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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

NCT ID: NCT05732727

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-28

Study Completion Date

2029-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease(CKD) Uncontrolled Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The very nature of the intervention assessed prevents any form of blinding, neither for care providers, nor for patients.

However, the primary outcome is a composite outcome of events which we plan to adjudicate. As a consequence, the primary outcome will be blindly assessed.

Study Groups

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Experimental group

Antihypertensive algorithm based on diuretics agents : the clinicians will adjust the drug therapy according to the antihypertensive algorithm based on diuretics agents.

Group Type EXPERIMENTAL

Antihypertensive algorithm

Intervention Type DRUG

Antihypertensive algorithm based on diuretics agents

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.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type DRUG

standard of care management for antihypertensive therapy intensification

Interventions

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Antihypertensive algorithm

Antihypertensive algorithm based on diuretics agents

Intervention Type DRUG

Standard of care

standard of care management for antihypertensive therapy intensification

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female \>=18 years with a clinical frailty score ≤5 for patient aged over 80
* 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 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
* Written informed consent obtained from the participant

Exclusion Criteria

* Patient following any measures of legal presentation
* Pregnant or breastfeeding woman
* 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)
* Clinical signs of hypovolemia
* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bénédicte Sautenet, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

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Department of Nephrology, University Hospital of Angers

Angers, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Bordeaux

Bordeaux, , France

Site Status RECRUITING

AUB Santé foundation, Brest

Brest, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Brest

Brest, , France

Site Status RECRUITING

Department of Nephrology, Hospital of Chalon-sur-Saône

Chalon-sur-Saône, , France

Site Status RECRUITING

Department of Nephrology, Hospital of Chartres

Chartres, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Department of Nephrology, Hospital of Colmar

Colmar, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Grenoble

Grenoble, , France

Site Status RECRUITING

Department of Nephrology, Hospital of Haguenau

Haguenau, , France

Site Status RECRUITING

Department of Nephrology, Departemental Hospital of Vendée

La Roche-sur-Yon, , France

Site Status RECRUITING

ECHO Santé Association, Le Mans

Le Mans, , France

Site Status RECRUITING

Department of Nephrology, Hospital of Le Puy en Velay

Le Puy-en-Velay, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Lille

Lille, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Limoges

Limoges, , France

Site Status RECRUITING

AUB Santé foundation, Lorient

Lorient, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Lyon

Lyon, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Marseille

Marseille, , France

Site Status RECRUITING

Department of Nephrology, Regional Hospital of Metz

Metz, , France

Site Status RECRUITING

Department of Nephrology, Régional Hospital of Mulhouse

Mulhouse, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Nantes

Nantes, , France

Site Status RECRUITING

ECHO Santé Association, Nantes

Nantes, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Nîmes

Nîmes, , France

Site Status RECRUITING

Department of Nephrology, Hospital of Orléans

Orléans, , France

Site Status RECRUITING

Department of Nephrology, European Hospital Georges Pompidou, AP-HP

Paris, , France

Site Status ACTIVE_NOT_RECRUITING

Department of Nephrology, Necker Hospital, AP-HP

Paris, , France

Site Status RECRUITING

Department of Nephrology, Bichat Hospital, AP-HP

Paris, , France

Site Status RECRUITING

Department of Nephrology, Tenon Hospital, AP-HP

Paris, , France

Site Status ACTIVE_NOT_RECRUITING

Department of Nephrology, Hospital of Perpignan

Perpignan, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Reims

Reims, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Rennes

Rennes, , France

Site Status RECRUITING

Department of Nephrology, Hospital of Roubaix

Roubaix, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Rouen

Rouen, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Saint Etienne

Saint-Etienne, , France

Site Status RECRUITING

ECHO Santé Association, Saint Herblain

Saint-Herblain, , France

Site Status ACTIVE_NOT_RECRUITING

Department of Nephrology, Hospital of Saint Malo

St-Malo, , France

Site Status RECRUITING

Department of Nephrology, Hospital of Strasbourg

Strasbourg, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Tours

Tours, , France

Site Status RECRUITING

Department of Nephrology, Hospital of Valenciennes

Valenciennes, , France

Site Status RECRUITING

Department of Nephrology, University Hospital of Nancy

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Bénédicte Sautenet, MD

Role: CONTACT

[email protected]
02.34.37.96.86 ext. +33

Facility Contacts

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Martin PLANCHAIS, MD

Role: primary

Pierre PFIRMANN, MD-PhD

Role: primary

Morgane GOSSELIN, MD

Role: primary

Yannick LE MEUR, MD-PhD

Role: primary

Magali LOUIS, MD

Role: primary

Nestor NANKEU, MD

Role: primary

Julien ANIORT, MD

Role: primary

Alexandre KLEIN, MD

Role: primary

Pierre Louis CARRON, MD

Role: primary

Julien OTT, MD

Role: primary

Anne Hélène QUERARD, MD

Role: primary

Louis Marie VERNIER, MD

Role: primary

Marc BOUILLER, MD

Role: primary

Marie FRIMAT, Md-PhD

Role: primary

Fatouma TOURE, MD-PhD

Role: primary

Gabrielle DUNEAU, MD

Role: primary

Jean Pierre FAUVEL, MD-PhD

Role: primary

Stéphane BURTEY, MD-PhD

Role: primary

Thomas QUINAUX, MD

Role: primary

François CHANTREL, MD

Role: primary

Caroline GOURRAUD VERCEL, MD

Role: primary

Lila GHOUTI TERKI, MD

Role: primary

Olivier MORANNE, MD-PhD

Role: primary

Marion DEKEYSER, MD

Role: primary

Dominique JOLY, MD-PhD

Role: primary

François VRTOVSNIK, MD-PhD

Role: primary

Sébastien CANET, MD

Role: primary

Pierre Guillaume DELIEGE, MD

Role: primary

Thierry FROUGET, MD

Role: primary

Thomas GUINCESTRE, MD

Role: primary

Dominique GUERROT, MD-PHD

Role: primary

Christophe MARIAT, MD-PhD

Role: primary

Eric RENAUDINEAU, MD

Role: primary

Nans FLORENS, MD-PhD

Role: primary

Bénédicte SAUTENET, MD

Role: primary

Marc ULRICH, MD

Role: primary

Adrien FLAHAULT, MD-PhD

Role: primary

Other Identifiers

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2022-501494-39-00

Identifier Type: OTHER

Identifier Source: secondary_id

DR210320

Identifier Type: -

Identifier Source: org_study_id

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