Cardiopulmonary Function in Adults Born With a Ventricular Septal Defect

NCT03684161 | Completed

• 1 other identifier: FEMM4
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Septal Defect

Keywords

Congenital Heart Disease; Ventricular Septal Defect; Long-term Outcome; Cardiopulmonary Function

Outcome Measures

Primary Outcomes (1)

• Peak oxygen uptake

  (ml O2/kg/min)

  One week.

Secondary Outcomes (6)

• Forced expiratory volume in one second (FEV1)

  One week.

• Peak isovolumetric acceleration during exercise

  One year.

• Airway resistance

  One week.

• Diffusion capacity for carbon monoxide

  One week.

• Health-related quality of life

  Post hoc evaluation. 1 year.

Study Arms (3)

Surgically closed VSDs

Patients born with a ventricular septal defect, which have been closed in early childhood.

Diagnostic Test: Cardiopulmonary function

Small, persistent VSDs

Patients born with a small, hemodynamically insignificant ventricular septal defect.

Diagnostic Test: Cardiopulmonary function

Healthy controls

Healthy control subjects.

Diagnostic Test: Cardiopulmonary function

Interventions

Cardiopulmonary function DIAGNOSTIC_TEST

Body composition measurements; Pulmonary function tests; Cardiopulmonary exercise test; Force frequency releationship, ultrasound

Healthy controls; Small, persistent VSDs; Surgically closed VSDs

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Cardiothoracic and Vascular Surgery

Aarhus C, 8000, Denmark

Location

Related Publications (32)

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  BACKGROUND

• Brun H, Moller T, Fredriksen PM, Thaulow E, Pripp AH, Holmstrom H. Mechanisms of exercise-induced pulmonary hypertension in patients with cardiac septal defects. Pediatr Cardiol. 2012 Jun;33(5):782-90. doi: 10.1007/s00246-012-0216-9. Epub 2012 Mar 1.

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• Maagaard M, Eckerstrom F, Schram AL, Jensen HAR, Hjortdal V. Health and Well-Being in Older Adults With a Surgically Closed or an Unrepaired Ventricular Septal Defect. J Am Heart Assoc. 2023 Aug 15;12(16):e028538. doi: 10.1161/JAHA.122.028538. Epub 2023 Aug 7.

  PMID: 37548158 DERIVED

• Eckerstrom F, Maagaard M, Boutrup N, Hjortdal VE. Pulmonary Function in Older Patients With Ventricular Septal Defect. Am J Cardiol. 2020 Jun 1;125(11):1710-1717. doi: 10.1016/j.amjcard.2020.02.014. Epub 2020 Mar 13.

  PMID: 32291090 DERIVED

MeSH Terms

Conditions

Heart Septal Defects, Ventricular; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Septal Defects; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Vibeke E Hjortdal, MD, PhD, DMSc

  Dept. of Cardiothoracic and Vascular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 25, 2018
• Study Start: September 24, 2018
• Primary Completion: August 12, 2019
• Study Completion: September 1, 2019
• Last Updated: September 10, 2019

Record last verified: 2018-09

Locations

DK (1)