Treatment of Vascular Stiffness in ADPKD (TRAMPOLINE)
Autosomal Dominant Polycystic Kidney
About this trial
This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney focused on measuring Polycystic kidney disease, Amiloride, Salt, Hypertension
Eligibility Criteria
Inclusion Criteria:
- Adults with typical ADPKD diagnosed based on Ravine criteria and/or a documented Pkd 1 or 2 mutation
- Chronic kidney disease epidemiology collaboration equation estimated glomerular filtration rate ≥60 ml/min/1.73m2
- Ability to provide informed consent
Exclusion Criteria:
- Uncontrolled hypertension, defined as an office blood pressure of ≥160/ ≥90 mmHg with or without antihypertensive treatment
- Concomitant use of ≥ 3 antihypertensive medications
- When antihypertensive treatment is prescribed for any other treatment indication than hypertension (e.g. cardia arrhythmia)
- Serum potassium levels >5.5 mmol/L (measured within last 6 months)
- History of liver disease (excluding liver cysts due to ADPKD)
- History of heart failure (cardiac ejection fraction < 35%) or cardiac arrhythmia
- History of diabetes mellitus
- Active infection or antibiotic therapy
- Immunosuppressive therapy within the last year
- Concomitant use of drugs that could influence blood pressure and/or disease progression (Tolvaptan/non-steroidal anti-inflammatory drugs (NSAIDs)/chemotherapy), excluding < 3 antihypertensive drugs
- Actual pregnancy or unwillingness to adhere to reproductive precautions during the duration of the study
Sites / Locations
- Erasmus University Medical Centre RotterdamRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
High-salt group (group 1)
Low-salt group (group 2)
All participants will be subjected to a low-salt diet (3.5 grams/day) for six weeks. Group 1 will receive sodium chloride capsules (6 grams/day) for four weeks. In the last two weeks of the trial, all participants will be treated with amiloride tablets (20 mg daily) in open-label setting.
All participants will be subjected to a low-salt diet (3.5 grams/day) for six weeks. Group 2 will receive placebo capsules (6 grams/day) for four weeks. In the last two weeks of the trial, all participants will be treated with amiloride tablets (20 mg daily) in open-label setting.