Hypertension Resistant to Conventional TherapyNCT02690909
A Study to Evaluate Safety and Efficacy of the Redy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension
A study testing Redy™ Renal Denervation System in people with Hypertension Resistant to Conventional Therapy, run by Renal Dynamics GmbH at 10 sites in 8 countries.
Trial summary
The ReDy™ System (Renal Dynamics) is a renal denervation device incorporating a variety of ablation features and technical improvements over previously designed systems into a single product. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension Resistant to Conventional Therapy
- What is being tested?
- Redy™ Renal Denervation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 10 sitesin 8 countries
- Study dates
- Apr 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient has established hypertension (diagnosed ≥12 months prior to screening) and is on a guideline based stable drug regimen (≥ 4 weeks), consisting of ≥3 anti-hypertensive medications of different classes including a diuretic;
- Office systolic blood pressure >150 mmHg;
- Patient has (under directly observed therapy) average daytime systolic blood pressure values > 140 mmHg by 24h ambulatory blood pressure monitoring;
- Patient is ≥ 18 and ≤ 75 years of age at time of consent;
- Patient must be able and willing to comply with the required follow-up schedule;
- Patient must be able and willing to provide written informed consent;
Who cannot join
- Patient has known significant reno-vascular abnormalities such as renal artery stenosis > 30%;
- Patient has "Isolated Systolic Hypertension" with a diastolic blood pressure < 90 mmHg;
- Evidence or history of secondary hypertension, other than sleep apnea syndrome;
- Patient has a history of prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent graft placement;
- Patient has significant valvular heart disease;
- Patient has known coagulation abnormalities;
Show all 15Show fewer
- Patient life expectancy is < 12 months, as estimated by the study Investigator;
- Patient is participating in another clinical study, which is before its primary endpoint and/or has the potential to impact his/her hypertension management (pharmaceutical / device);
- Patient is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods;
- Patient has active systemic infection;
- Patient has small <4.0 mm in diameter, large >6.5 mm in diameter or short <20.0 mm in length, multiple main, or highly tortuous renal arteries;
- Patient has impaired renal function with an estimated GFR <45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula;
- Patient had a renal transplant or is awaiting a renal transplant;
- Patient has a known intolerance for x-ray contrast agent that cannot be adequately controlled with pre-medication;
- Any medical condition as estimated by the Study Investigator that may harm patient or jeopardize study participation, the interpretation of study results or may impede the ability to obtain informed consent (e.g., mental condition);
Trial locations and contacts
10 sites in 8 countries.
10 sites in 8 countries
Belgium2 sites, 2 recruiting
- Not yet recruiting
OLV Onze-Lieve-Vrouwziekenhuis
Aalst
Eric Wyffels, Dr.
William Wijns, Dr.
- Not yet recruiting
ZNA Middelheim Hospital
Antwerp
Stefan Verheye, Dr.
Germany2 sites, 2 recruiting
- Not yet recruiting
Asklepios Klinik St. Georg
Hamburg
Felix Meincke, Dr.
Karl-Heinz Kuck, Prof. Dr.
- Not yet recruiting
Saarland University Medical Center
Homburg
Felix Mahfoud, PD Dr.
Hans Maurer, Prof. Dr.
Hungary1 site, 1 recruiting
- Not yet recruiting
Semmelweis University
Budapest
Bela Merkely, Prof. Dr.
Peter Perge, Dr.
Ireland1 site, 1 recruiting
- Not yet recruiting
Galway University Hospital
Galway
Faisal Sharif, Dr.
Israel1 site, 1 recruiting
- Recruiting
Kaplan Medical Center
Rehovot
Michael Jonas, Dr.
Poland1 site, 1 recruiting
- Recruiting
The Cardinal Stefan Wyszyński Institute of Cardiology
Warsaw
Adam Witkowski, Prof. Dr.
Russia1 site, 1 recruiting
- Recruiting
Academician E.N. Meshalkin Novosibirsk State Research Institute of Circulation Pathology
Novosibirsk
Evgeny Pokushalov, Dr.
Serbia1 site, 1 recruiting
- Not yet recruiting
KCS Clinical Center of Serbia
Belgrade
Goran Stankovic, Dr.
About this study
Official title: A Prospective, Post-marketing, Single-arm, Open Label, Multi-center Clinical Study to Evaluate the Safety and Efficacy of the ReDy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension
The ReDy™ System (Renal Dynamics) is a renal denervation device incorporating a variety of ablation features and technical improvements over previously designed systems into a single product. It is intended to treat uncontrolled (drug-resistant) hypertension by RF ablation of the sympathetic nerve network surrounding the renal arteries.
This study will be carried out to validate the safety and the efficacy of the ReDy™ Renal Denervation device and to demonstrate that it performs according to its intended use, i.e. the treatment of patients with uncontrolled hypertension.
