NCT03936751

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

Impact of Obstructive Sleep Apnea Treatment on Cardiovascular Events in Patients With Acute Cardiogenic Pulmonary Edema: a Multicenter Randomized Controlled Study (CPAP-CARE STUDY).

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Obstructive Sleep Apnea
• Pulmonary Edema Cardiac Cause

Interventions

Type	Name	Description
DEVICE	CPAP	This is the standard treatment for OSA.
DEVICE	Nasal Strips	Nasal strips were commercially available in the market for supposing treat snoring and sleep apnea but no proof that this is true. Our group previously validated nasal strips as an interesting placebo.

Timeline

• Start date: 2019-04-01
• Primary completion: 2022-07-31
• Completion: 2022-12-31
• First posted: 2019-05-03
• Last updated: 2024-06-07

Locations

4 sites across 1 country: Brazil

Regulatory

• FDA-regulated device study