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

Uncontrolled Hypertension Clinical Trial

Official title:
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 Label, a Cluster Randomized Controlled, Phase 3 Trial

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05732727
Study type	Interventional
Source	University Hospital, Tours
Contact	Bénédicte Sautenet, MD
Phone	02.34.37.96.86
Email	benedicte.sautenet@gmail.com
Status	Recruiting
Phase	Phase 3
Start date	March 28, 2023
Completion date	March 2027

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT01939392` - Rapid Renal Sympathetic Denervation for Resistant Hypertension II	Phase 2/Phase 3
Terminated	`NCT01966952` - Evaluation of Safety Mechanisms of Renal Radioablation(RSRA)for Uncontrolled Hypertension	N/A
Completed	`NCT01699529` - Multi-electrode Radiofrequency Renal Denervation System Feasibility Study	N/A
Completed	`NCT01418261` - SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension	N/A
Completed	`NCT01635998` - Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation	N/A
Completed	`NCT02674464` - Reducing Inequities in Care of Hypertension, Lifestyle Improvement for Everyone (RICH LIFE Project)	N/A
Completed	`NCT04809519` - Integrative Nursing Based Multimodal Interventions for Uncontrolled Hypertensives	N/A
Completed	`NCT01996033` - EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension
Terminated	`NCT01628198` - Impact of Renal SympAthetic DenerVation on Chronic HypErtension	N/A
Recruiting	`NCT03221114` - Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease	N/A
Completed	`NCT04248530` - DENEX Renal Denervation in Patients With Uncontrolled Hypertension: Safety Study	N/A
Recruiting	`NCT06034743` - A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension	Phase 3
Completed	`NCT02006758` - Observational Study of the EnligHTN Renal Denervation System in Europe
Active, not recruiting	`NCT03209154` - An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment	N/A
Withdrawn	`NCT05352425` - Effect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension	N/A
Completed	`NCT05395403` - Use of Automated Office Blood Pressure Monitoring	N/A
Completed	`NCT02418091` - Integrated Population Program for Diabetic Kidney Disease	N/A
Not yet recruiting	`NCT05234788` - Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN	N/A
Completed	`NCT00888433` - Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)	N/A
Recruiting	`NCT05460169` - Renal Denervation in ADPKD- RDN-ADPKD Study	N/A