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Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea

Primary Purpose

Hypertension, Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Renal denervation with a catheter-based procedure (Symplicity® Catheter System)
Sponsored by
National Institute of Cardiology, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, resistant, obstructive sleep apnea, renal denervation, continuous positive airway pressure therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Renal Denervation

Maintenance of Medications

Arm Description

Renal Denervation and maintenance of anti-hypertensive medications and continuous positive airway pressure therapy

Maintenance of anti-hypertensive medications and continuous positive airway pressure therapy

Outcomes

Primary Outcome Measures

Blood Pressure Reduction

Secondary Outcome Measures

Responses to renal denervation (e.g., blood pressure reduction, sleep apnea course, metabolic assessment, cardiac changes)

Full Information

First Posted
June 2, 2011
Last Updated
January 25, 2017
Sponsor
National Institute of Cardiology, Warsaw, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT01366625
Brief Title
Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea
Official Title
Effects of Renal Denervation on Blood Pressure and Clinical Course of Obstructive Sleep Apnea in Patients With Resistant Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (Actual)
Primary Completion Date
February 8, 2016 (Actual)
Study Completion Date
November 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Cardiology, Warsaw, Poland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Obstructive Sleep Apnea
Keywords
hypertension, resistant, obstructive sleep apnea, renal denervation, continuous positive airway pressure therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal Denervation
Arm Type
Experimental
Arm Description
Renal Denervation and maintenance of anti-hypertensive medications and continuous positive airway pressure therapy
Arm Title
Maintenance of Medications
Arm Type
No Intervention
Arm Description
Maintenance of anti-hypertensive medications and continuous positive airway pressure therapy
Intervention Type
Device
Intervention Name(s)
Renal denervation with a catheter-based procedure (Symplicity® Catheter System)
Other Intervention Name(s)
Renal Denervation (Symplicity® Catheter System)
Intervention Description
Disruption of the renal nerves with a catheter-based procedure.
Primary Outcome Measure Information:
Title
Blood Pressure Reduction
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Responses to renal denervation (e.g., blood pressure reduction, sleep apnea course, metabolic assessment, cardiac changes)
Time Frame
Through 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksander Prejbisz, M.D., Ph.D.
Organizational Affiliation
Institute of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Cardiology
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29941516
Citation
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.
Results Reference
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Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea

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