HypertensionREDUCE-HTNNCT01541865

Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter

A study testing Renal Denervation in people with Hypertension, run by Boston Scientific Corporation at 26 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The Study objective is to assess the performance of the Vessix V2 Renal Denervation System for the treatment of uncontrolled hypertension using an innovative percutaneous Radio Frequency (RF) balloon catheter renal denervation device. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hypertension
What is being tested?: Renal Denervation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 146 participants
Where: 26 sitesin 8 countries
Study dates: Feb 2012to Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who have provided written informed consent;
Subjects who are ≥ 18 years and ≤ 75 years of age;
Subjects who have Systolic Blood Pressure (SBP) ≥ 160 mm Hg based on an average of three (3) office-based blood pressure readings (seated) measured according to protocol;
Subjects with ≥ 3 anti-hypertensive drugs at maximally tolerated doses with stable regimen for at least 2 weeks prior to enrollment
Subjects with a estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m^2;
Suitable renal artery anatomy
Subjects who are willing and able to comply with all study procedures.

Who cannot join

Subjects with known/diagnosed secondary hypertension;
Subjects who are contraindicated for anticoagulation medications (heparin, aspirin, Angiomax, etc.), analgesic medications (morphine, fentanyl, etc.), anxiolytic medications (alprazolam, lorazepam, diazepam, etc.) or other medications required for an interventional procedure;
Subjects with known bleeding or hyper-coagulation disorders;
Subjects who have type 1 diabetes mellitus;
Subjects who have experienced a myocardial infarction, unstable angina pectoris, uncompensated heart failure, or a cerebrovascular accident within six (6) months prior to the screening visit, or have widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques;
Subjects who have planned percutaneous vascular or surgical intervention for any reason within the next 6 months;

Show all 22Show fewer

Subjects who have hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous;
Subjects who have an implantable cardioverter defibrillator, pacemaker, or clinically significant abnormal electrocardiogram
Subjects who have any serious medical condition, which in the opinion of the investigator, may adversely affect patient safety or the efficacy of the procedure in the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia);
Subjects who are pregnant, nursing or planning to become pregnant;
Subjects who have a known, unresolved history of drug use or alcohol abuse/dependency;
Subjects who are currently enrolled in any investigational study wherein patient participation has not been completed;
Subjects who, for any reason, may not be able to understand or comply with instructions;
Subjects who are contraindicated for intravascular contrast material;
Subjects who are currently taking estrogen or any estrogen-like compound.
Subjects who have had a prior renal denervation procedure
Subjects with prior intervention to right or left renal artery;
Subjects with ≥ 30% renal artery stenosis
Subjects with severe femoral, renal, iliac or aortic calcification that may cause a potential complication at the time of the procedure;
Subjects in which the physician is unable to safely cannulate the renal artery;
Subjects in which the physician is unable to percutaneously access the femoral artery;
Subjects with one kidney.

Trial locations and contacts

26 sites in 8 countries.

Country

City, postcode or hospital

26 sites in 8 countries

Germany9 sites

Zentralklinik Bad Berka GmbH
Bad Berka, 99437
Kardiologische Praxis Main-Taunus
Bad Soden/Taunus, 65812
Vascular Center Berlin, Ev. Königin Elisabeth Hospital
Berlin, 10365
St. Vincenz Krankenhaus Abt. Kardiologie
Essen, 45141
CardioVascular Center, Sankt Katharinen Krakenhaus
Frankfurt, 60389
Hamburg University Cardiovascular Center
Hamburg, 22527
Saarland University Hospital Department of Internal Medicine III Non-surgical Intensive Care, Cardiology and Angiology
Homburg/Saar, D-66421
University Leipzig
Leipzig, 04109
German Heart Center Munich
Münich, 80636

Other trials in Germany

Australia5 sites

Royal Adelaide Hospital
Adelaide, South Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, 5042
The Prince Charles Hospital, Cardiology Clinical Research Centre
Brisbane, Queensland, 4032
Monash Cardiovascular Research Centre (Monash Heart)
Clayton, Victoria, 3168
St. Vincent's Hospital
Sydney, New South Wales, 2010

