Morbidity in Patients With Hypertension and Obstructive Sleep Apnea

Hypertension Clinical Trial

— MORPHEOS  

Official title:

Morbidity in Patients With Hypertension and Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270658
• Other study ID #: 3230/08/146
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2020

Study information

• Verified date: September 2023
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Apnea
• Hypertension
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas de Porto Alegre	Porto Alegre	RS
Brazil	Pronto Socorro Cardiológico de Pernambuco (PROCAPE)	Recife	PE
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto	Ribeirão Preto	SP
Brazil	Fundação Zerbini - Instituto do Coração (InCor)	São Paulo	SP
Brazil	Hospital Universitário da Universidade de São Paulo (HU)	São Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Financiadora de Estudos e Projetos

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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 airwa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of OSA treatment with CPAP on office, 24-hour, and central blood pressure (co-primary endpoints).		6 months
Secondary	Impact of OSA treatment with CPAP on target-organ damage		6 months
Secondary	Impact of OSA treatment with CPAP on vascular parameters (to be published as a sub-study)	Pulse wave velocity and carotid intima-media thickness	6 months
Secondary	Impact of OSA treatment with CPAP on hypertensive retinopathy and optic nerve damage (to be published as a sub-study)		6 months
Secondary	Validation of portable sleep monitoring to diagnose OSA (to be published as a sub-study)		6 months