Treatment of Vascular Stiffness in ADPKD

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Autosomal dominant polycystic kidney disease (ADPKD) is the most common inherited kidney disease characterized by cystic kidneys and caused by mutations in the polycystic kidney disease and other rare genes. It is associated with salt-sensitive hypertension, which accounts for the majority of morbidity and mortality. About 70% of patients with ADPKD develop hypertension, prior to the onset of kidney function decline. Early onset hypertension, despite its treatment, is independently associated with rapid kidney function decline. The investigators hypothesize that a high-sodium diet in patients with ADPKD is required for the development of vascular stiffness, which precedes hypertension, and that treatment with amiloride reverses this phenomenon.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Treatments: Amiloride

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