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NCT01366625 Clinical Trial

Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea

Hypertension Clinical Trial

Official title:
Effects of Renal Denervation on Blood Pressure and Clinical Course of Obstructive Sleep Apnea in Patients With Resistant Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01366625
Other study ID # OSA-Denerv1
Secondary ID
Status Completed
Phase N/A
First received June 2, 2011
Last updated January 25, 2017
Start date July 2011
Est. completion date November 28, 2016

Study information
Verified date January 2017
Source Institute of Cardiology, Warsaw, Poland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date November 28, 2016
Est. primary completion date February 8, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Renal denervation with a catheter-based procedure (Symplicity® Catheter System)
Disruption of the renal nerves with a catheter-based procedure.

Locations
Country Name City State
Poland Institute of Cardiology Warsaw

Sponsors (1)
Lead Sponsor Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood Pressure Reduction 3 months
Secondary Responses to renal denervation (e.g., blood pressure reduction, sleep apnea course, metabolic assessment, cardiac changes) Through 1 year
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