Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Institute of Cardiology, Warsaw, Poland

ClinicalTrials.gov Identifier:

NCT01366625

First received: June 2, 2011

Last updated: January 25, 2017

Last verified: January 2017

History of Changes

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
Hypertension Obstructive Sleep Apnea	Device: Renal denervation with a catheter-based procedure (Symplicity® Catheter System)


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (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:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:

Blood Pressure Reduction [ Time Frame: 3 months ]

Secondary Outcome Measures:

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


Enrollment:	60
Actual Study Start Date:	July 2011
Study Completion Date:	November 28, 2016
Primary Completion Date:	February 8, 2016 (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)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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:	January 25, 2017

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 20, 2017

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