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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obstructive Sleep Apnea, Pulmonary Edema Cardiac Cause

Intervention / Treatment
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* Device: CPAP
* Device: Nasal Strips


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPAP<br>Continuous positive airway pressure | Device: CPAP<br>* This is the standard treatment for OSA.<br>|
| Sham Comparator: Nasal strips<br>Nasal Strips | Device: Nasal Strips<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ACPE recurrence | To evaluate the effects of CPAP on the recurrence of ACPE as compared to placebo | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all-cause mortality | To evaluate the effects of CPAP on the all-cause mortality as compared to placebo | 1-year | 
| Rate of cardiovascular mortality | To evaluate the effects of CPAP on the cardiovascular mortality as compared to placebo | 1-year | 
| Number of new hospital admissions | To evaluate the effects of CPAP on the number of new hospital admissions as compared to placebo | 1-year | 
| Blood pressure effects ( (mmHg) | To evaluate the effects of CPAP on the blood pressure reduction as compared to placebo | 1-year | 
| Levels of BNP levels (pg/ml) | To evaluate the effects of CPAP on the BNP levels as compared to placebo | 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 | 1-year |