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Study on the Effectiveness of Ethanol in Treating Hypertension in Patients with Uncontrolled High Blood Pressure

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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 Hypertension, a condition where blood pressure in the arteries is consistently too high. The trial will use a treatment called the Peregrine System™ Kit, which involves a procedure known as renal denervation. This procedure uses a special solution containing ethanol, anhydrous, delivered through a device called the Peregrine System™ Infusion Catheter. The catheter is designed to target nerves near the kidneys that help control blood pressure.

The purpose of the study is to evaluate how effective this treatment is when used alongside regular blood pressure medications. Participants will be randomly assigned to receive either the actual treatment or a placebo procedure. The study will monitor changes in blood pressure over several months to see if the treatment helps lower it more effectively than the placebo.

Participants will continue their usual blood pressure medications throughout the study. The trial will involve several visits over a period of months, during which blood pressure will be measured and any changes in medication will be recorded. The study aims to provide more information on whether this new treatment can help people with high blood pressure manage their condition better.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant must have provided written consent and be between 18 and 80 years old.
The participant should be taking 2-5 medications for high blood pressure and agree to maintain a stable medication regimen during the study.
Step 2
Run-in period
The participant will maintain their current medication regimen for 4 weeks.
Blood pressure will be monitored to ensure it meets the study criteria: systolic blood pressure (SBP) between 150 and 180 mmHg and diastolic blood pressure (DBP) of at least 90 mmHg.
Step 3
Procedure
The procedure involves renal denervation using the Peregrine System™ Kit, which delivers a solution for injection containing anhydrous ethanol to the renal arteries.
This procedure aims to reduce nerve activity in the kidneys, potentially lowering blood pressure.
Step 4
Post-procedure follow-up
The participant will continue their antihypertensive medication regimen for 3 months after the procedure.
Blood pressure will be monitored at various intervals: 3 months, 6 months, and up to 12 months post-procedure.
Step 5
Monitoring and evaluation
The primary goal is to observe changes in 24-hour ambulatory SBP from the start to 3 months after the procedure.
Secondary goals include monitoring changes in office SBP and DBP, as well as any adjustments in medication regimen.
Step 6
Long-term follow-up
The study will continue to monitor participants for up to 3 years to assess long-term effects and any adverse events.
Regular assessments will include blood pressure measurements and kidney function tests.

Who can join the trial?

9 criteria

The person must have given written permission to join the study.
The person must be a man or woman between 18 and 80 years old.
The person must be taking 2 to 5 medications for high blood pressure and agree to keep the same medication routine for a certain period before and after the procedure. Two of these medications should be at least half of the maximum dose. If taking only 2 medications, one should be an ACE inhibitor or ARB, unless the person cannot tolerate them. The person must also be taking or have tried a diuretic, which helps the body get rid of extra salt and water.
The person must have certain blood pressure levels: three measurements showing a top number (systolic) between 150 and 180 and a bottom number (diastolic) of 90 or more.
The doctor must believe the person can safely keep the same medication routine during the study period.
Women who can have children must agree to use birth control during the study.
The person must agree to all study procedures and be willing to attend all follow-up visits.
By the end of a specific period, the person must have kept the same medication routine for at least 4 weeks before the procedure.
By the end of a specific period, the person must meet certain blood pressure levels: three measurements showing a top number (systolic) between 150 and 180 and a bottom number (diastolic) of 90 or more, and a 24-hour average top number (systolic) between 135 and 170 with at least 70% valid readings.

Who cannot join the trial?

10 criteria

Patients who have a history of severe allergic reactions to the study medication or its components.
Individuals with a significant medical condition that could interfere with the study, such as severe heart disease.
Patients who are pregnant or breastfeeding.
Individuals who have participated in another clinical trial within the last 30 days.
Patients with a history of alcohol or drug abuse within the past year.
Individuals with a mental health condition that could affect their ability to follow study instructions.
Patients who have had a major surgery within the last 3 months.
Individuals with uncontrolled diabetes, which means their blood sugar levels are not well managed.
Patients with a history of kidney disease that affects their kidney function.
Individuals who are unable to give informed consent, meaning they cannot fully understand the study and agree to participate.

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Verified sites

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Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands

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Investigated drugs

Peregrine System™ Kit
is a medical device used in a procedure called renal denervation. This procedure aims to reduce high blood pressure by targeting the nerves in the kidneys. The Peregrine System™ Kit uses alcohol to disrupt these nerves, which can help lower blood pressure in patients whose hypertension is not well controlled with medications alone.
Antihypertensive Medications
are drugs used to help lower high blood pressure. In this trial, these medications are used in combination with the Peregrine System™ Kit to evaluate their combined effectiveness in managing hypertension. These medications work in various ways to relax blood vessels, reduce heart rate, or decrease the volume of blood, all of which help to lower blood pressure.

Ethanol, Anhydrous

What is already known about the treatment

Peregrine System™ Kit – This is a medical device used for renal denervation, a procedure aimed at treating hypertension. It is administered through a minimally invasive procedure where alcohol is used to disrupt nerve activity in the renal arteries. Currently, it is under investigation in clinical trials to assess its effectiveness in patients with uncontrolled high blood pressure, especially when combined with standard antihypertensive medications. The mechanism involves alcohol-mediated neurolysis, which targets the nerves to reduce their activity and subsequently lower blood pressure. This device is part of ongoing research and is not yet widely adopted in standard medical practice.

Investigated diseases

Hypertension – Hypertension, also known as high blood pressure, is a condition where the force of the blood against the artery walls is consistently too high. Over time, this increased pressure can cause damage to the blood vessels and organs, particularly the heart, brain, kidneys, and eyes. It often develops over many years and can go unnoticed due to a lack of symptoms. As it progresses, it can lead to complications such as heart disease, stroke, and kidney problems. Hypertension is typically diagnosed when blood pressure readings are consistently above the normal range. Managing blood pressure is crucial to prevent further health issues.