Dyspnea, ParoxysmalRENAU-OAPNCT03148847
Management of Cardiogenic Pulmonary Edema (RENAU-OAP)
An observational study of Dyspnea, Paroxysmal and Heart Failure, Left Sided, run by Centre Hospitalier Annecy Genevois at 1 site in France.
Trial summary
The prevalence of heart failure is estimated to 2.3 percent of the adult population and strongly increases with age, according to french disability-health surveys. In France, more than 32,000 annual deaths are attributable to heart failure and the five-year survival rate is similar to those found in many cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Paroxysmal, Heart Failure, Left Sided
- What is being tested?
- Baseline care and Referential's dissemination
- How many people
- 859 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jan 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: As the goal of this study is to analyze common practices, data from the french medicalized information system program will be used to select a study population as exhaustive as possible. This program is dedicated to systematic collection of data from hospital stays. Each hospital stay is identified by a unique number and a diagnosis is attributed for each, at the end of every hospital stay. Diagnosis are based on the International Classification of Diseases (ICD-10). At hospital levels, a unique stay number can be related to names and addresses of involved patients. French medicalized information system program data are analyzed at a regional and then a national level. For this study, cases will be screened if they had a I500, I501 and I509 ICD-10 diagnosis (main or associated).
Who may be able to join
- ≥18 years old
- hospitalization during one of the two designed period (either year 2013, or year 2017) in a center belonging to Northern French Alps Emergency Network
- diagnosis of cardiogenic pulmonary edema, or heart failure (either left-sided, congestive or unspecified)
Who cannot join
- people who refuse to have their health information used will not be included
- people whose care will have begun in a center not belonging to the Northern French Alps Emergency Network
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Professional Practices on the Management of Cardiogenic Pulmonary Edema (RENAU-OAP)
The prevalence of heart failure is estimated to 2.3 percent of the adult population and strongly increases with age, according to french disability-health surveys. In France, more than 32,000 annual deaths are attributable to heart failure and the five-year survival rate is similar to those found in many cancers. A better therapeutic management (angiotensin converting enzyme inhibitor and beta-blockers) helped reduce mortality after an episode of heart failure requiring hospitalization, but, nevertheless it remains high.
The severity of cardiogenic pulmonary edema depends on several factors such as etiology, hemodynamic status, effect on hematosis, and fatigue.
Read more
It is important to note that cardiogenic pulmonary edema initial management is decisive. In addition, early and adapted management of cardiogenic pulmonary edema is associated with a shorter hospital stay and reduced hospital mortality.
The Coronary Emergency Network (RESURCOR) within the Northern French Alps Emergency Network (RENAU) is an emergency care system structured in the departments of Isère, Savoie and Haute Savoie. Its main goal is to help improve emergency management by using regional good practice guidelines (www.renau.org). In this context, projects aiming to evaluate professional practices are developed regularly. Since emergency management of cardiogenic pulmonary edema has not been evaluated, the Northern French Alps Emergency Network offers an approach to improve professional practices by defining and disseminating guidelines on cardiogenic pulmonary edema management which will then be assessed.
Read the detailed description
The prevalence of heart failure is estimated to 2.3 percent of the adult population and strongly increases with age, according to disability-health surveys in France. In recent years, effective treatments (revascularization in percutaneous coronary intervention, circulatory assistance) helped reduce mortality in post-myocardial infarction, which combined with the increase of life expectancy has led to an increase number of patients with chronic heart failure. More than 32,000 annual deaths are attributable to heart failure and the five-year survival rate is similar to those found in cancers of the breast, bladder, colon, ovarian, and prostate. A better therapeutic management (angiotensin converting enzyme inhibitor and beta-blockers) helped reduce mortality after an episode of heart failure requiring hospitalization, but, nevertheless it remains high.
Main clinical manifestations are those of left heart failure, such as cardiogenic pulmonary edema which is a medical emergency. Treatment must take into account pathophysiological aspects of heart failure, etiologies of cardiogenic pulmonary edema and any potential factors or triggers apart from general measures. Two consensus statements and an international recommendation help define therapeutic strategies in this particular situation.
