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THINK - intensification of blood pressure lowering Therapeutics based on diuretics versus usual management for uncontrolled Hypertension IN patients with moderate to severe chronic Kidney disease: an open lapel, cluster randomized controlled, phase 3 trial
EU CTIS ID: 2022-501494-39-00
What this study is testing
To assess the efficacy of an algorithm based on diuretic agents in patients with moderate to severe chronic kidney disease and uncontrolled hypertension in reducing the incidence of end-stage kidney disease, chronic kidney disease progression, cardiovascular events and mortality
- Therapeutic confirmatory (Phase III)
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
- Male or female >=18 years with a clinical frailty score ≤5 for patient aged over 80
- Participant covered by or entitled to social security
- Written informed consent obtained from the participant
- Advanced or moderate chronic kidney disease (eGFR 15.0 to 44.9 ml/mn/1.73m² using CKD-Epi formula)
- Arterial hypertension treated with at least one blood pressure lowering drug therapy among blockers of the renin-angiotensin system (ACEi or ARB), at the maximal posology tolerated by the patients, stable since at least one month. Other blood pressure lowering drug therapies are tolerated in combination with or in the event of intolerance to ACE inhibitors or ARBs.
- Uncontrolled office BP (>140 and/or 90 mmHg) confirmed by home blood pressure monitoring (> 135 and/or 85 mmHg) or Day-time Ambulatory Blood Pressure Monitoring.
You likely can't join if
- Patient following any measures of legal presentation
- Symptomatic orthostatic hypotension
- Hyponatremia (<130 mmol/L)
- Dyskalemia (<3,5 mmol/L or >5,5 mmol/L)
- Major adverse cardiovascular event during the last three months: myocardial infarction, heart failure hospitalization, stroke
- Current medical history of cancer requiring chemotherapy
See the full eligibility criteria
- Male or female >=18 years with a clinical frailty score ≤5 for patient aged over 80
- Participant covered by or entitled to social security
- Written informed consent obtained from the participant
- Advanced or moderate chronic kidney disease (eGFR 15.0 to 44.9 ml/mn/1.73m² using CKD-Epi formula)
- Arterial hypertension treated with at least one blood pressure lowering drug therapy among blockers of the renin-angiotensin system (ACEi or ARB), at the maximal posology tolerated by the patients, stable since at least one month. Other blood pressure lowering drug therapies are tolerated in combination with or in the event of intolerance to ACE inhibitors or ARBs.
- Uncontrolled office BP (>140 and/or 90 mmHg) confirmed by home blood pressure monitoring (> 135 and/or 85 mmHg) or Day-time Ambulatory Blood Pressure Monitoring.
- Patient following any measures of legal presentation
- Symptomatic orthostatic hypotension
- Hyponatremia (<130 mmol/L)
- Dyskalemia (<3,5 mmol/L or >5,5 mmol/L)
- Major adverse cardiovascular event during the last three months: myocardial infarction, heart failure hospitalization, stroke
- Current medical history of cancer requiring chemotherapy
- Solid organ transplantation
- woman of childbearing without a highly effective contraceptive measure (combined or progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device or intrauterine hormone-releasing system)
- Two or more diuretic agents (loop diuretic, thiazides and thiazide-like diuretics)
- Mineralocorticoid receptor antagonists
- Autosomal dominant polycystic kidney disease treated with Tolvaptan
- Contraindication to diuretics involved in the algorithm
- Severe heart failure (NYHA III_IV)
- Cirrhosis Child B-C
- Pregnant or breastfeeding woman
- Clinical signs of hypovolemia
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.