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

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

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 Overview

• Status: Suspended
• Conditions: Obstructive Sleep Apnea; Pulmonary Edema Cardiac Cause
• Intervention / Treatment: Device: CPAP; Device: Nasal Strips

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05049000
    • Heart Institute (InCor)
  • Sao Paulo, Brazil
    • Hospital Dante Pazzanese
  • SP
    • Sao Paulo, SP, Brazil
      • Hospital Samaritano
  • Sao Paulo
    • Recife, Sao Paulo, Brazil
      • PROCAPE - University of Pernambuco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hypertensive acute Cardiogenic Pulmonary Edema
• Moderate to Severe OSA

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CPAP; Continuous positive airway pressure	Device: CPAP; This is the standard treatment for OSA.
Sham Comparator: Nasal strips; Nasal Strips	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.

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): July 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 27, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Edema; Pulmonary Edema
• Other Study ID Numbers: SDC 4782/18/148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes