A randomised controlled trial of the effect of angiotensin-converting enzyme inhibitors on pulmonary regurgitation, biventricular volume, mass and function, integrated cardiopulmonary exercise and cardiac autonomic reflexes late after Tetralogy of Fallot repair. The APPROPRIATE study (Ace inhibitors for PRevention Of Pulmonary Regurgitation In Adults with TEtralogy)
Completed
- Conditions
- Repaired Tetralogy of FallotCirculatory SystemTetralogy of Fallot
- Registration Number
- ISRCTN97515585
- Lead Sponsor
- British Heart Foundation (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
All patients with repaired Tetralogy of Fallot and moderate or more pulmonary regurgitant fraction.
Exclusion Criteria
1. Known allergy or hypersensitivity to ACE-inhibitors
2. History of coronary artery disease
3. Pulmonary stenosis more than mild
4. Unable to undertake Cardiovascular Magnetic Resonance (permanent pacemaker, electrical device etc.)
5. Renal failure, assessed from patient?s clinical notes and baseline biochemistry check.
6. Ongoing ACE-inhibitor therapy
7. Pregnancy/breastfeeding/planning to conceive during participation
8. Systolic blood pressure less than 90 mmHg
9. Hyperkaliemia (K+ levels more than 5.5 mEq/l)
10. Refusal to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method