Contact information
Type
Scientific
Primary contact
Dr Michael A. Gatzoulis
ORCID ID
Contact details
Adult Congenital Heart Unit
Royal Brompton Hospital
Sydney Street
London
SW3 6NP
United Kingdom
+44 (0)20 7351 8602
m.gatzoulis@rbh.nthames.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BHF Project Grant PG/02/027
Study information
Scientific title
Acronym
APPROPRIATE
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/10/2002
Overall trial end date
14/07/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients with repaired Tetralogy of Fallot and moderate or more pulmonary regurgitant fraction.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
25-30 in each arm
Participant 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
Recruitment start date
01/10/2002
Recruitment end date
14/07/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Adult Congenital Heart Unit
London
SW3 6NP
United Kingdom
Sponsor information
Organisation
British Heart Foundation (UK)
Sponsor details
14 Fitzhardinge Street
London
W1H 6DH
United Kingdom
+44 (0)20 7935 0185
research@bhf.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation
Alternative name(s)
BHF
Funding Body Type
unknown
Funding Body Subtype
Location
Funder name
Project Grant PG/02/027
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20970202
Publication citations
-
Results
Babu-Narayan SV, Uebing A, Davlouros PA, Kemp M, Davidson S, Dimopoulos K, Bayne S, Pennell DJ, Gibson DG, Flather M, Kilner PJ, Li W, Gatzoulis MA, Randomised trial of ramipril in repaired tetralogy of Fallot and pulmonary regurgitation: the APPROPRIATE study (Ace inhibitors for Potential PRevention Of the deleterious effects of Pulmonary Regurgitation In Adults with repaired TEtralogy of Fallot)., Int. J. Cardiol., 2012, 154, 3, 299-305, doi: 10.1016/j.ijcard.2010.09.057.