Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea

January 25, 2017 updated by: Institute of Cardiology, Warsaw, Poland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 04-628
        • Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Renal Denervation (Symplicity® Catheter System)
No Intervention: Maintenance of Medications
Maintenance of anti-hypertensive medications and continuous positive airway pressure therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood Pressure Reduction
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Responses to renal denervation (e.g., blood pressure reduction, sleep apnea course, metabolic assessment, cardiac changes)
Time Frame: Through 1 year
Through 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cardiology, Warsaw, Poland

Investigators

  • Principal Investigator: Aleksander Prejbisz, M.D., Ph.D., Institute of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2011

Primary Completion (Actual)

February 8, 2016

Study Completion (Actual)

November 28, 2016

Study Registration Dates

First Submitted

June 2, 2011

First Submitted That Met QC Criteria

June 3, 2011

First Posted (Estimate)

June 6, 2011

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSA-Denerv1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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