NCT00812695

Brief Summary

Obstructive sleep apnea (OSA) is an important cause of refractory hypertension but the impact of treatment with continuous positive airway pressure (CPAP) is not completely understood. The aim of this project is to study the effects of CPAP on blood pressure control and its influences on cardiac remodeling and arterial stiffness in patients with refractory hypertension and moderate or severe OSA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

2.4 years

First QC Date

December 19, 2008

Last Update Submit

November 21, 2011

Conditions

Obstructive Sleep ApneaRefractory Hypertension

Keywords

Obstructive sleep apneaRefractory hypertensionHeart remodelingArterial stiffnessCPAP

Outcome Measures

Primary Outcomes (1)

  • Ambulatory blood pressure monitoring

    Change from Baseline in Blood Pressure at 6 months

Secondary Outcomes (2)

  • Change from Baseline in Arterial stiffness at 6 months

    baseline and 6 months

  • change from baseline in heart remodeling at 6 months

    baseline and 6 months

Study Arms (2)

1

NO INTERVENTION

2

ACTIVE COMPARATOR

CPAP

Device: CPAP

Interventions

CPAPDEVICE

Gold standard treatment for Obstructive sleep apnea

2

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Refractory hypertensive patients with moderate-to-severe OSA, aged between 30 to 65 years old.

You may not qualify if:

  • Aortic, heart and valve diseases
  • Renal failure
  • Other identifiable causes of hypertension, no adherence, use of cocaine, amphetamines, other illicit drugs, sympathomimetics (decongestants, anorectics), oral contraceptive hormones, nonsteroidal anti-inflammatory drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute (InCor)

São Paulo, São Paulo, 05403-904, Brazil

Location

Related Publications (1)

  • Pedrosa RP, Drager LF, de Paula LKG, Amaro ACS, Bortolotto LA, Lorenzi-Filho G. Effects of OSA treatment on BP in patients with resistant hypertension: a randomized trial. Chest. 2013 Nov;144(5):1487-1494. doi: 10.1378/chest.13-0085.

    PMID: 23598607DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHypertension

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD; PhD

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 22, 2008

Study Start

October 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations

BR(1)