Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea
This study is ongoing, but not recruiting participants.
Sponsor:
Institute of Cardiology, Warsaw, Poland
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT01366625
First received: June 2, 2011
Last updated: November 27, 2014
Last verified: November 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Obstructive Sleep Apnea |
Device: Renal denervation with a catheter-based procedure (Symplicity® Catheter System) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Renal Denervation on Blood Pressure and Clinical Course of Obstructive Sleep Apnea in Patients With Resistant Hypertension |
Resource links provided by NLM:
Further study details as provided by Institute of Cardiology, Warsaw, Poland:
Primary Outcome Measures:
- Blood Pressure Reduction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Responses to renal denervation (e.g., blood pressure reduction, sleep apnea course, metabolic assessment, cardiac changes) [ Time Frame: Through 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Renal Denervation
Renal Denervation and maintenance of anti-hypertensive medications and continuous positive airway pressure therapy
|
Device: Renal denervation with a catheter-based procedure (Symplicity® Catheter System)
Disruption of the renal nerves with a catheter-based procedure.
Other Name: Renal Denervation (Symplicity® Catheter System)
|
|
No Intervention: Maintenance of Medications
Maintenance of anti-hypertensive medications and continuous positive airway pressure therapy
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- >= 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)
Exclusion Criteria:
- renal artery abnormalities
- eGFR < 60mL/min
- previous TIA, stroke, heart failure
- Type 1 diabetes
- ICD or pacemaker
- others
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366625
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366625
Locations
| Poland | |
| Institute of Cardiology | |
| Warsaw, Poland, 04-628 | |
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Investigators
| Principal Investigator: | Aleksander Prejbisz, M.D., Ph.D. | Institute of Cardiology |
More Information
| Responsible Party: | Institute of Cardiology, Warsaw, Poland |
| ClinicalTrials.gov Identifier: | NCT01366625 History of Changes |
| Other Study ID Numbers: | OSA-Denerv1 |
| Study First Received: | June 2, 2011 |
| Last Updated: | November 27, 2014 |
| Health Authority: | Poland: Ministry of Science and Higher Education |
Keywords provided by Institute of Cardiology, Warsaw, Poland:
|
hypertension, resistant obstructive sleep apnea renal denervation continuous positive airway pressure therapy |
Additional relevant MeSH terms:
|
Hypertension Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Vascular Diseases Cardiovascular Diseases Respiration Disorders |
Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on September 26, 2016