Obstructive Sleep Apnea Treatment on Cardiovascular Events in Patients With Acute Cardiogenic Pulmonary Edema: CPAP-CARE STUDY.

University of Sao Paulo

Status and phase: Terminated; Phase 4

Conditions: Obstructive Sleep Apnea; Pulmonary Edema Cardiac Cause

Treatments: Device: Nasal Strips; Device: CPAP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03936751

SDC 4782/18/148

Details and patient eligibility

About

Despite the advances in the treatment of acute cardiogenic pulmonary edema (ACPE), the readmissions rates and cardiovascular events remain very high. In this context, it is possible that other potential risk factors may influence the poor prognosis of the ACPE. One of these potential candidates is Obstructive Sleep Apnea(OSA). This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with ACPE. The primary outcome will be to evaluate the impact of CPAP on the recurrence of ACPE in the 1-year follow-up.

Enrollment: 150 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypertensive acute Cardiogenic Pulmonary Edema
• Moderate to Severe OSA

Exclusion criteria

• Professional drivers
• Pregnancy
• Non-Cardiogenic Pulmonary edema
• Terminal cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

CPAP

Active Comparator group

Description:

Continuous positive airway pressure

Treatment:

Device: CPAP

Nasal strips

Sham Comparator group

Description:

Nasal Strips

Treatment:

Device: Nasal Strips