Signs suggestive of cardiogenic pulmonary edema include orthopnea, bilateral crackles or wheezing (patients over 70 years without known asthma), edema of the lower limbs, and gallop sound on heart auscultation. The evolution of these signs makes it particularly possible to manage the response to the treatment. The severity of cardiogenic pulmonary edema depends on several factors such as etiology (ECG analysis and chest pain assessment for acute coronary syndrome), hemodynamic status (blood pressure, heart rate), effect on hematosis (cyanosis, oxygen saturation), and fatigue (low respiratory rate with persistent cardiogenic pulmonary edema signs). The respiratory rate represents a simple clinical feature that can be used to quantify dyspnea (sign of severity if greater than 30 per minute in adults) and then follow its evolution (improvement, exhaustion). Disorders of consciousness can testify to the severity of the hemodynamic state and/or exhaustion.
Cardiogenic pulmonary edema management without shock implies urgent administration of vasodilators (trinitrin) and intravenous loop diuretics in presence of congestion signs along with the establishment of a system of care adapted to severity (Emergency Mobile Services or ambulance, hospitalization in Intensive Care Unit, intensive cardiology unit, cardiology or medicine department, or emergency passage). The subsequent therapeutic management will especially depend on initial treatment by the primary care physician, so it is preferable to record doses and hours of medications. Non-hospitalization must remain exceptional for non-severe decompensation with rapidly favorable evolution.
The French Observatory of Acute Heart Failure (OFICA) including nearly 1,800 patients specified epidemiological and therapeutic data of patients hospitalized for cardiogenic pulmonary edema in 2009. However, this study did not describe the initial management of the Mobile Emergency and Resuscitation Service and emergency services of hospitals. It is important to note that cardiogenic pulmonary edema initial management is decisive. In addition, early and adapted management of cardiogenic pulmonary edema is associated with a shorter hospital stay and reduced hospital mortality.
The Coronary Emergency Network (RESURCOR) within the Northern French Alps Emergency Network (RENAU) is an emergency care system structured in the departments of Isère, Savoie and Haute-Savoie. Its main goal is to help improve emergency management by using regional good practice guidelines (www.renau.org). In this context, projects aiming to evaluate professional practices are developed regularly. Since emergency management of cardiogenic pulmonary edema has not been evaluated, the Northern French Alps Emergency Network offers an approach to improve professional practices by defining and disseminating a guideline on cardiogenic pulmonary edema management which will then be assessed.
- Conditions
- Dyspnea, Paroxysmal, Heart Failure, Left Sided
- Being tested
- Baseline care, Referential's dissemination
- Medical subject headings
- Dyspnea, Paroxysmal, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline careOther
Referential's disseminationOther
| Study group | Role | What they receive |
|---|---|---|
| Baseline care | Patients treated for Cardiogenic Pulmonary Edema into the Northern French Alps Emergency Network between January 1, 2013 and December 31, 2013 Receives: Other: Baseline care | |
| Referential's dissemination | Patients treated for Cardiogenic Pulmonary Edema into the Northern French Alps Emergency Network between January 1, 2017 and December 31, 2017, after referential's dissemination for management of patients with paroxysmal dyspnea due to left sided heart failure Receives: Other: Referential's dissemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of quality of initial care of patients with cardiogenic pulmonary edema after dissemination of good practice standards
Two kinds of predefined quality indicators will be evaluated at different stages of care and compared among the two periods, before and after dissemination of good practice standards, looking for informations in medical charts during the management of patients either care by Mobile Emergency and Resuscitation Services or at emergency departments and in mails at time of hospital discharge).
Measured: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Secondary outcomes (10)
Patients' description at the onset of cardiogenic pulmonary edema (clinical)
Clinical characteristics of patients with cardiogenic pulmonary edema included in the two parts of this observational study (whole population).
Measured: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Patients' description at the onset of cardiogenic pulmonary edema (biological)
Biological characteristics of patients with cardiogenic pulmonary edema included in the two parts of this observational study (whole population).
Measured: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Patients' description at the onset of cardiogenic pulmonary edema (radiological)
Radiological characteristics of patients with cardiogenic pulmonary edema included in the two parts of this observational study (whole population).
Measured: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Patients' description at the onset of cardiogenic pulmonary edema (echocardiographic)
Echocardiographic characteristics of patients with cardiogenic pulmonary edema included in the two parts of this observational study (whole population).