Other trials in Australia

Austria2 sites

AKH Linz
Linz, 4020
Salzburger Landeskliniken Universitats Krankenhaus
Salzburg, A-5020

Other trials in Austria

Belgium2 sites

OLV Ziekenhuis
Aalst
Cliniques Universiaires Saint-Luc
Brussels

Other trials in Belgium

France2 sites

Hôpital Européen Georges Pompidou
Paris
Clinic Pasteur
Toulouse, F-31076

Other trials in France

Netherlands2 sites

Academic Medical Center
Amsterdam, 1105AZ
Erasmus Medical Center-Thorax Center
Rotterdam, 3015CE

Other trials in Netherlands

New Zealand2 sites

Mercy Angiography Unit Ltd
Auckland, 1023
Auckland City Hospital
Grafton, Auckland, 1023

Other trials in New Zealand

Switzerland2 sites

University Hospital of Geneva, Cardiology Center
Geneva, 1211
Switzerland University Hospital Clinic for Cardiology
Zurich, 8091

Other trials in Switzerland

About this study

Official title: Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN) - POST MARKET APPROVAL CLINICAL SURVEILLANCE STUDY

Read the detailed description

This study will evaluate the hypothesis that the Vessix V2 Renal Denervation System can be employed to reduce systolic and diastolic blood pressure at 6 months as compared to pre-treatment baseline blood pressures.

Patient blood pressure will be measured by in the office according to recognized international techniques and standards.

Procedural success shall be defined as ability to complete the renal denervation treatment using the V2 balloon catheter device and RF generator.

Conditions: Hypertension
Being tested: Renal Denervation
Keywords: hypertension, renal denervation, uncontrolled hypertension, medication resistant hypertension
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Renal DenervationDevice
Also called Vessix V2 Renal Denervation System
percutaneous renal denervation using the Vessix RF balloon catheter

Study groups in NCT01541865
Study group	Role	What they receive
Renal Denvervation	Other	All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System. Receives: Device: Renal Denervation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment
Change in systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment following therapeutic renal denervation compared to baseline. Office blood pressure will be measured using a validated electronic device according to a standardized procedure. .
Measured: Baseline and 6 months
Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure
Change in systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring (ABPM) following therapeutic renal denervation compared to baseline using a validated ABPM device.
Measured: Baseline and 6 months

Secondary outcomes (10)

Absence of Flow Limiting Stenosis in the Renal Artery
Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound
Measured: 6 months
Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery
Measured: Duration of the procedure (average of 65 minutes)
Renal Artery Infarction or Embolus
Measured: Duration of the procedure (average of 65 minutes)
Cerebrovascular Accident (CVA) at Time of Procedure
Measured: Duration of the procedure (average of 65 minutes)
Myocardial Infarction at Time of Procedure
Measured: Duration of the procedure (average of 65 minutes)
Sudden Cardiac Death at Time of Procedure
Measured: Duration of the procedure (average of 65 minutes)
Angiographically-documented Renal Stenosis Requiring an Intervention
Measured: 2 Years
Chronic Symptomatic Orthostatic Hypotension
Measured: 2 Years
Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance)
Measured: 2 Years
Reduction in Estimated Glomerular Filtration Rate (eGFR) >25%
Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Jun 2015

First posted1 Mar 2012 (estimated)
Study startFeb 2012
Primary completionNov 2013
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 146 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01541865
Sponsor's protocol ID: CR002-020
Acronym: REDUCE-HTN
Status last verified: Oct 2015
First submitted: 21 Feb 2012
Last updated: 25 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Sievert H, Schofer J, Ormiston J, Hoppe UC, Meredith IT, Walters DL, Azizi M, Diaz-Cartelle J, Cohen-Mazor M. Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study. EuroIntervention. 2015 Feb;10(10):1213-20. doi: 10.4244/EIJY14M12_01.
PubMed 25452197
Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323. No abstract available.
PubMed 25186534

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN) - POST MARKET APPROVAL CLINICAL SURVEILLANCE STUDY
ClinicalTrials.gov ID: NCT01541865
Acronym / sponsor ID: REDUCE-HTN / CR002-020
Conditions: Hypertension
Keywords: hypertension, renal denervation, uncontrolled hypertension, medication resistant hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 146 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Nov 2013 (actual)
Study completion: Jun 2015 (actual)
First posted: 1 Mar 2012 (estimated)
Results: Posted 16 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Patient blood pressure will be measured by in the office according to recognized international techniques and standards.

