NCT05228574CompletedPhase 4
Trampoline study
Treatment of vascular stiffness in patients with autosomal dominant polycystic kidney disease
Source: EU CTIS (euclinicaltrials.eu) · Last updated 24 May 2024
Brief summary (registry, in English)
We aim to determine if arterial stiffness is exacerbated due to a high-salt diet in patients with ADPKD and whether treatment with amiloride prevents these effects. We divided the main objective into three sub-objectives: 1. To determine if arterial stiffness is exacerbated due to a high-salt diet in patients with ADPKD. 2. To investigate whether amiloride treatment could reduce the effect of high salt on arterial stiffness in the group with salt supplement. 3. To investigate whether treatment with amiloride further reduces arterial stiffness in the setting of a low-salt diet.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 54 (actual)
- First submitted
- 30 Apr 2024
- Start date
- 5 May 2022
- Lead sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- NCT number
- NCT05228574
- EU CT number
- 2024-512544-27-00
- EudraCT number
- 2020-000433-40
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 54
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant use of drugs that could influence blood pressure and/or disease progression (Tolvaptan/non-steroidal anti-inflammatory drugs (NSAIDs)/chemotherapy), excluding £ 2 antihypertensive drugs
- Concomitant use of ≥ 3 antihypertensive medications
- Immunosuppressive therapy within the last year
Other illness
- Uncontrolled hypertension, defined as an office blood pressure of ≥160/ ≥90 mmHg with or without antihypertensive treatment
- When antihypertensive treatment is prescribed for any other treatment indication than hypertension (e.g. cardia arrhythmia)
- History of liver disease (excluding liver cysts due to ADPKD)
- History of diabetes mellitus
- Active infection or antibiotic therapy
Lab values
- Serum potassium levels >5.5 mmol/L (measured within last 6 months)
- History of heart failure (cardiac ejection fraction < 35%) or cardiac arrhythmia
Other
- Actual pregnancy or unwillingness to adhere to reproductive precautions during the duration of the study
Who the study is looking for
- Adults with typical ADPKD diagnosed 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.