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

Launched by UNIVERSITY HOSPITAL, TOURS · Feb 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to lower blood pressure in patients with chronic kidney disease (CKD) who have uncontrolled hypertension, meaning their blood pressure remains too high despite treatment. The researchers believe that these patients may be retaining too much fluid, which makes it harder to control their blood pressure. They want to see if using diuretics (medications that help remove excess fluid from the body) as a second-line treatment, after starting with standard medications, will be more effective than usual care in reducing the risk of heart problems, death, and the progression to severe kidney disease.

To participate in this trial, individuals must be between 18 and 80 years old with moderate to severe CKD and high blood pressure that isn’t well controlled. They should be taking at least one type of blood pressure medication and still have high readings. Participants will receive close monitoring and treatment adjustments based on their health needs. It’s important to note that certain conditions, such as being pregnant or having severe heart issues, may prevent someone from joining. If you or a loved one meet the criteria and are interested, this trial could provide new insights into managing blood pressure in patients with CKD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• 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
• • 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