Obstructive Sleep ApneaPhase 4CPAP-CARENCT03936751
Obstructive Sleep Apnea Treatment on Cardiovascular Events in Patients With Acute Cardiogenic Pulmonary Edema: CPAP-CARE STUDY.
A Phase 4 study testing CPAP and Nasal Strips in people with Obstructive Sleep Apnea and Pulmonary Edema Cardiac Cause, run by University of Sao Paulo at 4 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Obstructive Sleep Apnea, Pulmonary Edema Cardiac Cause
- What is being tested?
- CPAP and Nasal Strips
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 4 sitesBrazil
- Study dates
- 1 Apr 2019to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensive acute Cardiogenic Pulmonary Edema
- Moderate to Severe OSA
Who cannot join
- Professional drivers
- Pregnancy
- Non-Cardiogenic Pulmonary edema
- Terminal cancer
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
PROCAPE - University of Pernambuco
Recife, São Paulo
Hospital Samaritano
São Paulo, São Paulo
Heart Institute (InCor)
São Paulo, 05049000
Hospital Dante Pazzanese
São Paulo
About this study
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).
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.
- Being tested
- CPAP, Nasal Strips
- Medical subject headings
- Sleep Apnea, Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
This is the standard treatment for OSA.
Nasal StripsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Active comparator | Continuous positive airway pressure Receives: Device: CPAP |
| Nasal strips | Sham comparator | Nasal Strips Receives: Device: Nasal Strips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ACPE recurrence
To evaluate the effects of CPAP on the recurrence of ACPE as compared to placebo
Measured: 1-year
Secondary outcomes (6)
Rate of all-cause mortality
To evaluate the effects of CPAP on the all-cause mortality as compared to placebo
Measured: 1-year
Rate of cardiovascular mortality
To evaluate the effects of CPAP on the cardiovascular mortality as compared to placebo
Measured: 1-year
Number of new hospital admissions
To evaluate the effects of CPAP on the number of new hospital admissions as compared to placebo
Measured: 1-year
Blood pressure effects ( (mmHg)
To evaluate the effects of CPAP on the blood pressure reduction as compared to placebo
Measured: 1-year
Levels of BNP levels (pg/ml)
To evaluate the effects of CPAP on the BNP levels as compared to placebo
Measured: 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
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Apr 2019
- Primary completion31 Jul 2022
- Study completion31 Dec 2022
Why it stopped: COVID-19 pandemic and philips cpap machine recall
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Respironics, Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Luciano F Drager, MD, PhD, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936751
- Sponsor's protocol ID
- SDC 4782/18/148
- Acronym
- CPAP-CARE
- Status last verified
- Jun 2024
- First submitted
- 5 Apr 2019
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT03936751
- Acronym / sponsor ID
- CPAP-CARE / SDC 4782/18/148
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic and philips cpap machine recall
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Philips Respironics, Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Active comparator | Device: CPAPContinuous positive airway pressure |
| Nasal strips | Sham comparator | Device: Nasal StripsNasal Strips |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hypertensive acute Cardiogenic Pulmonary Edema
- Moderate to Severe OSA
Key exclusion criteria (4 listed)
- Professional drivers
- Pregnancy
- Non-Cardiogenic Pulmonary edema
- Terminal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPThis is the standard treatment for OSA. | Device | CPAP |
| Nasal StripsNasal 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. | Device | Nasal strips |
Primary outcome
Rate of ACPE recurrence
Time frame: 1-year
To evaluate the effects of CPAP on the recurrence of ACPE as compared to placebo
6 secondary outcomes
Rate of all-cause mortality
Time frame: 1-year
Rate of cardiovascular mortality
Time frame: 1-year
Number of new hospital admissions
Time frame: 1-year
Blood pressure effects ( (mmHg)
Time frame: 1-year
Levels of BNP levels (pg/ml)
Time frame: 1-year
Cardiac function (left ventricular ejection fraction - %)
Time frame: 1-year
Results and safety
The study was stopped early (reason given: COVID-19 pandemic and philips cpap machine recall). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CPAP and Nasal Strips in people with Obstructive Sleep Apnea and Pulmonary Edema Cardiac Cause, run by University of Sao Paulo at 4 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: COVID-19 pandemic and philips cpap machine recall). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ACPE recurrence (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.