NCT01771406

Brief Summary

The aim of this study is to examine how effective CPAP treatment and treatment with nebivolol are respectively on reducing blood pressure and on endothelial dysfunction in patients suffering from obstructive sleep apnea and hypertension.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Feb 2013

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

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

September 5, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

January 18, 2013

Status Verified

August 1, 2012

Enrollment Period

3 years

First QC Date

September 5, 2012

Last Update Submit

January 15, 2013

Conditions

HypertensionEndothelial DysfunctionObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • change in mean arterial blood pressure

    measurement assessed at w8,w14,w22

Secondary Outcomes (1)

  • change in endothelial function

    measurement assessed at w8,w14,w22

Study Arms (2)

Nebivolol then CPAP

EXPERIMENTAL

8 weeks of Nebivolol treatment (5m/day), 6 weeks of washout, 8 weeks of CPAP and if the patient is still hypertensive 8 weeks of Nebivolol plus CPAP treatment

Drug: NebivololDevice: Continuous positive airway pressure (CPAP)

CPAP then Nebivolol

EXPERIMENTAL

8 weeks of CPAP treatment, 6 weeks of washout, 8 weeks of Nebivolol and if the patient is still hypertensive 8 weeks of Nebivolol plus CPAP treatment

Drug: NebivololDevice: Continuous positive airway pressure (CPAP)

Interventions

NebivololDRUG

8 weeks of Nebivolol treatment (5mg/day)

CPAP then NebivololNebivolol then CPAP
Continuous positive airway pressure (CPAP)DEVICE

8 weeks of CPAP treatment

Also known as: Philips Respironics Remstar System One
CPAP then NebivololNebivolol then CPAP

Eligibility Criteria

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

You may qualify if:

  • male/female ≥ 18 years old
  • patient with obstructive sleep apnea (apnea-hypopnea index ≥ 20) naïve for CPAP treatment
  • patient with weak or moderate hypertension (140 \<= systolic blood pressure (SBP) \< 180 mmHg and 90 \<= diastolic blood pressure (DBP) \< 110 mmHg naïve for any antihypertensive treatment
  • negative pregnancy test
  • ambulatory patient
  • patient who have signed the informed consent form
  • patient affiliated to social security

You may not qualify if:

  • pregnant or nursing woman
  • acute hepatic failure, biliary cirrhosis, cholestasis
  • clearance of Cockcroft \< 30 ml/min/1.73m2
  • sick sinus syndrome, including sino-atrial block
  • second and third degree heart block (without a pacemaker)
  • history of bronchospasm and bronchial asthma
  • bradycardia (heart rate\< 60bpm prior to start therapy)
  • severe peripheral circulatory disturbances
  • acute hypertension (SBP\>= 180 mmHg and/or DBP \>= 110 mmHg)
  • severe daytime sleepiness (Epworth rating scale \> 15)
  • known cardiovascular pathologies
  • contraindication to CPAP
  • allergy to nebivolol
  • patient treated with antihypertensive drug(s), with class I antiarrhythmics (quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone)
  • patient treated with CPAP
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

HypertensionSleep Apnea, Obstructive

Interventions

NebivololContinuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPositive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Catharina Belge, M.D., Ph.D.

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catharina Belge, M.D., Ph. D.

CONTACT

+3216342520secretariaat.slaaplabo@uzleuven.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2012

First Posted

January 18, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

January 18, 2013

Record last verified: 2012-08

Locations

BE(1)