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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN97515585

Enrollment

Registered

2005-08-08

Start date

2002-10-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Repaired Tetralogy of Fallot Circulatory System Tetralogy of Fallot

Interventions

Ramipril 10 mg once daily for six months compared to placebo (blister packaged capsules indistinguishable from the blister packaged active drug and also taken in increasing dose ? 2.5 mg for one week,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients with repaired Tetralogy of Fallot and moderate or more pulmonary regurgitant fraction.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Improvement in right ventricular function	—

Secondary

Measure	Time frame
1. Reduction in pulmonary regurgitant fraction 2. Reduction of right ventricular volume 3. Reduction of right ventricular mass 4. Reduction of left ventricular volume 5. Improvement of left ventricular systolic function 6. Improvement of exercise performance 7. Improvement in baroreceptor sensitivity and heart rate variability	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026