Measured: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Mortality of patients hospitalized for cardiogenic pulmonary edema
number of patients dying during hospitalization for cardiogenic pulmonary edema
Measured: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Needs for Hospitalization in intensive care units
number (and rate) of patients with cardiogenic pulmonary edema, requiring hospitalization in intensive care unit
Measured: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Needs for respiratory assistance
number of patients and kind of respiratory assistance for patients with cardiogenic pulmonary edema
Measured: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Inter-services transfers
number of patients who require transfers from an emergency room (or a cardiology ward) to intensive care units and vice-versa
Measured: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Length of stay in hospital
number of days between arrival and discharge
Measured: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Re-hospitalizations during the first six months
number of re-hospitalizations during the first six months after the onset of cardiogenic pulmonary edema
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study startJan 2015
- Primary completionDec 2016
- Study completionJan 2018
Why it stopped: Only the first part of the study was done.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Dyspnea, ParoxysmalStudies of the same condition, open and under way.
- 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
- 859 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loic BELLE, MD, Study chair, Centre Hospitalier Annecy Genevois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148847
- Sponsor's protocol ID
- 2014-RENAU-1
- Acronym
- RENAU-OAP
- Status last verified
- Jun 2019
- First submitted
- 2 May 2017
- Last updated
- 18 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stewart S, MacIntyre K, Hole DJ, Capewell S, McMurray JJ. More 'malignant' than cancer? Five-year survival following a first admission for heart failure. Eur J Heart Fail. 2001 Jun;3(3):315-22. doi: 10.1016/s1388-9842(00)00141-0.
PubMed 11378002Mebazaa A, Gheorghiade M, Pina IL, Harjola VP, Hollenberg SM, Follath F, Rhodes A, Plaisance P, Roland E, Nieminen M, Komajda M, Parkhomenko A, Masip J, Zannad F, Filippatos G. Practical recommendations for prehospital and early in-hospital management of patients presenting with acute heart failure syndromes. Crit Care Med. 2008 Jan;36(1 Suppl):S129-39. doi: 10.1097/01.CCM.0000296274.51933.4C.
PubMed 18158472Heart Failure Society Of America. HFSA 2006 Comprehensive Heart Failure Practice Guideline. J Card Fail. 2006 Feb;12(1):e1-2. doi: 10.1016/j.cardfail.2005.11.005.
PubMed 16500560McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.
PubMed 22611136Emerman CL. Treatment of the acute decompensation of heart failure: efficacy and pharmacoeconomics of early initiation of therapy in the emergency department. Rev Cardiovasc Med. 2003;4 Suppl 7:S13-20.
PubMed 14668696Peacock WF 4th, Emerman CL. Emergency department management of patients with acute decompensated heart failure. Heart Fail Rev. 2004 Jul;9(3):187-93. doi: 10.1007/s10741-005-6128-5.
PubMed 15809816Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
PubMed 11794169Belle L, Fourny M, Reynaud T, Hammer L, Vanzetto G, Labarere J; RENAU-RESURCOR study investigators. Efficacy and safety of glycoprotein IIb/IIIa receptor antagonists for patients undergoing percutaneous coronary intervention within twelve hours of fibrinolysis. Catheter Cardiovasc Interv. 2011 Sep 1;78(3):376-84. doi: 10.1002/ccd.22825. Epub 2011 Mar 16.
PubMed 21413113Chacornac M, Baronne-Rochette G, Schmidt MH, Savary D, Habold D, Bouvaist H, Marliere S, Belle L, Machecourt J, Vanzetto G; REseau des URgences CORonariennes (RESURCOR). Characteristics and management of acute ST-segment elevation myocardial infarctions occurring in ski resorts in the French Alps: Impact of an acute coronary care network. Arch Cardiovasc Dis. 2010 Aug-Sep;103(8-9):460-8. doi: 10.1016/j.acvd.2010.09.002. Epub 2010 Oct 30.
PubMed 21074125Debaty G, Belle L, Labarere J, Fourny M, Torres JP, Savary D, Usseglio P, Menthonnex E, Guenot O, Vanzetto G. [Evolution of strategies of revascularisation in acute coronary syndromes with ST elevation. Analysis of the data of RESURCOR]. Arch Mal Coeur Vaiss. 2007 Feb;100(2):105-11. French.
PubMed 17474495Ferrier C, Belle L, Labarere J, Fourny M, Vanzetto G, Guenot O, Debaty G, Savary D, Machecourt J, Francois P. [Comparison of mortality according to the revascularisation strategies and the symptom-to-management delay in ST-segment elevation myocardial infarction]. Arch Mal Coeur Vaiss. 2007 Jan;100(1):13-9. French.
