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

Phase 4TerminatedNCT03936751

University of Sao Paulo150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Obstructive Sleep Apnea Pulmonary Edema Cardiac Cause

Interventions

This is the standard treatment for OSA.

Nasal StripsDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hypertensive acute Cardiogenic Pulmonary Edema * Moderate to Severe OSA Exclusion Criteria: * Professional drivers * Pregnancy * Non-Cardiogenic Pulmonary edema * Terminal cancer

Locations (4)

PROCAPE - University of Pernambuco

Recife, São Paulo, Brazil

Hospital Samaritano

São Paulo, São Paulo, Brazil

Heart Institute (InCor)

São Paulo, Brazil

Hospital Dante Pazzanese

São Paulo, Brazil

Outcomes

Primary Outcomes

Rate of ACPE recurrence

To evaluate the effects of CPAP on the recurrence of ACPE as compared to placebo

Time frame: 1-year

Secondary Outcomes

Rate of all-cause mortality

To evaluate the effects of CPAP on the all-cause mortality as compared to placebo

Time frame: 1-year

Rate of cardiovascular mortality

To evaluate the effects of CPAP on the cardiovascular mortality as compared to placebo

Time frame: 1-year

Number of new hospital admissions

To evaluate the effects of CPAP on the number of new hospital admissions as compared to placebo

Time frame: 1-year

Blood pressure effects ( (mmHg)

To evaluate the effects of CPAP on the blood pressure reduction as compared to placebo

Time frame: 1-year

Levels of BNP levels (pg/ml)

To evaluate the effects of CPAP on the BNP levels as compared to placebo

Time frame: 1-year

Cardiac function (left ventricular ejection fraction - %)

To evaluate the effects of CPAP on the left ventricular ejection fraction (by echocardiography) as compared to placebo

Time frame: 1-year

Data from ClinicalTrials.gov

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