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 study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
CHU Grenoble Alpes La Tronche France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Centre Hospitalier Departemental Vendee La Roche sur Yon France
Centre Hospitalier Universitaire Rouen Rouen France
Hôpital Pontchaillou-CHU Rennes Rennes France
Centre Hospitalier Universitaire De Nantes Nantes France
Hospices Civils De Lyon Lyon France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier De Perpignan Perpignan France
Centre Hospitalier William Morey Chalon Sur Saone France
Centre Hospitalier De Roubaix Roubaix France
EXPANSION CENTRES HEMODIALYSE OUEST Reze France
EXPANSION CENTRES HEMODIALYSE OUEST Saint-Herblain France
Centre Hospital Region Metz Thionville Metz France
Groupe Hospitalier Rance Emeraude Saint-Malo France
Centre Hospitalier Pasteur Colmar France
Centre Hospitalier Universitaire d’Orléans Orléans France
Assistance Publique Hopitaux De Paris Paris France
Assistance Publique Hopitaux De Paris Paris France
Assistance Publique Hopitaux De Paris Paris France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace Mulhouse France
CHU Gabriel-Montpied Clermont Ferrand France
Centre Hospitalier De Haguenau Haguenau France
Les Hopitaux De Chartres Le Coudray France
Centre Hospitalier De Valenciennes Valenciennes France
Centre Hospitalier Du Puy Le Puy-En-Velay France
Aub Sante Saint-Gregoire France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
28.03.2023

Trial locations

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.

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 ID:
2022-501494-39-00
Protocol code:
DR210320
NCT ID:
NCT05732727
Trial Phase:
Therapeutic confirmatory (Phase III)

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