NCT01366625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
25 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2016

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

4.6 years

First QC Date

June 2, 2011

Last Update Submit

January 25, 2017

Conditions

HypertensionObstructive Sleep Apnea

Keywords

hypertension, resistantobstructive sleep apnearenal denervationcontinuous positive airway pressure therapy

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure Reduction

    3 months

Secondary Outcomes (1)

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

    Through 1 year

Study Arms (2)

Renal Denervation

EXPERIMENTAL

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)

Maintenance of Medications

NO INTERVENTION

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

Interventions

Renal denervation with a catheter-based procedure (Symplicity® Catheter System)DEVICE

Disruption of the renal nerves with a catheter-based procedure.

Also known as: Renal Denervation (Symplicity® Catheter System)
Renal Denervation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>= 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)

You may not qualify if:

  • renal artery abnormalities
  • eGFR \< 60mL/min
  • previous TIA, stroke, heart failure
  • Type 1 diabetes
  • ICD or pacemaker
  • others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Cardiology

Warsaw, 04-628, Poland

Location

Related Publications (1)

  • 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.

    PMID: 29941516DERIVED

MeSH Terms

Conditions

HypertensionSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Aleksander Prejbisz, M.D., Ph.D.

    Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 6, 2011

Study Start

July 1, 2011

Primary Completion

February 8, 2016

Study Completion

November 28, 2016

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

PL(1)