Back to resultsObstructive Sleep Apnea Treatment on Cardiovascular Events in Patients With Acute Cardiogenic Pulmonary Edema: CPAP-CARE STUDY. (CPAP-CARE)
Primary Purpose
Obstructive Sleep Apnea, Pulmonary Edema Cardiac Cause
Status
Suspended
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
CPAP
Nasal Strips
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Hypertensive acute Cardiogenic Pulmonary Edema
- Moderate to Severe OSA
Exclusion Criteria:
- Professional drivers
- Pregnancy
- Non-Cardiogenic Pulmonary edema
- Terminal cancer
Sites / Locations
- PROCAPE - University of Pernambuco
- Hospital Samaritano
- Heart Institute (InCor)
- Hospital Dante Pazzanese
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
CPAP
Nasal strips
Arm Description
Continuous positive airway pressure
Nasal Strips
Outcomes
Primary Outcome Measures
Rate of ACPE recurrence
To evaluate the effects of CPAP on the recurrence of ACPE as compared to placebo
Secondary Outcome Measures
Rate of all-cause mortality
To evaluate the effects of CPAP on the all-cause mortality as compared to placebo
Rate of cardiovascular mortality
To evaluate the effects of CPAP on the cardiovascular mortality as compared to placebo
Number of new hospital admissions
To evaluate the effects of CPAP on the number of new hospital admissions as compared to placebo
Blood pressure effects ( (mmHg)
To evaluate the effects of CPAP on the blood pressure reduction as compared to placebo
Levels of BNP levels (pg/ml)
To evaluate the effects of CPAP on the BNP levels as compared to placebo
Cardiac function (left ventricular ejection fraction - %)
To evaluate the effects of CPAP on the left ventricular ejection fraction (by echocardiography) as compared to placebo
Full Information
NCT ID
NCT03936751
First Posted
April 5, 2019
Last Updated
December 27, 2022
Sponsor
University of Sao Paulo
Collaborators
Philips Respironics, Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT03936751
Brief Title
Obstructive Sleep Apnea Treatment on Cardiovascular Events in Patients With Acute Cardiogenic Pulmonary Edema: CPAP-CARE STUDY.
Acronym
CPAP-CARE
Official Title
Impact of Obstructive Sleep Apnea Treatment on Cardiovascular Events in Patients With Acute Cardiogenic Pulmonary Edema: a Multicenter Randomized Controlled Study (CPAP-CARE STUDY).
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Suspended
Why Stopped
COVID-19 pandemic and philips cpap machine recall
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Philips Respironics, Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Pulmonary Edema Cardiac Cause
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CPAP
Arm Type
Active Comparator
Arm Description
Continuous positive airway pressure
Arm Title
Nasal strips
Arm Type
Sham Comparator
Arm Description
Nasal Strips
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
This is the standard treatment for OSA.
Intervention Type
Device
Intervention Name(s)
Nasal Strips
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of ACPE recurrence
Description
To evaluate the effects of CPAP on the recurrence of ACPE as compared to placebo
Time Frame
1-year
Secondary Outcome Measure Information:
Title
Rate of all-cause mortality
Description
To evaluate the effects of CPAP on the all-cause mortality as compared to placebo
Time Frame
1-year
Title
Rate of cardiovascular mortality
Description
To evaluate the effects of CPAP on the cardiovascular mortality as compared to placebo
Time Frame
1-year
Title
Number of new hospital admissions
Description
To evaluate the effects of CPAP on the number of new hospital admissions as compared to placebo
Time Frame
1-year
Title
Blood pressure effects ( (mmHg)
Description
To evaluate the effects of CPAP on the blood pressure reduction as compared to placebo
Time Frame
1-year
Title
Levels of BNP levels (pg/ml)
Description
To evaluate the effects of CPAP on the BNP levels as compared to placebo
Time Frame
1-year
Title
Cardiac function (left ventricular ejection fraction - %)
Description
To evaluate the effects of CPAP on the left ventricular ejection fraction (by echocardiography) as compared to placebo
Time Frame
1-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hypertensive acute Cardiogenic Pulmonary Edema
Moderate to Severe OSA
Exclusion Criteria:
Professional drivers
Pregnancy
Non-Cardiogenic Pulmonary edema
Terminal cancer
Facility Information:
Facility Name
PROCAPE - University of Pernambuco
City
Recife
State/Province
Sao Paulo
Country
Brazil
Facility Name
Hospital Samaritano
City
Sao Paulo
State/Province
SP
Country
Brazil
Facility Name
Heart Institute (InCor)
City
Sao Paulo
ZIP/Postal Code
05049000
Country
Brazil
Facility Name
Hospital Dante Pazzanese
City
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Obstructive Sleep Apnea Treatment on Cardiovascular Events in Patients With Acute Cardiogenic Pulmonary Edema: CPAP-CARE STUDY.
We'll reach out to this number within 24 hrs