PubMed 17405549Fourny M, Belle L, Labarere J, Senee D, Savary D, Debaty G, Vanzetto G, Francois P. [Analysis of the accuracy of a coronary syndrome register]. Arch Mal Coeur Vaiss. 2006 Sep;99(9):798-803. French.
PubMed 17067098Fourny M, Lucas AS, Belle L, Debaty G, Casez P, Bouvaist H, Francois P, Vanzetto G, Labarere J. Inappropriate dispatcher decision for emergency medical service users with acute myocardial infarction. Am J Emerg Med. 2011 Jan;29(1):37-42. doi: 10.1016/j.ajem.2009.07.008. Epub 2010 Mar 9.
PubMed 20825772Zannad F, Briancon S, Juilliere Y, Mertes PM, Villemot JP, Alla F, Virion JM. Incidence, clinical and etiologic features, and outcomes of advanced chronic heart failure: the EPICAL Study. Epidemiologie de l'Insuffisance Cardiaque Avancee en Lorraine. J Am Coll Cardiol. 1999 Mar;33(3):734-42. doi: 10.1016/s0735-1097(98)00634-2.
PubMed 10080475Delahaye F, Roth O, Aupetit JF, de Gevigney G. [Epidemiology and prognosis of cardiac insufficiency]. Arch Mal Coeur Vaiss. 2001 Dec;94(12):1393-403. French.
PubMed 11828925
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Professional Practices on the Management of Cardiogenic Pulmonary Edema (RENAU-OAP)
- ClinicalTrials.gov ID
- NCT03148847
- Acronym / sponsor ID
- RENAU-OAP / 2014-RENAU-1
- Conditions
- Dyspnea, Paroxysmal, Heart Failure, Left Sided
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Only the first part of the study was done.
- Enrolment
- 859 participants (actual)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 11 May 2017 (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.
The prevalence of heart failure is estimated to 2.3 percent of the adult population and strongly increases with age, according to french disability-health surveys. In France, more than 32,000 annual deaths are attributable to heart failure and the five-year survival rate is similar to those found in many cancers. A better therapeutic management (angiotensin converting enzyme inhibitor and beta-blockers) helped reduce mortality after an episode of heart failure requiring hospitalization, but, nevertheless it remains high.
The severity of cardiogenic pulmonary edema depends on several factors such as etiology, hemodynamic status, effect on hematosis, and fatigue.
It is important to note that cardiogenic pulmonary edema initial management is decisive. In addition, early and adapted management of cardiogenic pulmonary edema is associated with a shorter hospital stay and reduced hospital mortality.
The Coronary Emergency Network (RESURCOR) within the Northern French Alps Emergency Network (RENAU) is an emergency care system structured in the departments of Isère, Savoie and Haute Savoie. Its main goal is to help improve emergency management by using regional good practice guidelines (www.renau.org). In this context, projects aiming to evaluate professional practices are developed regularly. Since emergency management of cardiogenic pulmonary edema has not been evaluated, the Northern French Alps Emergency Network offers an approach to improve professional practices by defining and disseminating guidelines on cardiogenic pulmonary edema management which will then be assessed.
Detailed description
The prevalence of heart failure is estimated to 2.3 percent of the adult population and strongly increases with age, according to disability-health surveys in France. In recent years, effective treatments (revascularization in percutaneous coronary intervention, circulatory assistance) helped reduce mortality in post-myocardial infarction, which combined with the increase of life expectancy has led to an increase number of patients with chronic heart failure. More than 32,000 annual deaths are attributable to heart failure and the five-year survival rate is similar to those found in cancers of the breast, bladder, colon, ovarian, and prostate. A better therapeutic management (angiotensin converting enzyme inhibitor and beta-blockers) helped reduce mortality after an episode of heart failure requiring hospitalization, but, nevertheless it remains high.
Main clinical manifestations are those of left heart failure, such as cardiogenic pulmonary edema which is a medical emergency. Treatment must take into account pathophysiological aspects of heart failure, etiologies of cardiogenic pulmonary edema and any potential factors or triggers apart from general measures. Two consensus statements and an international recommendation help define therapeutic strategies in this particular situation.