Procedural success shall be defined as ability to complete the renal denervation treatment using the V2 balloon catheter device and RF generator.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Renal Denvervation	Other	Device: Renal DenervationAll subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subjects who have provided written informed consent;
Subjects who are ≥ 18 years and ≤ 75 years of age;
Subjects who have Systolic Blood Pressure (SBP) ≥ 160 mm Hg based on an average of three (3) office-based blood pressure readings (seated) measured according to protocol;
Subjects with ≥ 3 anti-hypertensive drugs at maximally tolerated doses with stable regimen for at least 2 weeks prior to enrollment
Subjects with a estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m^2;

Key exclusion criteria (22 listed)

Subjects with known/diagnosed secondary hypertension;
Subjects who are contraindicated for anticoagulation medications (heparin, aspirin, Angiomax, etc.), analgesic medications (morphine, fentanyl, etc.), anxiolytic medications (alprazolam, lorazepam, diazepam, etc.) or other medications required for an interventional procedure;
Subjects with known bleeding or hyper-coagulation disorders;
Subjects who have type 1 diabetes mellitus;
Subjects who have experienced a myocardial infarction, unstable angina pectoris, uncompensated heart failure, or a cerebrovascular accident within six (6) months prior to the screening visit, or have widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Renal DenervationAlso: Vessix V2 Renal Denervation Systempercutaneous renal denervation using the Vessix RF balloon catheter	Device	Renal Denvervation

Primary outcome

Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment
Time frame: Baseline and 6 months
Change in systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment following therapeutic renal denervation compared to baseline. Office blood pressure will be measured using a validated electronic device according to a standardized procedure. .
Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure
Time frame: Baseline and 6 months
Change in systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring (ABPM) following therapeutic renal denervation compared to baseline using a validated ABPM device.

10 secondary outcomes

Absence of Flow Limiting Stenosis in the Renal Artery
Time frame: 6 months
Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery
Time frame: Duration of the procedure (average of 65 minutes)
Renal Artery Infarction or Embolus
Time frame: Duration of the procedure (average of 65 minutes)
Cerebrovascular Accident (CVA) at Time of Procedure
Time frame: Duration of the procedure (average of 65 minutes)
Myocardial Infarction at Time of Procedure
Time frame: Duration of the procedure (average of 65 minutes)
Sudden Cardiac Death at Time of Procedure
Time frame: Duration of the procedure (average of 65 minutes)
Angiographically-documented Renal Stenosis Requiring an Intervention
Time frame: 2 Years
Chronic Symptomatic Orthostatic Hypotension
Time frame: 2 Years
Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance)
Time frame: 2 Years
Reduction in Estimated Glomerular Filtration Rate (eGFR) >25%
Time frame: 2 Years

Results and safety

Results posted to the registry on 16 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Renal Denervation	146	124

Primary outcome: Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: mm Hg

Measure	Renal Denervation n = 143
Systolic	-24.5 (22.1)
Diastolic	-10.3 (12.7)

Population analysed: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 3 participants were not evaluable.

Primary outcome: Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: mm Hg

Measure	Renal Denervation n = 70
Systolic	-8.0 (14.6)
Diastolic	-5.7 (9.2)

Population analysed: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 76 participants were not evaluable at either the baseline or 6 month assessment.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collect through the 2 year follow up visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Renal Denervation	69 of 146 (47.3%)	70 of 146 (47.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25452197Sievert H, Schofer J, Ormiston J, Hoppe UC, Meredith IT, Walters DL, Azizi M, Diaz-Cartelle J, Cohen-Mazor M. Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study. EuroIntervention. 2015 Feb;10(10):1213-20. doi: 10.4244/EIJY14M12_01.
Results publication: PubMed 25186534Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323. No abstract available.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Horst Sievert, M.D. principal investigator

CardioVascular Center Frankfurt, Germany

26 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Renal Denervation in people with Hypertension, run by Boston Scientific Corporation at 26 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Germany, Australia, Austria, Belgium, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01541865, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2015.