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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

RecruitingPhase 3Ages 18 Years - anyAllUniversity Hospital, Tours
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In plain words

What the trial is, and whether it could suit you

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, b

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📋 Eligibility rules (as published)
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
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What it tests

  • Antihypertensive algorithm
  • Standard of care
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Where

40 sites
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

…and 32 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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