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
Location: See all (36) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Male or female \>=18 years and \<80 years of age

• Advanced or moderate chronic kidney disease (eGFR 15 to 44.9 mL/min/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.

• Uncontrolled office BP (\>140 and/or 90 mmHg) confirmed by home blood pressure monitoring (\>135/85 mmHg)

• Participant covered by or entitled to social security

• Written informed consent obtained from the participant

Locations
Other Locations
France
Department of Nephrology, University Hospital of Angers
RECRUITING
Angers
Department of Nephrology, University Hospital of Bordeaux
ACTIVE_NOT_RECRUITING
Bordeaux
AUB Santé foundation, Brest
ACTIVE_NOT_RECRUITING
Brest
Department of Nephrology, University Hospital of Brest
RECRUITING
Brest
Department of Nephrology, Hospital of Chalon-sur-Saône
RECRUITING
Chalon-sur-saône
Department of Nephrology, Hospital of Chartres
RECRUITING
Chartres
Department of Nephrology, University Hospital of Clermont-Ferrand
RECRUITING
Clermont-ferrand
Department of Nephrology, Hospital of Colmar
RECRUITING
Colmar
Department of Nephrology, University Hospital of Grenoble
ACTIVE_NOT_RECRUITING
Grenoble
Department of Nephrology, Hospital of Haguenau
ACTIVE_NOT_RECRUITING
Haguenau
Department of Nephrology, Departemental Hospital of Vendée
RECRUITING
La Roche-sur-yon
ECHO Santé Association, Le Mans
ACTIVE_NOT_RECRUITING
Le Mans
Department of Nephrology, Hospital of Le Puy en Velay
RECRUITING
Le Puy-en-velay
Department of Nephrology, University Hospital of Limoges
RECRUITING
Limoges
Department of Nephrology, University Hospital of Lyon
ACTIVE_NOT_RECRUITING
Lyon
Department of Nephrology, University Hospital of Marseille
ACTIVE_NOT_RECRUITING
Marseille
Department of Nephrology, Regional Hospital of Metz
RECRUITING
Metz
Department of Nephrology, Régional Hospital of Mulhouse
RECRUITING
Mulhouse
Department of Nephrology, University Hospital of Nantes
RECRUITING
Nantes
ECHO Santé Association, Nantes
ACTIVE_NOT_RECRUITING
Nantes
Department of Nephrology, University Hospital of Nîmes
ACTIVE_NOT_RECRUITING
Nîmes
Department of Nephrology, Bichat Hospital, AP-HP
ACTIVE_NOT_RECRUITING
Paris
Department of Nephrology, European Hospital Georges Pompidou, AP-HP
ACTIVE_NOT_RECRUITING
Paris
Department of Nephrology, Necker Hospital, AP-HP
ACTIVE_NOT_RECRUITING
Paris
Department of Nephrology, Tenon Hospital, AP-HP
ACTIVE_NOT_RECRUITING
Paris
Department of Nephrology, Hospital of Perpignan
ACTIVE_NOT_RECRUITING
Perpignan
Department of Nephrology, University Hospital of Reims
ACTIVE_NOT_RECRUITING
Reims
Department of Nephrology, University Hospital of Rennes
ACTIVE_NOT_RECRUITING
Rennes
Department of Nephrology, Hospital of Roubaix
RECRUITING
Roubaix
Department of Nephrology, University Hospital of Rouen
ACTIVE_NOT_RECRUITING
Rouen
Department of Nephrology, University Hospital of Saint Etienne
RECRUITING
Saint-etienne
ECHO Santé Association, Saint Herblain
ACTIVE_NOT_RECRUITING
Saint-herblain
Department of Nephrology, Hospital of Saint Malo
ACTIVE_NOT_RECRUITING
St-malo
Department of Nephrology, University Hospital of Tours
RECRUITING
Tours
Department of Nephrology, Hospital of Valenciennes
RECRUITING
Valenciennes
Department of Nephrology, University Hospital of Nancy
ACTIVE_NOT_RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Bénédicte Sautenet, MD
benedicte.sautenet@gmail.com
02.34.37.96.86
Time Frame
Start Date: 2023-03-28
Estimated Completion Date: 2027-03
Participants
Target number of participants: 720
Treatments
Experimental: Experimental group
Antihypertensive algorithm based on diuretics agents : the clinicians will adjust the drug therapy according to the antihypertensive algorithm based on diuretics agents.
Active_comparator: Control group
Standard of care : the clinicians will adapt the antihypertensive strategy according to his own standard of care which can be pharmacological or non-pharmacological therapies.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Tours

This content was sourced from clinicaltrials.gov