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)
| ISRCTN | ISRCTN97515585 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97515585 |
| Secondary identifying numbers | BHF Project Grant PG/02/027 |
- Submission date
- 06/07/2005
- Registration date
- 08/08/2005
- Last edited
- 05/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael A. Gatzoulis
Scientific
Scientific
Adult Congenital Heart Unit
Royal Brompton Hospital
Sydney Street
London
SW3 6NP
United Kingdom
| Phone | +44 (0)20 7351 8602 |
|---|---|
| m.gatzoulis@rbh.nthames.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | APPROPRIATE |
| Study objectives | Angiotensin-Converting Enzyme (ACE) inhibitor therapy reduces the degree of pulmonary regurgitation and improves right ventricular function, exercise capacity and baroreceptor sensitivity in patients with repaired Tetralogy of Fallot and pulmonary regurgitation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Repaired Tetralogy of Fallot |
| Intervention | 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, then 5 mg for two weeks then 10 mg for rest of study). All patients have two safety blood tests on the basis that they may be on ramipril. There is a protocol of openly changing to losartan in the circumstance of intractable cough. The trial is double blinded and all investigators remain blind as the study is ongoing. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ramipril |
| Primary outcome measure | Improvement in right ventricular function |
| Secondary outcome measures | 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 |
| Overall study start date | 01/10/2002 |
| Completion date | 14/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 25-30 in each arm |
| Key inclusion criteria | All patients with repaired Tetralogy of Fallot and moderate or more pulmonary regurgitant fraction. |
| Key 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 patients 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 |
| Date of first enrolment | 01/10/2002 |
| Date of final enrolment | 14/07/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Adult Congenital Heart Unit
London
SW3 6NP
United Kingdom
SW3 6NP
United Kingdom
Sponsor information
British Heart Foundation (UK)
Charity
Charity
14 Fitzhardinge Street
London
W1H 6DH
United Kingdom
| Phone | +44 (0)20 7935 0185 |
|---|---|
| research@bhf.org.uk | |
| Website | http://www.bhf.org.uk |
"ROR" |
https://ror.org/02wdwnk04 |
Funders
Funder type
Charity
British Heart Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Project Grant PG/02/027
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/02/2012 | Yes | No |
