function in this patient population for comparison among the treatment modalities. Methods: Vascular function in large and small arteries will be prospectively assessed fusing multiple non-invasive modalities, and the results will be compared among the three groups of CoA patients previously treated using surgery, balloon angioplasty or stent implantation after frequency matching for confounding variables. A comprehensive vascular function assessment protocol was created to be used in 7 centers. The primary outcome is arterial stiffness measured by arterial tonometry. Inclusion and exclusion criteria were carefully established after consideration of several potential confounders. Sample size was calculated for the primary outcome variable. Conclusions: Treatment modalities for CoA may have distinct impact on large and small arterial vascular function. The results of this study will help identify the treatment modality that is associated with the most optimal level of vascular function, which, in the long term may reduce CV risk.

Condition or disease Intervention/treatment
Aortic Coarctation Arterial Stiffness PULSE WAVE VELOCITY Functional Magnetic Resonance Imaging Vascular Endothelium Procedure: Surgery Procedure: Balloon dilation Procedure: Stent

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: LOVE-COARCT Study: Long-term Outcomes and Vascular Evaluation After Coarctation of the Aorta Treatment
Actual Study Start Date : June 1, 2013
Estimated Primary Completion Date : September 30, 2017
Estimated Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
surgery
Primary end-to-end surgical treatment of coarctation of the aorta
Procedure: Surgery
Primary end-to-end surgical treatment of coarctation of the aorta

balloon dilation
Primary balloon dilation treatment of coarctation of the aorta
Procedure: Balloon dilation
Primary balloon dilation treatment of coarctation of the aorta

stent
Primary stent dilation treatment of coarctation of the aorta
Procedure: Stent
Primary stent dilation treatment of coarctation of the aorta




Primary Outcome Measures :
  1. Vascular function [ Time Frame: 6 months to 35 years after primary treatment ]
    Arterial stiffness assessed with carotid-femoral PWV measurements by tonometry


Secondary Outcome Measures :
  1. Cardiac Magnetic Resonance functional indexes [ Time Frame: 6 months to 35 years after primary treatment ]
    Ascending-descending aorta PWV and aorta strain, distensibility, compliance and aortic stiffness β index measured by CMR

  2. Endothelial function [ Time Frame: 6 months to 35 years after primary treatment ]
    Endothelial function determined by endothelial pulse amplitude testing

  3. Pulse wave form [ Time Frame: 6 months to 35 years after primary treatment ]
    Pulse wave form analysis using arterial tonometry

  4. Blood pressure phenotype [ Time Frame: 6 months to 35 years after primary treatment ]
    Blood pressure phenotype at rest, during ambulatory measurement, and at peak exercise

  5. Left ventricular mass [ Time Frame: 6 months to 35 years after primary treatment ]
    Left ventricular mass assessed by Cardiac Magnetic Resonance

  6. Left ventricular systolic function [ Time Frame: 6 months to 35 years after primary treatment ]
    Left ventricular systolic function assessed by Cardiac Magnetic Resonance

  7. Biomarkers of endothelial function [ Time Frame: 6 months to 35 years after primary treatment ]
    biomarkers of endothelial function (total oxides of nitrogen- NOx and ADMA),

  8. Biomarkers of vascular inflammation [ Time Frame: 6 months to 35 years after primary treatment ]
    biomarkers of inflammation (hs-CRP).

  9. Biomarkers of vascular wall function [ Time Frame: 6 months to 35 years after primary treatment ]
    biomarkers of vascular wall function (VCAM-1 and IL-1β)

  10. Biomarkers of vascular remodeling [ Time Frame: 6 months to 35 years after primary treatment ]
    biomarkers of vascular remodeling (MMP-2; MMP-9 and TGF-beta1).



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Ages Eligible for Study:   8 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with isthmic coarctation of the aorta, treated after 1994, submitted to only one of either of the three procedures described above.
Criteria

Inclusion Criteria:

  • Diagnosis of isthmic coarctation of the aorta;
  • Current age between 8 (to allow cooperation with study procedures) and 35 years (to avoid confounding by aging-related vascular dysfunction); and
  • Treatment for CoA after 1994, after which all three modalities were in clinical use.

Exclusion Criteria:

  • Residual CoA defined by a systolic upper-to-lower extremity BP gradient> 20mmHg;
  • Co-morbidities that may independently affect vascular function, including associated significant congenital heart disease, history of known vasculopathy, genetic syndromes or other cardiovascular risk factors;
  • History of two treatment types for CoA; and
  • CoA types likely representing a different entity or patients amenable to one single treatment type (surgery), including atypical CoA site (such as mid-thoracic or abdominal), severe hypoplasia of the aortic arch, and an age of treatment <1 year of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262753


Contacts
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Contact: José D Martins, MD, MSc +351918338690 jose.martins@chlc.min-saude.pt
Contact: Centro de Investigação Centro Hospitalar de Lisboa Central +351213596481 centro.investigacao@chlc.min-saude.pt

Locations
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Portugal
Department of Pediatric Cardiology, Hospital de Santa Marta, Centro Hospitalar de Lisboa Central Recruiting
Lisboa, Portugal, 1169-024
Contact: José D Martins, MD MSc    +351918338690    jose.martins@chlc.min-saude.pt   
Sponsors and Collaborators
Centro Hospitalar de Lisboa Central
Centro de Estudos de Doenças Crónicas
Baylor College of Medicine
Lucile Packard Children's Hospital
Children's Hospital Colorado
University of Nebraska
Boston Children’s Hospital
Instituto Superior Técnico de Lisboa
Caselas, Ressonância Magnética, S.A.
Investigators
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Principal Investigator: José D Martins, MD MSc Centro Hospitalar de Lisboa Central
Study Chair: Miguel Mota Carmo, MD PhD Centro de Estudos de Doenças Crónicas da Faculdade de Ciências Médicas da Universidade Nova de Lisboa

Publications:
Walhout RJ. Assessment of proximal and distal aortic properties with magnetic resonance after successful coarctation management in adults. Advances in the management and surveillance of patients with aortic coarctation. 2009/06/26 ed: Universiteit Amsterdam; 2009. p. 122-30.
Colan SD. Normal echocardiographic values for cardiovascular structures. In: Lai WW, Cohen MS, Geva T, Mertens L, editors. Echocardiography in Pediatric and Congenital Heart Disease. West Sussex, UK: Wiley-Blackwell; 2009. p. Appendix 1, pp 765-85.

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Responsible Party: Centro Hospitalar de Lisboa Central
ClinicalTrials.gov Identifier: NCT03262753     History of Changes
Other Study ID Numbers: CHLC.CI.69.2012
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities