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Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease

Study acronym: THINK
StatusRecruiting
PhasePhase 3
Started2023-03-28
View on ClinicalTrials.gov ↗

Amendment history

2026-07-31
minor
Study Status, IPDSharing v3
Re-verified, no change to tracked fields
2025-11-27
minor
Study Status, Eligibility, Contacts/Locations v2
Primary completion date2027-03→2029-03
Completion date2027-03→2029-03
Study sites36→40
Eligibility criteria+205 characters
Inclusion Criteria: Male or female >=18 years andwith <a clinical frailty score ≤5 for patient aged over 80 years of age Advanced or moderate chronic kidney disease (eGFR 15 to 44. [...] . 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 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 Participant covered by or entitled to social security Writt [...] ine hormone-releasing system) Clinical [...]
2023-10-25
notable
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-03→confirmed 2023-03-28
Study sites1→36
Secondary endpoints10 entries, revised
Change from baseline in proteinuria (g/d) or proteinuria /creatininuriacreatinuria (g/g)
2023-02-08
minor
Original filing
Chronic kidney disease (CKD) is a major public health issue worldwide. Hypertension is the first risk factor in patients with CKD for mortality, cardiovascular disease and end-stage renal disease. It's now well established that lowering blood pressure (BP) reduces renal and cardiovascular complications in this high-risk population. In the general population, in addition to lifestyle interventions, the strategy to initiate and escalate a BP-lowering drug treatment is well described. The drug therapies recommended to achieve optimal BP control in the general population are the following: blockers of the renin-angiotensin system (angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB)), diuretics (thiazides and thiazide-like diuretics), and calcium channel blockers. For patients with CKD, the guidelines advise to start the BP-lowering agent with ACEi or ARB, but then, there is no strong evidence to support the preferential use of any particular agent in controlling BP and the results of clinical trials are discordant. In the NephroTest cohort, a French cohort of patients with CKD stage 1 to 5, among 2015 patients, 1782 had hypertension, only 54% had a diuretic and 44% had uncontrolled hypertension. In this cohort, extracellular fluid (ECF) overload was an independent determinant of hypertension, uncontrolled hypertension and apparent treatment resistant hypertension. In the same cohort, ECF overload was independently associated with end-stage kidney disease and death. Our hypothesis is that patients with CKD and uncontrolled hypertension are fluid overloaded and that the second line of treatment after an ACEi or an ARB should be a diuretic. We hypothesize that a specific algorithm to lower BP in patients with moderate to severe CKD based on diuretics will be more effective in term of cardiovascular event, mortality and evolution to end-stage kidney disease as compared to standard of care.
Trial Details
NCT Number NCT05732727
Lead Sponsor University Hospital, Tours
Conditions Chronic Kidney Disease(CKD), Uncontrolled Hypertension
Enrollment 720 participants
Start Date 2023-03-28
Primary Completion 2029-03 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-03