FAN Trial: A randomised controlled open label trial assessing the effect of perindopril erbumine on Fontan-Associated Nephropathy

Phase 4

• Conditions: congenital heart disease; Single Ventricle; Fontan Associated Nephropathy; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12624000648527
• Lead Sponsor: Australian Heart Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-21
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•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 Criteria

•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

Study & Design

• Study Type: Interventional
• Study Design: Not specified