Clinical Trial: Cardiac Function After Transcatheter VSD Closure

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Changes in Ventricular Remodeling and Exercise Cardiopulmonary Function After Transcatheter Closure of Ventricular Septal Defect

Brief Summary:

With advances in interventional cardiac catheterization, ventricular septal defect (VSD) could be successfully treated via transcatheter device closure. Cardiac catheterization team of National Taiwan University Children's Hospital has recently treated more than 60 patients with VSD using this technique. Both treatment effect and follow-up results were encouraging. Of particular notice is that many patients experienced subjective improvement in exercise tolerance after VSD closure. Traditionally, VSD could only be repaired by open-heart surgery under cardiopulmonary bypass. Therefore, VSD closure would be considered only for those with moderate to large defect, significant heart failure, or presenting with significant exercise intolerance. With the success in transcatheter closure of VSD, a procedure which is safer and leading to faster recovery comparing to cardiac surgery, device closure of VSD would be a reasonable and sensible treatment of choice if it is beneficial for long-term cardiac function and exercise performance.

This project will prospectively enroll 50 patients with VSDs subject to transcatheter closure of the defect in our institute. Before device closure and 6 months after closure, participants will be assessed with image studies (including speckle tracking and tissue Doppler echocardiography), measurements of serum biomarkers (including B-type natriuretic peptide and biomarkers of collagen metabolism), and standard cardiopulmonary exercise test. The purpose of this study is to investigate the potential benefits of closing VSD with respect to cardiac function and exercise performance, which might serve as basis to redefine future indication of VSD closure.


Detailed Summary:

The investigators will enroll 50 consecutive patients with VSDs from the outpatient clinic of National Taiwan University Children's Hospital and Yi-Da Hospital. All participants will receive transcatheter VSD closure after comprehensive discussion with the clinical physicians and the performing clinicians. However, the investigators do not assign such treatment to the subjects of the study, and are not involved in treatment decision making. The inclusion criteria included:

  1. subject to transcatheter device closure of VSD (mostly using Amplatzer ductal occluder I and II for perimembranous VSD, and Amplatzer muscular VSD occluder for muscular VSD) based on clinical need;
  2. age between 12-60 years;

Patients with following conditions will be excluded:

  1. additional hemodynamically significant structural anomalies, including more than mild degree of VSD-related aortic regurgitation or right ventricular outflow tract obstruction;
  2. pulmonary hypertension documented during cardiac catheterization;
  3. musculoskeletal anomalies limiting the performance of exercise testing;
  4. taking cardiac medications within 6 months of enrollment;
  5. having alcohol abuse, coronary artery disease, systemic hypertension, diabetes mellitus, liver disease, renal insufficiency, metabolic bone disease, autoimmune disease, and received operation or having a history of trauma within 6 months of study enrollment.

All study participants will provide written informed consent, and the institutional review committee approved the s
Sponsor: National Taiwan University Hospital

Current Primary Outcome:

  • Changes in exercise capacity--peak oxygen consumption [ Time Frame: 6 months ]
    Changes in peak VO2 (% of predicted value)
  • Changes in exercise capacity--heart rate reserve [ Time Frame: 6 months ]
    Changes in heart rate reserve (beats per minute)
  • Changes in echocardiographic parameters-tissue Doppler imaging [ Time Frame: 6 months ]
    Tissue Doppler derived mitral systolic and diastolic velocities (cm/s)
  • Changes in echocardiographic parameters-strain and strain rate [ Time Frame: 6 months ]
    2D speckle tracking derived left ventricular longitudinal and circumferential strain (%) and strain rate (1/s)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in serum BNP level [ Time Frame: 6 months ]
    Changes in serum BNP level (pg/mL)
  • Changes in circulating fibrosis markers [ Time Frame: 6 months ]
    Changes in PICP (ng/mL)
  • Changes in circulating fibrosis markers [ Time Frame: 6 months ]
    Changes in CITP (ng/mL)
  • Changes in circulating fibrosis markers [ Time Frame: 6 months ]
    Changes in TIMP-1 (ng/mL)
  • Changes in circulating fibrosis markers [ Time Frame: 6 months ]
    Changes in MMP-9 (ng/mL)


Original Secondary Outcome: Same as current

Information By: National Taiwan University Hospital

Dates:
Date Received: June 21, 2015
Date Started: July 1, 2015
Date Completion: June 30, 2017
Last Updated: April 20, 2017
Last Verified: April 2017