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Study on Blood Pressure Management with Amiloride Hydrochloride, Indapamide, and Furosemide for Patients with Uncontrolled Hypertension and Chronic Kidney Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for people with uncontrolled hypertension (high blood pressure) who also have moderate to severe chronic kidney disease. The study will explore the effectiveness of different medications, specifically a group of drugs known as diuretics, which help the body get rid of excess salt and water. The medications being tested include Amiloride Hydrochloride, Indapamide, Furosemide, and Hydrochlorothiazide. These medications are commonly used to help lower blood pressure and manage fluid levels in the body.

The purpose of the study is to see if using these diuretics can help reduce the risk of worsening kidney disease, heart problems, and other serious health issues in people with both high blood pressure and chronic kidney disease. Participants in the study will be randomly assigned to receive either the diuretic treatment or the usual management for their condition. The study will last for up to 36 months, during which time participants will have regular check-ups to monitor their health and the effects of the treatment.

Throughout the study, researchers will track various health outcomes, such as the progression of kidney disease, the occurrence of heart-related events like heart attacks or strokes, and overall survival rates. The study aims to provide valuable information on whether intensifying blood pressure treatment with diuretics can offer better health outcomes for patients with these conditions. Participants will also be monitored for any side effects or safety concerns related to the medications used in the trial.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be asked to provide written informed consent. This means you agree to participate after understanding the trial's purpose and procedures.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes checking your age, social security status, and medical history related to chronic kidney disease and hypertension.

  3. Step 3

    Medication administration

    You will be assigned to a treatment group. If you are in the group receiving diuretics, you may be given medications such as amiloride hydrochloride, indapamide, furosemide, or hydrochlorothiazide. These medications are taken orally.

    The dosage and frequency will be determined by the study team based on your specific needs and health status.

  4. Step 4

    Regular monitoring

    Your blood pressure will be monitored regularly at home and during office visits. This helps track the effectiveness of the treatment.

    You will also undergo tests to measure kidney function and other health indicators at months 3 and 6, and then every 6 months.

  5. Step 5

    Quality of life assessment

    Each year, you will complete a survey called PROMIS-29 to assess your quality of life. This helps understand how the treatment affects your daily living.

  6. Step 6

    Safety monitoring

    Throughout the trial, you will be monitored for any side effects or health issues, such as changes in blood volume, electrolyte levels, or kidney function.

  7. Step 7

    End of trial

    The trial is expected to end by January 1, 2027. At the end of the trial, a final assessment will be conducted to evaluate the overall impact of the treatment on your health.

Who can join the trial?

6 criteria

  • Must be a male or female aged 18 years or older and younger than 80 years.
  • Must be covered by or entitled to social security.
  • Must provide written informed consent, which means agreeing to participate after understanding the study details.
  • Must have advanced or moderate chronic kidney disease, which is a long-term condition affecting the kidneys. This is measured by a test called eGFR, which should be between 15.0 to 44.9 ml/min/1.73m².
  • Must have arterial hypertension (high blood pressure) that is being treated with at least one medication that lowers blood pressure. This medication should be a type that affects the renin-angiotensin system, like ACE inhibitors (ACEi) or angiotensin receptor blockers (ARB), at the highest dose the patient can handle. The treatment should be stable for at least one month. Other blood pressure medications can be used if needed.
  • Must have uncontrolled blood pressure when measured in a doctor's office (higher than 140/90 mmHg) and confirmed by home blood pressure monitoring (higher than 135/85 mmHg) or daytime ambulatory blood pressure monitoring.

Who cannot join the trial?

5 criteria

  • Patients with **uncontrolled hypertension** (high blood pressure that is not managed well) cannot participate.
  • Patients with **moderate to severe chronic kidney disease** (a condition where the kidneys are damaged and cannot filter blood as well as they should) are excluded if their hypertension is not controlled.
  • Patients who are at risk of developing **end-stage kidney disease** (the final stage of chronic kidney disease where the kidneys no longer function properly) are not eligible.
  • Patients who are likely to experience **cardiovascular events** (such as heart attacks or strokes) are excluded.
  • Patients with a high risk of **mortality** (risk of death) due to their condition cannot participate.
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Investigated drugs

Diuretics are medications that help your body get rid of extra salt and water by making you urinate more. They are often used to treat high blood pressure and can help reduce the strain on your heart and kidneys. In this trial, diuretics are being used to see if they can help lower blood pressure in patients with chronic kidney disease and prevent further kidney damage or heart problems.

What is already known about the treatment

Diuretics – Diuretics are medications typically taken orally in pill form, designed to help the body eliminate excess salt and water through urine. They are currently well-established in medical practice and literature, particularly for managing high blood pressure and fluid retention. In this clinical trial, diuretics are being evaluated for their effectiveness in treating uncontrolled hypertension in patients with moderate to severe chronic kidney disease. They work by acting on the kidneys to increase urine production, which helps lower blood pressure and reduce the strain on the heart and kidneys. Diuretics are classified as antihypertensive agents due to their role in managing high blood pressure.

Investigated diseases

Uncontrolled Hypertension in Chronic Kidney Disease – Uncontrolled hypertension in chronic kidney disease is a condition where blood pressure remains high despite treatment in individuals with kidney damage. This condition can lead to further kidney damage, as high blood pressure puts additional strain on the kidneys. Over time, the kidneys may lose their ability to filter waste from the blood effectively. As the disease progresses, patients may experience symptoms such as swelling, fatigue, and difficulty concentrating. The progression of kidney damage can eventually lead to end-stage kidney disease, where the kidneys can no longer function adequately. This condition requires careful management to prevent further complications and preserve kidney function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501494-39-00Protocol codeDR210320Estimated enrolment720 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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