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Cardiopulmonary Function in Adults Born With a Ventricular Septal Defect

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03684161
Recruitment Status : Completed
First Posted : September 25, 2018
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
The overall objective for this study is to evaluate the cardiopulmonary function of VSD-patients compared with healthy age- and gender-matched controls. VSD patients with a surgically corrected defect and VSD patients with a small persistent defect will be included.

Condition or disease Intervention/treatment
Ventricular Septal Defect Diagnostic Test: Cardiopulmonary function

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cardiopulmonary Function in Adults Born With a Ventricular Septal Defect
Actual Study Start Date : September 24, 2018
Actual Primary Completion Date : August 12, 2019
Actual Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Surgically closed VSDs
Patients born with a ventricular septal defect, which have been closed in early childhood.
Diagnostic Test: Cardiopulmonary function
Body composition measurements; Pulmonary function tests; Cardiopulmonary exercise test; Force frequency releationship, ultrasound

Small, persistent VSDs
Patients born with a small, hemodynamically insignificant ventricular septal defect.
Diagnostic Test: Cardiopulmonary function
Body composition measurements; Pulmonary function tests; Cardiopulmonary exercise test; Force frequency releationship, ultrasound

Healthy controls
Healthy control subjects.
Diagnostic Test: Cardiopulmonary function
Body composition measurements; Pulmonary function tests; Cardiopulmonary exercise test; Force frequency releationship, ultrasound




Primary Outcome Measures :
  1. Peak oxygen uptake [ Time Frame: One week. ]
    (ml O2/kg/min)


Secondary Outcome Measures :
  1. Forced expiratory volume in one second (FEV1) [ Time Frame: One week. ]
    (L)

  2. Peak isovolumetric acceleration during exercise [ Time Frame: One year. ]
    (cm/s2)

  3. Airway resistance [ Time Frame: One week. ]
    (x)

  4. Diffusion capacity for carbon monoxide [ Time Frame: One week. ]
    (x)

  5. Health-related quality of life [ Time Frame: Post hoc evaluation. 1 year. ]
    (Questionnaire)

  6. Peak heart rate during exercise [ Time Frame: One week. ]
    (beats/min)



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of three groups; a group of small unrepaired VSDs, a group of surgically corrected VSDs and a group of healthy, age-matched controls. Each group is aimed at including 20 participants.
Criteria

Inclusion:

  • Patients born between 1938 and 1978.
  • Patients registered with DX Q21.0, and if the defect is unrepaired in accordance with criteria from the ESC guidelines 5 or is repaired as documented by the procedural code KFHB.

Recruitment of healthy control subjects will take place by means of adverts at the website www.forsoegspersoner.dk. Control subjects will be matched by likewise age-groups.

Exclusion:

  • Lack of medical record
  • Serious congenital cardiac abnormalities
  • Lack of Danish language skills
  • Severe lung or heart disease
  • Syndromes, such as Down's
  • Mentally or physically incompetent to perform the tests.

Participants will be informed of the exclusion criteria at the initial information interview before inclusion in the study. Oral verification is considered sufficient to verify the exclusion criteria.


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): NCT03684161


Locations
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Denmark
Department of Cardiothoracic and Vascular Surgery
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Vibeke E Hjortdal, MD, PhD, DMSc Dept. of Cardiothoracic and Vascular Surgery

Publications:
Selskab DC. Anbefalinger for standardiseret minimumskrav til transthorakal ekkokardiografi hos voksne. In: Selskab DC, ed. Dansk Cardiologisk Selskab DCS: DCS, 2008.

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03684161     History of Changes
Other Study ID Numbers: FEMM4
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Congenital Heart Disease
Ventricular Septal Defect
Long-term Outcome
Cardiopulmonary Function
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities