Condition category
Circulatory System
Date applied
06/07/2005
Date assigned
08/08/2005
Last edited
05/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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 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

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

http://www.bhf.org.uk

Funders

Funder type

Charity

Funder name

British Heart Foundation

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20970202

Publication citations

  1. 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.

Additional files

Editorial Notes