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

NCT ID: NCT03936751

Last Updated: 2024-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2022-12-31

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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea Pulmonary Edema Cardiac Cause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CPAP

Continuous positive airway pressure

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

This is the standard treatment for OSA.

Nasal strips

Nasal Strips

Group Type SHAM_COMPARATOR

Nasal Strips

Intervention Type DEVICE

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.

Interventions

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CPAP

This is the standard treatment for OSA.

Intervention Type 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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philips Respironics

INDUSTRY

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Luciano F Drager, MD, PhD

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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PROCAPE - University of Pernambuco

Recife, São Paulo, Brazil

Site Status

Hospital Samaritano

São Paulo, São Paulo, Brazil

Site Status

Heart Institute (InCor)

São Paulo, , Brazil

Site Status

Hospital Dante Pazzanese

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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SDC 4782/18/148

Identifier Type: -

Identifier Source: org_study_id

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