Cardiogenic Pulmonary EdemaCAPENCT06107257
Cardiogenic Acute Pulmonary Edema in Subjects Over 75 Years Old: Impact of Non-invasive Ventilation on Mortality
An observational study of Cardiogenic Pulmonary Edema, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
People aged over 75 represent almost 10% of the general population, and 12 to 14% of patients consulting emergency departments. Cardiogenic acute pulmonary edema (APO) is a very common reason for admission to the emergency room. Read more about this study
- Who is it for?
- Ages 76 years and older
- Conditions the study is for
- Cardiogenic Pulmonary Edema
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to 31 Dec 2023
- Phase
- Observational
- 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 76 years and older
- All sexes
- Older adult
Study population: Adult subject (> 75 years) with a diagnosis of cardiogenic PAO treated at Strasbourg University Hospital between January 1, 2021 and October 31, 2021
Who may be able to join
- Adult subject (> 75 years old)
- Admission to the NHC emergency room between January 1, 2021 and October 31, 2021
- Diagnosis of cardiogenic PAO
- Indication of NIV according to current recommendations
- Subject not opposing the reuse of their data for scientific research purposes.
Who cannot join
- Subject having expressed his opposition to the reuse of his data for scientific research purposes.
- Presence of an absolute contraindication to NIV
- Respiratory distress due to pneumonia or other diagnosis
- RT-PCR Sars Cov 2 positive in emergency
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Gériatrie - Service de Soins de Soins Médicaux et de Réadaptation - CHU de Strasbourg - France
Strasbourg, 67091
Elise SCHMITT, MD, 33 3 88 11 58 84, elise.schmitt@chru-strasbourg.fr
Linda HADDI, MD, 33 3 88 11 58 84, linda.haddi@chru-strasbourg.fr
About this study
People aged over 75 represent almost 10% of the general population, and 12 to 14% of patients consulting emergency departments. Cardiogenic acute pulmonary edema (APO) is a very common reason for admission to the emergency room. The effectiveness of non-invasive ventilation (NIV) has been demonstrated during the management of PAO and would allow, compared to medical treatment alone, a more rapid improvement in clinical and gasometric parameters as well as a reduction in the need for ventilation. orotracheal intubation. On the other hand, the impact of NIV on mortality in cardiogenic PAO seems poorly defined, with lower levels of scientific evidence regarding a possible benefit in terms of survival, particularly in the elderly population.
The objective of this study is to determine whether the use of NIV in cardiogenic PAO in elderly subjects admitted to the emergency room of Strasbourg University Hospital would have an impact in terms of mortality up to 6 months compared to medical treatment alone.
- Conditions
- Cardiogenic Pulmonary Edema
- Keywords
- Cardiogenic Pulmonary Edema, Acute pulmonary edema, Non-invasive ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Analysis
Measured: 6 months after cardiogenic acute pulmonary edema
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Feb 2023
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic Pulmonary EdemaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107257
- Sponsor's protocol ID
- 8785
- Acronym
- CAPE
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Haddi L, Valerio L, Bilbault P, Kaltenbach G, Schmitt E. Effect of noninvasive ventilation on 6-month mortality in patients with acute cardiogenic pulmonary oedema: a retrospective study dedicated to older persons. Intern Emerg Med. 2025 Sep;20(6):1753-1760. doi: 10.1007/s11739-025-04012-3. Epub 2025 Jun 15.
PubMed 40517332
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiogenic Acute Pulmonary Edema in Subjects Over 75 Years Old: Impact of Non-invasive Ventilation on Mortality
- ClinicalTrials.gov ID
- NCT06107257
- Acronym / sponsor ID
- CAPE / 8785
- Conditions
- Cardiogenic Pulmonary Edema
- Keywords
- Cardiogenic Pulmonary Edema, Acute pulmonary edema, Non-invasive ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Oct 2023 (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.
People aged over 75 represent almost 10% of the general population, and 12 to 14% of patients consulting emergency departments. Cardiogenic acute pulmonary edema (APO) is a very common reason for admission to the emergency room. The effectiveness of non-invasive ventilation (NIV) has been demonstrated during the management of PAO and would allow, compared to medical treatment alone, a more rapid improvement in clinical and gasometric parameters as well as a reduction in the need for ventilation. orotracheal intubation. On the other hand, the impact of NIV on mortality in cardiogenic PAO seems poorly defined, with lower levels of scientific evidence regarding a possible benefit in terms of survival, particularly in the elderly population.
The objective of this study is to determine whether the use of NIV in cardiogenic PAO in elderly subjects admitted to the emergency room of Strasbourg University Hospital would have an impact in terms of mortality up to 6 months compared to medical treatment alone.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Adult subject (> 75 years) with a diagnosis of cardiogenic PAO treated at Strasbourg University Hospital between January 1, 2021 and October 31, 2021
Key inclusion criteria (5 listed)
- Adult subject (> 75 years old)
- Admission to the NHC emergency room between January 1, 2021 and October 31, 2021
- Diagnosis of cardiogenic PAO
- Indication of NIV according to current recommendations
- Subject not opposing the reuse of their data for scientific research purposes.
Key exclusion criteria (4 listed)
- Subject having expressed his opposition to the reuse of his data for scientific research purposes.
- Presence of an absolute contraindication to NIV
- Respiratory distress due to pneumonia or other diagnosis
- RT-PCR Sars Cov 2 positive in emergency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival Analysis
Time frame: 6 months after cardiogenic acute pulmonary edema
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Derived from this study: PubMed 40517332Haddi L, Valerio L, Bilbault P, Kaltenbach G, Schmitt E. Effect of noninvasive ventilation on 6-month mortality in patients with acute cardiogenic pulmonary oedema: a retrospective study dedicated to older persons. Intern Emerg Med. 2025 Sep;20(6):1753-1760. doi: 10.1007/s11739-025-04012-3. Epub 2025 Jun 15.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Pulmonary Edema, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 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: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elise SCHMITT, MD (33 3 88 11 58 84, elise.schmitt@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Analysis (time frame: 6 months after cardiogenic acute pulmonary edema). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06107257, which also lists 1 linked publication.
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 30 Oct 2023.