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

Obstructive Sleep Apnea Clinical Trial

— 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).

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03936751
• Other study ID #: SDC 4782/18/148
• Status: Suspended
• Phase: Phase 4
• Start date: April 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2022
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 150
• Est. completion date: December 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Hypertensive acute Cardiogenic Pulmonary Edema
• Moderate to Severe OSA

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Apnea
• Edema
• Obstructive Sleep Apnea
• Pulmonary Edema
• Pulmonary Edema Cardiac Cause
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
This is the standard treatment for OSA.
• 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.

Locations

Country	Name	City	State
Brazil	PROCAPE - University of Pernambuco	Recife	Sao Paulo
Brazil	Heart Institute (InCor)	Sao Paulo
Brazil	Hospital Dante Pazzanese	Sao Paulo
Brazil	Hospital Samaritano	Sao Paulo	SP

Sponsors (4)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo, Philips Respironics

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of ACPE recurrence	To evaluate the effects of CPAP on the recurrence of ACPE as compared to placebo	1-year
Secondary	Rate of all-cause mortality	To evaluate the effects of CPAP on the all-cause mortality as compared to placebo	1-year
Secondary	Rate of cardiovascular mortality	To evaluate the effects of CPAP on the cardiovascular mortality as compared to placebo	1-year
Secondary	Number of new hospital admissions	To evaluate the effects of CPAP on the number of new hospital admissions as compared to placebo	1-year
Secondary	Blood pressure effects ( (mmHg)	To evaluate the effects of CPAP on the blood pressure reduction as compared to placebo	1-year
Secondary	Levels of BNP levels (pg/ml)	To evaluate the effects of CPAP on the BNP levels as compared to placebo	1-year
Secondary	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