Clinical trial NCT02270658: Morbidity in Patients With Hypertension and Obstructive Sleep Apnea
Official title: Morbidity in Patients With Hypertension and Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Sleep Apnea, Obstructive
Keywords: continuous positive airway pressure
hypertension
sleep apnea
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Financiadora de Estudos e Projetos
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2014-10-21
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: MORPHEOS is a multicenter, randomized, unblinded study, for patients diagnosed with uncontrolled hypertension and at least one antihypertensive medication. Those patients with significant sleep apnea wil be randomized to CPAP or nasal strips for 6 months.


Eligibility criteria: Inclusion Criteria:

* Systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥ 90 mm Hg
* Current treatment with at least 1 antihypertensive drug

Exclusion Criteria:

* Age \<18 and \>65 years
* BMI ≥ 40 kg/m2
* Heart failure, EF \< 45%, acute myocardial infarction, stroke, significant valvular dysfunction
* Chronic renal failure (serum creatinine \> 2 mg/dL)
* Use of cocaine, amphetamines, alcohol, illicit drugs
* Use of sympathomimetics (decongestants, appetite suppressants)
* Use of oral contraceptives and chronic use of NSAIDs
* Pregnancy
* Secondary causes of hypertension (other than sleep apnea)

Primary outcomes:
measure: Impact of OSA treatment with CPAP on office, 24-hour, and central blood pressure (co-primary endpoints).
timeFrame: 6 months
Secondary outcomes:
measure: Impact of OSA treatment with CPAP on target-organ damage
timeFrame: 6 months
measure: Impact of OSA treatment with CPAP on vascular parameters (to be published as a sub-study)
timeFrame: 6 months
measure: Impact of OSA treatment with CPAP on hypertensive retinopathy and optic nerve damage (to be published as a sub-study)
timeFrame: 6 months
measure: Validation of portable sleep monitoring to diagnose OSA (to be published as a sub-study)
timeFrame: 6 months
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Pronto Socorro Cardiológico de Pernambuco (PROCAPE)
state: PE
city: Porto Alegre
country: Brazil
facility: Hospital das Clínicas de Porto Alegre
state: RS
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
state: SP
city: São Paulo
country: Brazil
facility: Fundação Zerbini - Instituto do Coração (InCor)
state: SP
city: São Paulo
country: Brazil
facility: Hospital Universitário da Universidade de São Paulo (HU)
state: SP
Study officials:
affiliation: Fundação Zerbini - Instituto do Coração (InCor)
name: Geraldo Lorenzi, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cruz FCSG, Drager LF, Queiroz DBC, Souza GA, Pedrosa RP, Patriota TLGC, Dorea EL, Vieira MLC, Righi CG, Martinez D, Silva GAD, Silva GV, Pio-Abreu A, Lotufo PA, Benseaor IM, Bortolotto LA, Fuchs FD, Lorenzi-Filho G. The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic. Clinics (Sao Paulo). 2021 Sep 3;76:e2926. doi: 10.6061/clinics/2021/e2926. eCollection 2021.