Study of RV Remodeling in Congenital Heart Disease

NCT02791061 | Unknown

• 1 other identifier: 2012/856/C
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aims of this study are to 1. Develop an automated method of quantitation of RV remodeling in terms of regional RV surface curvature and area strain and assess the feasibility, repeatability and accuracy in normal subjects and patients with repaired TOF, patients with PS The secondary study aims of this study are to 1\. Compare the differences of RV remodeling in repaired TOF patients, PS patients with sex and age-matched controls 2, Assess the relationship of our proposed parameters to global RV function and exercise capacity in repaired TOF patients and PS patient

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• First occurrence of cardiovascular event

  1 Year

Study Arms (2)

Control

Healthy Volunteers will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imagine (MRI) Cardiopulmonary exercise testing (CPET) Echocardiography

Other: Cardiovascular Magnetic Resonance Imagine (MRI); Other: Cardiopulmonary exercise testing (CPET); Other: Echocardiography

Congenital Disease

Patients will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imagine (MRI) Cardiopulmonary exercise testing (CPET) Echocardiography

Other: Cardiovascular Magnetic Resonance Imagine (MRI); Other: Cardiopulmonary exercise testing (CPET); Other: Echocardiography

Interventions

Cardiovascular Magnetic Resonance Imagine (MRI) OTHER

MRI uses interaction of the magnetic properties of body tissues with strong magnetic fields to create images.

Congenital Disease; Control

Cardiopulmonary exercise testing (CPET) OTHER

Cardiopulmonary exercise testing (CPET) is non-invasive simultaneous measurement of the cardiovascular and respiratory system during exercise to assess a patient's exercise capacity.

Congenital Disease; Control

Echocardiography OTHER

To measure heart chamber size, heart function, blood vessel size and blood vessel function. These measurements will help us understand the type and severity of heart failure.

Congenital Disease; Control

Eligibility Criteria

• Age: 13 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

34 patients diagnosed will Tetralogy of Fallots or Pulmonary Stenosis will be recruited from primary care clinic, outpatient clinics and hospital ward in NHCS. 20 Healthy Volunteer control group.

You may qualify if:

• Survivors of TOF repair more than one year after repair without pulmonary stenosis (Doppler gradient more than 30mmHg) OR
• Patients with moderate or severe pulmonary stenosis (Echo Doppler gradient more than 30mmHg)
• Patients without prior Pulmonary Valve Replacement (PVR)
• Written informed Consent obtained
• Aged 13 to 80 years old

You may not qualify if:

• Age less than 13
• Contraindication to MRI Examination
• Cardiac Pacemaker
• Brain Aneurysm OR clips
• Electronic implants OR prosthesis
• Eye metal foreign body injury
• Severe claustrophobia
• Known severe impairment, glomerular filtration rate GFR less than 30 ml/min/BSA
• Non Cardiac illness with life expectancy of less than 2 years
• Previous heart kidney liver or lung transplantation Pregnancy

Sponsors & Collaborators

• National Heart Centre Singapore: lead

Study Sites (1)

National Heart Centre Singapore

Singapore, Singapore, 169609, Singapore

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Ru San Tan, MBBS

  National Heart Centre Singapore

  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: May 31, 2016
• First Posted: June 6, 2016
• Study Start: January 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)