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

NCT03936751 | Terminated Phase 4 FDA Device

• 1 other identifier: SDC 4782/18/148
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

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.

Conditions

Obstructive Sleep Apnea; Pulmonary Edema Cardiac Cause

Outcome Measures

Primary Outcomes (1)

• Rate of ACPE recurrence

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

  1-year

Secondary Outcomes (6)

• Rate of all-cause mortality

  1-year

• Rate of cardiovascular mortality

  1-year

• Number of new hospital admissions

  1-year

• Blood pressure effects ( (mmHg)

  1-year

• Levels of BNP levels (pg/ml)

  1-year

Study Arms (2)

CPAP

ACTIVE COMPARATOR

Continuous positive airway pressure

Device: CPAP

Nasal strips

SHAM COMPARATOR

Nasal Strips

Device: Nasal Strips

Interventions

CPAP DEVICE

This is the standard treatment for OSA.

CPAP

Nasal Strips 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.

Nasal strips

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertensive acute Cardiogenic Pulmonary Edema
• Moderate to Severe OSA

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Philips Respironics: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (4)

PROCAPE - University of Pernambuco

Recife, São Paulo, Brazil

Location

Hospital Samaritano

São Paulo, São Paulo, Brazil

Location

Heart Institute (InCor)

São Paulo, 05049000, Brazil

Location

Hospital Dante Pazzanese

São Paulo, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Heart Failure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: May 3, 2019
• Study Start: April 1, 2019
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (4)