BridgeMD
Trampoline study
EU CTIS ID: 2024-512544-27-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Uncontrolled hypertension, defined as an office blood pressure of ≥160/ ≥90 mmHg with or without antihypertensive 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
- Actual pregnancy or unwillingness to adhere to reproductive precautions during the duration of the study
- 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)
See the full eligibility criteria
- 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
- Uncontrolled hypertension, defined as an office blood pressure of ≥160/ ≥90 mmHg with or without antihypertensive 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
- Actual pregnancy or unwillingness to adhere to reproductive precautions during the duration of the study
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.