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

Phase 4

Terminated

• Conditions: Obstructive Sleep Apnea; Pulmonary Edema Cardiac Cause
• Interventions: Device: CPAP; Device: Nasal Strips

• Registration Number: NCT03936751
• Lead Sponsor: University of Sao Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-03
• Primary Completion: 2022-07-31
• Study Completion: 2022-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Hypertensive acute Cardiogenic Pulmonary Edema
• Moderate to Severe OSA

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP	CPAP	Continuous positive airway pressure
Nasal strips	Nasal Strips	Nasal Strips

Primary Outcome Measures

Name	Time	Method
Rate of ACPE recurrence	1-year	To evaluate the effects of CPAP on the recurrence of ACPE as compared to placebo

Secondary Outcome Measures

Name	Time	Method
Rate of cardiovascular mortality	1-year	To evaluate the effects of CPAP on the cardiovascular mortality as compared to placebo
Number of new hospital admissions	1-year	To evaluate the effects of CPAP on the number of new hospital admissions as compared to placebo
Blood pressure effects ( (mmHg)	1-year	To evaluate the effects of CPAP on the blood pressure reduction as compared to placebo
Rate of all-cause mortality	1-year	To evaluate the effects of CPAP on the all-cause mortality as compared to placebo
Levels of BNP levels (pg/ml)	1-year	To evaluate the effects of CPAP on the BNP levels as compared to placebo
Cardiac function (left ventricular ejection fraction - %)	1-year	To evaluate the effects of CPAP on the left ventricular ejection fraction (by echocardiography) as compared to placebo

Trial Locations

Locations (4)

Heart Institute (InCor); 🇧🇷 Sao Paulo, Brazil

PROCAPE - University of Pernambuco; 🇧🇷 Recife, Sao Paulo, Brazil

Hospital Samaritano; 🇧🇷 Sao Paulo, SP, Brazil

Hospital Dante Pazzanese; 🇧🇷 Sao Paulo, Brazil