HypertensionNCT01366625
Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea
A study testing Renal denervation with a catheter-based procedure (Symplicity® Catheter System) in people with Hypertension and Obstructive Sleep Apnea, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of resistant hypertension coexisting with obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension, Obstructive Sleep Apnea
- What is being tested?
- Renal denervation with a catheter-based procedure (Symplicity® Catheter System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2011to 28 Nov 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 18 and =< 70 years of age.
- systolic blood pressure >=140mmHg (office);
- on 3 or more antihypertensive medications (including diuretic)
- mean daytime systolic ABPM >= 135 mmHg
- obstructive sleep apnea (AHI >=15 event/hour, indications for CPAP treatment)
Who cannot join
- renal artery abnormalities
- eGFR < 60mL/min
- previous TIA, stroke, heart failure
- Type 1 diabetes
- ICD or pacemaker
- others
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Renal Denervation on Blood Pressure and Clinical Course of Obstructive Sleep Apnea in Patients With Resistant Hypertension
The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of resistant hypertension coexisting with obstructive sleep apnea.
- Conditions
- Hypertension, Obstructive Sleep Apnea
- Being tested
- Renal denervation with a catheter-based procedure (Symplicity® Catheter System)
- Keywords
- hypertension, resistant, obstructive sleep apnea, renal denervation, continuous positive airway pressure therapy
- Medical subject headings
- Hypertension, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervation with a catheter-based procedure (Symplicity® Catheter System)Device
Also called Renal Denervation (Symplicity® Catheter System)
Disruption of the renal nerves with a catheter-based procedure.
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Experimental | Renal Denervation and maintenance of anti-hypertensive medications and continuous positive airway pressure therapy Receives: Device: Renal denervation with a catheter-based procedure (Symplicity® Catheter System) |
| Maintenance of Medications | No intervention | Maintenance of anti-hypertensive medications and continuous positive airway pressure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Reduction
Measured: 3 months
Secondary outcomes (1)
Responses to renal denervation (e.g., blood pressure reduction, sleep apnea course, metabolic assessment, cardiac changes)
Measured: Through 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startJul 2011
- Primary completion8 Feb 2016
- Study completion28 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksander Prejbisz, M.D., Ph.D., Principal investigator, Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366625
- Sponsor's protocol ID
- OSA-Denerv1
- Status last verified
- Jan 2017
- First submitted
- 2 Jun 2011
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Warchol-Celinska E, Prejbisz A, Kadziela J, Florczak E, Januszewicz M, Michalowska I, Dobrowolski P, Kabat M, Sliwinski P, Klisiewicz A, Topor-Madry R, Narkiewicz K, Somers VK, Sobotka PA, Witkowski A, Januszewicz A. Renal Denervation in Resistant Hypertension and Obstructive Sleep Apnea: Randomized Proof-of-Concept Phase II Trial. Hypertension. 2018 Aug;72(2):381-390. doi: 10.1161/HYPERTENSIONAHA.118.11180. Epub 2018 Jun 25.
PubMed 29941516
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Renal Denervation on Blood Pressure and Clinical Course of Obstructive Sleep Apnea in Patients With Resistant Hypertension
- ClinicalTrials.gov ID
- NCT01366625
- Acronym / sponsor ID
- OSA-Denerv1
- Conditions
- Hypertension, Obstructive Sleep Apnea
- Keywords
- hypertension, resistant, obstructive sleep apnea, renal denervation, continuous positive airway pressure therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- 8 Feb 2016 (actual)
- Study completion
- 28 Nov 2016 (actual)
- First posted
- 6 Jun 2011 (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 purpose of this study is to investigate the clinical utility of renal denervation for the treatment of resistant hypertension coexisting with obstructive sleep apnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation | Experimental | Device: Renal denervation with a catheter-based procedure (Symplicity® Catheter System)Renal Denervation and maintenance of anti-hypertensive medications and continuous positive airway pressure therapy |
| Maintenance of Medications | No intervention | –Maintenance of anti-hypertensive medications and continuous positive airway pressure therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >= 18 and =< 70 years of age.
- systolic blood pressure >=140mmHg (office);
- on 3 or more antihypertensive medications (including diuretic)
- mean daytime systolic ABPM >= 135 mmHg
- obstructive sleep apnea (AHI >=15 event/hour, indications for CPAP treatment)
Key exclusion criteria (6 listed)
- renal artery abnormalities
- eGFR < 60mL/min
- previous TIA, stroke, heart failure
- Type 1 diabetes
- ICD or pacemaker
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 denervation with a catheter-based procedure (Symplicity® Catheter System)Also: Renal Denervation (Symplicity® Catheter System)Disruption of the renal nerves with a catheter-based procedure. | Device | Renal Denervation |
Primary outcome
Blood Pressure Reduction
Time frame: 3 months
1 secondary outcome
Responses to renal denervation (e.g., blood pressure reduction, sleep apnea course, metabolic assessment, cardiac changes)
Time frame: Through 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Derived from this study: PubMed 29941516Warchol-Celinska E, Prejbisz A, Kadziela J, Florczak E, Januszewicz M, Michalowska I, Dobrowolski P, Kabat M, Sliwinski P, Klisiewicz A, Topor-Madry R, Narkiewicz K, Somers VK, Sobotka PA, Witkowski A, Januszewicz A. Renal Denervation in Resistant Hypertension and Obstructive Sleep Apnea: Randomized Proof-of-Concept Phase II Trial. Hypertension. 2018 Aug;72(2):381-390. doi: 10.1161/HYPERTENSIONAHA.118.11180. Epub 2018 Jun 25.
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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.
Aleksander Prejbisz, M.D., Ph.D. principal investigator
Institute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal denervation with a catheter-based procedure (Symplicity® Catheter System) in people with Hypertension and Obstructive Sleep Apnea, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 5 inclusion and 6 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood Pressure Reduction (time frame: 3 months). 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 NCT01366625, which also lists 1 linked publication.
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 26 Jan 2017.