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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Clinique Pasteur	Toulouse	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Medical University Of Graz	Graz	Austria
University Hospital Maastricht	Maastricht	The Netherlands
Universitaet Leipzig	Leipzig	Germany
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Klinikum Coburg GmbH	Coburg	Germany
Gesundheit Nord gGmbH Klinikverbund Bremen	Bremen	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Saarland University Hospital	Homburg	Germany
University Hospital Galway	Galway	Ireland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
CHC MontLegia	Liege	Belgium
American Heart Of Poland S.A.	Kedzierzyn-Kozle	Poland
Ziekenhuis Oost Limburg	Genk	Belgium
Centre Hospitalier De Pau	Pau	France
Uniklinikum Salzburg	Salzburg	Austria
CardioVasculäres Centrum (CVC) Frankfurt	Frankfurt	Germany
Ceuckvxwg Ubfaamhqxxtgmj Ssfehllov	Woluwe-Saint-Lambert	Belgium
Uiibayzntyxd Mnavego Cwkjhng Gdzsvzoib	Groningen	The Netherlands
Sqkk Kdqrkzzq Ltpeqxr Gtgg	Luebeck	Germany
Ikqignekx	Lille	France
Oufwnxosfeaincaysiwaxnmngl	Aalst	Belgium
Utnqjnotzv Hsvffgdw Cwjehsh	Cologne	Germany
Aivvjmlgls Pansdtgj Hufgzgvl Dx Mczgosyyo	Marseille	France
Erryftd Uojsopzlvkuf Mbevbwb Cneqosd Rierrjfnb (ryupijw Mnk	Rotterdam	The Netherlands
Cdqdtm Cppuynd Gag	Bremen	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	18.02.2020
Belgium	Not recruiting	18.02.2020
France	Not recruiting	18.02.2020
Germany	Not recruiting	18.02.2020
Ireland	Not recruiting	18.02.2020
Poland	Not recruiting	18.02.2020
The Netherlands	Not recruiting	18.02.2020

Trial locations

Investigated drugs:

Ethanol, Anhydrous

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.

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.

Trial ID:

2024-512525-83-00

Protocol code:

CR0002

NCT ID:

NCT02910414

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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