NCT01508754

Brief Summary

The aim is to evaluate the effect of treatment with Continuous Positive Airway Pressure (CPAP) device on clinic and ambulatory blood pressures (BP) of 200 resistant hypertensive patients with moderate-severe obstructive sleep apnea syndrome (OSAS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2012

Typical duration for phase_4

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

Study Start

First participant enrolled

January 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 15, 2014

Status Verified

September 1, 2014

Enrollment Period

2.6 years

First QC Date

January 5, 2012

Last Update Submit

September 12, 2014

Conditions

Obstructive Sleep Apnea SyndromeResistant Hypertension

Keywords

Continuous positive airway pressureAmbulatory blood pressures

Outcome Measures

Primary Outcomes (1)

  • clinic and ambulatory blood pressures

    Clinic and ambulatory blood pressures (during 24-hour ambulatory blood pressure monitoring, which included both daytime and nighttime blood pressures, as well as the nocturnal dipping pattern).

    6 months

Secondary Outcomes (5)

  • Microalbuminuria

    6 months

  • Aldosterone excess measurements

    6 months

  • Arterial stiffness

    6 months

  • Autonomic system measurements

    6 months

  • Cardiorespiratory fitness

    6 months

Study Arms (2)

CPAP

ACTIVE COMPARATOR

Treatment with Continuous Positive Airway Pressure

Procedure: Continuous positive airway pressure treatment

Control

NO INTERVENTION

Usual anti-hypertensive treatment without CPAP treatment

Interventions

Continuous positive airway pressure treatmentPROCEDURE

Treatment with CPAP for 6 months, pressure will be titrated during a second polysomnography.

CPAP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with resistant hypertension and moderate-severe obstructive sleep apnea syndrome

You may not qualify if:

  • Older than 80 years
  • Pregnant women
  • Non-adherent to anti-hypertensive treatment
  • Severe cognitive deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Program of Arterial Hypertension, University Hospital Clementino Fraga Filho

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

Related Publications (10)

  • Goodfriend TL, Calhoun DA. Resistant hypertension, obesity, sleep apnea, and aldosterone: theory and therapy. Hypertension. 2004 Mar;43(3):518-24. doi: 10.1161/01.HYP.0000116223.97436.e5. Epub 2004 Jan 19.

    PMID: 14732721BACKGROUND

  • Logan AG, Perlikowski SM, Mente A, Tisler A, Tkacova R, Niroumand M, Leung RS, Bradley TD. High prevalence of unrecognized sleep apnoea in drug-resistant hypertension. J Hypertens. 2001 Dec;19(12):2271-7. doi: 10.1097/00004872-200112000-00022.

    PMID: 11725173BACKGROUND

  • Lavie P, Hoffstein V. Sleep apnea syndrome: a possible contributing factor to resistant. Sleep. 2001 Sep 15;24(6):721-5. doi: 10.1093/sleep/24.6.721.

    PMID: 11560187BACKGROUND

  • Alajmi M, Mulgrew AT, Fox J, Davidson W, Schulzer M, Mak E, Ryan CF, Fleetham J, Choi P, Ayas NT. Impact of continuous positive airway pressure therapy on blood pressure in patients with obstructive sleep apnea hypopnea: a meta-analysis of randomized controlled trials. Lung. 2007 Mar-Apr;185(2):67-72. doi: 10.1007/s00408-006-0117-x. Epub 2007 Mar 28.

    PMID: 17393240BACKGROUND

  • Haentjens P, Van Meerhaeghe A, Moscariello A, De Weerdt S, Poppe K, Dupont A, Velkeniers B. The impact of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea syndrome: evidence from a meta-analysis of placebo-controlled randomized trials. Arch Intern Med. 2007 Apr 23;167(8):757-64. doi: 10.1001/archinte.167.8.757.

    PMID: 17452537BACKGROUND

  • Duran-Cantolla J, Aizpuru F, Montserrat JM, Ballester E, Teran-Santos J, Aguirregomoscorta JI, Gonzalez M, Lloberes P, Masa JF, De La Pena M, Carrizo S, Mayos M, Barbe F; Spanish Sleep and Breathing Group. Continuous positive airway pressure as treatment for systemic hypertension in people with obstructive sleep apnoea: randomised controlled trial. BMJ. 2010 Nov 24;341:c5991. doi: 10.1136/bmj.c5991.

    PMID: 21106625BACKGROUND

  • Lozano L, Tovar JL, Sampol G, Romero O, Jurado MJ, Segarra A, Espinel E, Rios J, Untoria MD, Lloberes P. Continuous positive airway pressure treatment in sleep apnea patients with resistant hypertension: a randomized, controlled trial. J Hypertens. 2010 Oct;28(10):2161-8. doi: 10.1097/HJH.0b013e32833b9c63.

    PMID: 20577130BACKGROUND

  • Cardoso CRL, Roderjan CN, Cavalcanti AH, Cortez AF, Muxfeldt ES, Salles GF. Effects of continuous positive airway pressure treatment on aortic stiffness in patients with resistant hypertension and obstructive sleep apnea: A randomized controlled trial. J Sleep Res. 2020 Aug;29(4):e12990. doi: 10.1111/jsr.12990. Epub 2020 Feb 12.

    PMID: 32048379DERIVED

  • de Souza F, Muxfeldt ES, Margallo V, Cortez AF, Cavalcanti AH, Salles GF. Effects of continuous positive airway pressure treatment on aldosterone excretion in patients with obstructive sleep apnoea and resistant hypertension: a randomized controlled trial. J Hypertens. 2017 Apr;35(4):837-844. doi: 10.1097/HJH.0000000000001254.

    PMID: 28129246DERIVED

  • Muxfeldt ES, Margallo V, Costa LM, Guimaraes G, Cavalcante AH, Azevedo JC, de Souza F, Cardoso CR, Salles GF. Effects of continuous positive airway pressure treatment on clinic and ambulatory blood pressures in patients with obstructive sleep apnea and resistant hypertension: a randomized controlled trial. Hypertension. 2015 Apr;65(4):736-42. doi: 10.1161/HYPERTENSIONAHA.114.04852. Epub 2015 Jan 19.

    PMID: 25601933DERIVED

Related Links

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gil F Salles, PhD

    Department of Internal Medicine, Faculty of Medicine, federal University of Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor, Faculty of Medicine

Study Record Dates

First Submitted

January 5, 2012

First Posted

January 12, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 15, 2014

Record last verified: 2014-09

Locations

BR(1)