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Treatment of vascular stiffness in patients with autosomal dominant polycystic kidney disease

Phase 4
Recruiting
Conditions
Polycystic kidney disease
10038430
Registration Number
NL-OMON55149
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
54
Inclusion Criteria

- Adults with ADPKD diagnosis based on Ravine criteria and/or a documented Pkd
1 or 2 mutation
- CKD-EPI eGFR >=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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The three primary outcomes of this study are a difference in central arterial<br /><br>stiffness, measured as the pulse wave velocity (PWV), in highsalt<br /><br>group versus low-salt group, and before versus after amiloride treatment in<br /><br>both groups.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcomes include ambulatory (24-hour) blood pressures, markers of<br /><br>inflammation, salt tasting test and skin sodium content through 23Na-MRI. </p><br>
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