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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
Sponsor: University Hospital, Tours
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
720
Start Date
2023-03-28
Completion Date
2029-03
Last Updated
2025-12-01
Healthy Volunteers
No
Interventions
Antihypertensive algorithm
Antihypertensive algorithm based on diuretics agents
Standard of care
standard of care management for antihypertensive therapy intensification
Locations (40)
Department of Nephrology, University Hospital of Angers
Angers, France
Department of Nephrology, University Hospital of Bordeaux
Bordeaux, France
AUB Santé foundation, Brest
Brest, France
Department of Nephrology, University Hospital of Brest
Brest, France
Department of Nephrology, Hospital of Chalon-sur-Saône
Chalon-sur-Saône, France
Department of Nephrology, Hospital of Chartres
Chartres, France
Department of Nephrology, University Hospital of Clermont-Ferrand
Clermont-Ferrand, France
Department of Nephrology, Hospital of Colmar
Colmar, France
Department of Nephrology, University Hospital of Grenoble
Grenoble, France
Department of Nephrology, Hospital of Haguenau
Haguenau, France
Department of Nephrology, Departemental Hospital of Vendée
La Roche-sur-Yon, France
ECHO Santé Association, Le Mans
Le Mans, France
Department of Nephrology, Hospital of Le Puy en Velay
Le Puy-en-Velay, France
Department of Nephrology, University Hospital of Lille
Lille, France
Department of Nephrology, University Hospital of Limoges
Limoges, France
AUB Santé foundation, Lorient
Lorient, France
Department of Nephrology, University Hospital of Lyon
Lyon, France
Department of Nephrology, University Hospital of Marseille
Marseille, France
Department of Nephrology, Regional Hospital of Metz
Metz, France
Department of Nephrology, Régional Hospital of Mulhouse
Mulhouse, France
Department of Nephrology, University Hospital of Nantes
Nantes, France
ECHO Santé Association, Nantes
Nantes, France
Department of Nephrology, University Hospital of Nîmes
Nîmes, France
Department of Nephrology, Hospital of Orléans
Orléans, France
Department of Nephrology, European Hospital Georges Pompidou, AP-HP
Paris, France
Department of Nephrology, Necker Hospital, AP-HP
Paris, France
Department of Nephrology, Bichat Hospital, AP-HP
Paris, France
Department of Nephrology, Tenon Hospital, AP-HP
Paris, France
Department of Nephrology, Hospital of Perpignan
Perpignan, France
Department of Nephrology, University Hospital of Reims
Reims, France
Department of Nephrology, University Hospital of Rennes
Rennes, France
Department of Nephrology, Hospital of Roubaix
Roubaix, France
Department of Nephrology, University Hospital of Rouen
Rouen, France
Department of Nephrology, University Hospital of Saint Etienne
Saint-Etienne, France
ECHO Santé Association, Saint Herblain
Saint-Herblain, France
Department of Nephrology, Hospital of Saint Malo
St-Malo, France
Department of Nephrology, Hospital of Strasbourg
Strasbourg, France
Department of Nephrology, University Hospital of Tours
Tours, France
Department of Nephrology, Hospital of Valenciennes
Valenciennes, France
Department of Nephrology, University Hospital of Nancy
Vandœuvre-lès-Nancy, France