FAN Trial: A randomised controlled open label trial assessing the effect of perindopril erbumine on Fontan-Associated Nephropathy
FAN Trial: A randomised controlled open label trial assessing the effect of perindopril erbumine on Fontan-Associated Nephropathy in adults and children 5 years or older.
Australian Heart Foundation
50 participants
Jun 1, 2024
Interventional
Conditions
Summary
To evaluate in patients with a Fontan circulation with evidence of nephropathy whether initiation of perindopril erbumine reduces the degree of microalbuminuria compared to controls as measured by a spot urine albumin-creatinine ratio over 6 months of treatment.
Eligibility
Inclusion Criteria5
- Are a minimum 5 years of age at the time of screening AND are a minimum of 12-months post Fontan completion (no maximum age)
- Live within Auckland or within 2-3 hour drive of Auckland, NZ or in New South Wales, Australia and can attend multiple study visits at the closest respective centre.
- Are not currently taking an ACE inhibitor or ARB, nor have taken a medication belonging to either of these two classes for greater than 7 consecutive days within the last 3 months prior to screening urine sample.
- Evidence of established nephropathy defined as an elevated urine albumin-creatinine ratio (>2.5mg/mmol in males and >3.5mg/mmol in females) and/or GFR 30-90 ml/min/1.73m2
- Are up-to-date with vaccinations based on the countrywide, accepted schedule of childhood vaccines, including Covid-19 prevention
Exclusion Criteria15
- Currently pregnant or have been pregnant within the past 12 months beyond the first trimester (13 weeks), (identified at initial phone call).
- Of child-bearing potential with ineffective contraception.
- Currently breastfeeding.
- Known hypersensitivity or intolerance to ACE inhibitors
- Currently on lithium or requiring high doses of diuretics
- eGFR or GFR <30 ml/min/1.73m2 (pre-existing, or identified at baseline)
- Known bilateral renal artery stenosis
- Known uncontrolled hypertension
- Moderate or greater systemic ventricular dysfunction on most recent echocardiogram
- Baseline hyperkalaemia (K > 5.5mmol/L in a non-haemolysed sample)
- Current treatments with regular non-steroidal anti-inflammatory drugs (NSAIDs) (excluding low dose aspirin which is standard of care in many Fontan patients)
- Diagnosis of diabetes mellitus
- Concurrent use of another experimental drug
- Participants who currently require surgical intervention or are anticipated to require surgical intervention relating to their Fontan circulation during the time period of the study.
- Children unable to swallow tablets
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Interventions
This is a prospective, multi-centre, randomised-controlled trial of perindopril erbumine versus non-intervention in children and adults with a Fontan circulation and evidence of established nephropathy defined as an elevated urine albumin-creatinine ratio (>2.5mg/mmol in males and >3.5mg/mmol in females), and/or a reduced GFR (<90ml/min/1.73m2). Eligible participants will be randomised to receive either perindopril erbumine or no intervention, with stratification based on sex and age (<18 or >=18). Dosage and route of administration Group A will receive the ACE inhibitor perindopril erbumine taken orally at the following doses: <25kg– oral tablet 1mg once daily, titrated to a maximum dose of 2mg once daily =/>25kg – oral tablet 2mg once daily titrated to a maximum dose of 4mg once daily Dose tolerance will be checked at visit 2 (2 weeks) and up-titrated only if study investigators are confident that the participant is not experiencing any significant adverse effects. Participants will not be titrating the dose themselves. Titration for those <25kg will be as follows: commence on 1mg once daily, then increase as tolerated to 2mg at the 2-week visit. Titration for those =25kg will be as follows: commence on 2mg once daily, then increase as tolerated to 4mg at the 2-week visit. Participants will then continue on the maximum tolerated dose for a total of 26 weeks, i.e., from week 2 to week 28 post-randomisation. Participants who do not tolerate a total daily dose of 2mg or greater (1mg in those <25 kg) will be excluded from the study.
Locations(1)
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ACTRN12624000648527