Obstructive Sleep Apnea, Pulmonary Edema Cardiac Cause
Conditions
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.
Interventions
DEVICECPAP
This is the standard treatment for OSA.
DEVICENasal 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.
Sponsors
Philips Respironics
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Hypertensive acute Cardiogenic Pulmonary Edema * Moderate to Severe OSA
Exclusion criteria
* Professional drivers * Pregnancy * Non-Cardiogenic Pulmonary edema * Terminal cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of ACPE recurrence | 1-year | To evaluate the effects of CPAP on the recurrence of ACPE as compared to placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Blood pressure effects ( (mmHg) | 1-year | To evaluate the effects of CPAP on the blood pressure reduction as compared to placebo |
Countries
Brazil
Outcome results
None listed