- Being tested
- Redy™ Renal Denervation System
- Keywords
- Uncontrolled Hypertension, Resistant Hypertension, Renal Denervation
- Medical subject headings
- Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redy™ Renal Denervation SystemDevice
Renal Denervation System
| Study group | Role | What they receive |
|---|---|---|
| Redy™ Renal Denervation System | Experimental | Renal Denervation System Receives: Device: Redy™ Renal Denervation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-related adverse events at 1-month follow-up post treatment
Incidence of device-related Adverse Events at 1-month follow-up post treatment
Measured: 1-month post treatment
Secondary outcomes (6)
Peri-procedural Adverse Events at 1-month follow-up post treatment
Incidence of peri-procedural Adverse Events at 1-month follow-up post treatment
Measured: 1-month post treatment
Device-related Adverse Events at 3 and 6 months follow-up post treatment
Incidence of device-related Adverse Events at 3 and 6 months follow-up post treatment
Measured: 3 and 6 months post treatment
Reduction of average systolic daytime blood pressure assessed by 24h ABPM at 3-months
Reduction of average systolic daytime blood pressure as assessed by 24h ambulatory blood pressure monitoring at 3-month compared to baseline
Measured: 3 months post treatment
Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment
Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment
Measured: 1, 3 and 6 months post treatment
Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment
Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment
Measured: 1, 3 and 6 months post treatment
Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment
Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment
Measured: 1, 3 and 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension Resistant to Conventional TherapyStudies of the same condition, open and under way.
- 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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renal Dynamics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biosensors Europe SA, Physio-Logic Ltd. Israel, AmeRuss Clinical Trials LLC, USA
- Responsible party
- Sponsor
- Investigators
- Felix Mahfoud, MD, Principal investigator, Saarland University Medical Center Homburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690909
- Sponsor's protocol ID
- RD1501
- Status last verified
- May 2016
- First submitted
- 19 Feb 2016
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Post-marketing, Single-arm, Open Label, Multi-center Clinical Study to Evaluate the Safety and Efficacy of the ReDy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension
- ClinicalTrials.gov ID
- NCT02690909
- Acronym / sponsor ID
- RD1501
- Keywords
- Uncontrolled Hypertension, Resistant Hypertension, Renal Denervation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Renal Dynamics GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Biosensors Europe SA, Physio-Logic Ltd. Israel, AmeRuss Clinical Trials LLC, USA
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ReDy™ System (Renal Dynamics) is a renal denervation device incorporating a variety of ablation features and technical improvements over previously designed systems into a single product. It is intended to treat uncontrolled (drug-resistant) hypertension by RF ablation of the sympathetic nerve network surrounding the renal arteries.
This study will be carried out to validate the safety and the efficacy of the ReDy™ Renal Denervation device and to demonstrate that it performs according to its intended use, i.e. the treatment of patients with uncontrolled hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Redy™ Renal Denervation System | Experimental | Device: Redy™ Renal Denervation SystemRenal Denervation System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has established hypertension (diagnosed ≥12 months prior to screening) and is on a guideline based stable drug regimen (≥ 4 weeks), consisting of ≥3 anti-hypertensive medications of different classes including a diuretic;
- Office systolic blood pressure >150 mmHg;
- Patient has (under directly observed therapy) average daytime systolic blood pressure values > 140 mmHg by 24h ambulatory blood pressure monitoring;
- Patient is ≥ 18 and ≤ 75 years of age at time of consent;
- Patient must be able and willing to comply with the required follow-up schedule;
Key exclusion criteria (15 listed)
- Patient has known significant reno-vascular abnormalities such as renal artery stenosis > 30%;
- Patient has "Isolated Systolic Hypertension" with a diastolic blood pressure < 90 mmHg;
- Evidence or history of secondary hypertension, other than sleep apnea syndrome;
- Patient has a history of prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent graft placement;
- Patient has significant valvular heart disease;
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 |
|---|---|---|
| Redy™ Renal Denervation SystemRenal Denervation System | Device | Redy™ Renal Denervation System |
Primary outcome
Device-related adverse events at 1-month follow-up post treatment
Time frame: 1-month post treatment
Incidence of device-related Adverse Events at 1-month follow-up post treatment
6 secondary outcomes
Peri-procedural Adverse Events at 1-month follow-up post treatment
Time frame: 1-month post treatment
Device-related Adverse Events at 3 and 6 months follow-up post treatment
Time frame: 3 and 6 months post treatment
Reduction of average systolic daytime blood pressure assessed by 24h ABPM at 3-months
Time frame: 3 months post treatment
Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment
Time frame: 1, 3 and 6 months post treatment
Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment
Time frame: 1, 3 and 6 months post treatment
Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment
Time frame: 1, 3 and 6 months post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Individual participant dataSharing planned: No
Related trials for Hypertension Resistant to Conventional Therapy
RecruitingPhase 4
Antihypertensive Mechanisms of Minocycline in Resistant Hypertension
Hypertension, Resistant to Conventional Therapy
Not yet recruiting
Expand Management of Blood Pressure With Renal Denervation in Patients Undergoing Staged PCI for Advanced Coronary Artery diseasE
Multivessel Coronary Artery Disease, Hypertension Resistant to Conventional Therapy
Recruiting
Physical Activity Program for Reducing Blood Pressure in Sleep Apnea Patients With Resistant Hypertension
Hypertension, Resistant to Conventional Therapy, Sleep Apnea
Active, not recruiting
RADIANCE Continued Access Protocol
Hypertension, Hypertension, Resistant to Conventional Therapy
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.
Felix Mahfoud, MD principal investigator
Saarland University Medical Center Homburg, Germany
10 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Redy™ Renal Denervation System in people with Hypertension Resistant to Conventional Therapy, run by Renal Dynamics GmbH at 10 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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium, Germany, Hungary, Ireland, Israel 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erifyli Kalloudi (+41(0)218048000 ext. 143, e.kalloudi@biosensors.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-related adverse events at 1-month follow-up post treatment (time frame: 1-month post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2016.