Effect of Ivabradine use on exercise capacity in patients with transposition of the great arteries (TGA) post atrial switch repair

Phase 2

Recruiting

• Conditions: Transposition of great arteries; Congenital heart disease; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12621000196842
• Lead Sponsor: Melbourne Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-24
• Last Update Posted: 28 February 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Age > 18
Transposition of great arteries with previous atrial switch repair

Exclusion Criteria

1.Congestive heart failure
2.Unable to exercise
3.Not in sinus rhythm (atrial flutter/fibrillation)
4.Bradycardia or resting heart rate below 60bpm
5.Severe hepatic impairment
6.Combination with strong cytochrome P450 inhibitors (eg. Ketoconazole, macrolide antibiotics, HIV protease inhibitors, nefazodone) or with QT prolonging medications
7.Pregnancy, lactation
8.Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption (lactose excipient in tablet)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exercise capacity using a cardiopulmonary stress test (VO2 max), which will be performed on a stationary upright bicycle.[4 and 8 weeks; 4 weeks post commencement of intervention (ivabradine or placebo). Repeat test at 8 weeks (4 weeks after crossover) ]