Efficacy of CPAP Treatment on Blood Pressure of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome

NCT ID: NCT01508754

Last Updated: 2014-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-08-31

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).

Detailed Description

Obstructive sleep apnea syndromes (OSAS) have been demonstrated to be highly prevalent in patients with resistant hypertension (defined as uncontrolled clinic BP despite being on anti-hypertensive treatment with at least 3 drugs in optimal doses and including a diuretic). Nevertheless, the effect of treating OSAS with Continuous Positive Airway Pressure (CPAP) device on clinic and ambulatory BPs in patients with resistant hypertension is largely unknown. Hence, the primary aim of this randomized clinical trial is to evaluate the effect of CPAP on BP levels in resistant hypertensive patients with moderate-severe OSAS (defined as an apnea-hypopnea index [AHI] greater than 15 on a full polysomnographic examination). Two-hundred patients will be randomly allocated either to treatment with CPAP device plus their usual anti-hypertensive treatment or to continue their usual treatment alone for 6 months. Clinic and 24-hour ambulatory BP monitoring, laboratory evaluation (including microalbuminuria and aldosterone-to-renin ratio), 24-hour Holter monitoring, ergospirometric treadmill test, and carotid-femoral pulse wave velocity measurement will be performed before and after the 6-month treatment, with the observers blinded to the allocation group.

Conditions

Obstructive Sleep Apnea Syndrome; Resistant Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CPAP

Treatment with Continuous Positive Airway Pressure

Group Type: ACTIVE_COMPARATOR

Continuous positive airway pressure treatment

Intervention Type: PROCEDURE

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

Control

Usual anti-hypertensive treatment without CPAP treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Continuous positive airway pressure treatment

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Financiadora de Estudos e Projetos

OTHER

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Gil Fernando da Costa Mendes de Salles, PhD

Full Professor, Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gil F Salles, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Program of Arterial Hypertension, University Hospital Clementino Fraga Filho

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 14732721 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11725173 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11560187 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17393240 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17452537 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21106625 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20577130 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32048379 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28129246 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25601933 (View on PubMed)

Related Links

http://www.prohart.hucff.ufrj.br

Related Info

Other Identifiers

FINEP-01.08.0615.00

Identifier Type: -

Identifier Source: org_study_id