Signs suggestive of cardiogenic pulmonary edema include orthopnea, bilateral crackles or wheezing (patients over 70 years without known asthma), edema of the lower limbs, and gallop sound on heart auscultation. The evolution of these signs makes it particularly possible to manage the response to the treatment. The severity of cardiogenic pulmonary edema depends on several factors such as etiology (ECG analysis and chest pain assessment for acute coronary syndrome), hemodynamic status (blood pressure, heart rate), effect on hematosis (cyanosis, oxygen saturation), and fatigue (low respiratory rate with persistent cardiogenic pulmonary edema signs). The respiratory rate represents a simple clinical feature that can be used to quantify dyspnea (sign of severity if greater than 30 per minute in adults) and then follow its evolution (improvement, exhaustion). Disorders of consciousness can testify to the severity of the hemodynamic state and/or exhaustion.
Cardiogenic pulmonary edema management without shock implies urgent administration of vasodilators (trinitrin) and intravenous loop diuretics in presence of congestion signs along with the establishment of a system of care adapted to severity (Emergency Mobile Services or ambulance, hospitalization in Intensive Care Unit, intensive cardiology unit, cardiology or medicine department, or emergency passage). The subsequent therapeutic management will especially depend on initial treatment by the primary care physician, so it is preferable to record doses and hours of medications. Non-hospitalization must remain exceptional for non-severe decompensation with rapidly favorable evolution.
The French Observatory of Acute Heart Failure (OFICA) including nearly 1,800 patients specified epidemiological and therapeutic data of patients hospitalized for cardiogenic pulmonary edema in 2009. However, this study did not describe the initial management of the Mobile Emergency and Resuscitation Service and emergency services of hospitals. It is important to note that cardiogenic pulmonary edema initial management is decisive. In addition, early and adapted management of cardiogenic pulmonary edema is associated with a shorter hospital stay and reduced hospital mortality.
The Coronary Emergency Network (RESURCOR) within the Northern French Alps Emergency Network (RENAU) is an emergency care system structured in the departments of Isère, Savoie and Haute-Savoie. Its main goal is to help improve emergency management by using regional good practice guidelines (www.renau.org). In this context, projects aiming to evaluate professional practices are developed regularly. Since emergency management of cardiogenic pulmonary edema has not been evaluated, the Northern French Alps Emergency Network offers an approach to improve professional practices by defining and disseminating a guideline on cardiogenic pulmonary edema management which will then be assessed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline care | – | Other: Baseline carePatients treated for Cardiogenic Pulmonary Edema into the Northern French Alps Emergency Network between January 1, 2013 and December 31, 2013 |
| Referential's dissemination | – | Other: Referential's disseminationPatients treated for Cardiogenic Pulmonary Edema into the Northern French Alps Emergency Network between January 1, 2017 and December 31, 2017, after referential's dissemination for management of patients with paroxysmal dyspnea due to left sided heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As the goal of this study is to analyze common practices, data from the french medicalized information system program will be used to select a study population as exhaustive as possible. This program is dedicated to systematic collection of data from hospital stays. Each hospital stay is identified by a unique number and a diagnosis is attributed for each, at the end of every hospital stay. Diagnosis are based on the International Classification of Diseases (ICD-10). At hospital levels, a unique stay number can be related to names and addresses of involved patients. French medicalized information system program data are analyzed at a regional and then a national level. For this study, cases will be screened if they had a I500, I501 and I509 ICD-10 diagnosis (main or associated).
Key inclusion criteria (3 listed)
- ≥18 years old
- hospitalization during one of the two designed period (either year 2013, or year 2017) in a center belonging to Northern French Alps Emergency Network
- diagnosis of cardiogenic pulmonary edema, or heart failure (either left-sided, congestive or unspecified)
Key exclusion criteria (2 listed)
- people who refuse to have their health information used will not be included
- people whose care will have begun in a center not belonging to the Northern French Alps Emergency Network
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 |
|---|---|---|
| Baseline care | Other | Baseline care |
| Referential's dissemination | Other | Referential's dissemination |
Primary outcome
Change of quality of initial care of patients with cardiogenic pulmonary edema after dissemination of good practice standards
Time frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Two kinds of predefined quality indicators will be evaluated at different stages of care and compared among the two periods, before and after dissemination of good practice standards, looking for informations in medical charts during the management of patients either care by Mobile Emergency and Resuscitation Services or at emergency departments and in mails at time of hospital discharge).
10 secondary outcomes
Patients' description at the onset of cardiogenic pulmonary edema (clinical)
Time frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Patients' description at the onset of cardiogenic pulmonary edema (biological)
Time frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Patients' description at the onset of cardiogenic pulmonary edema (radiological)
Time frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Patients' description at the onset of cardiogenic pulmonary edema (echocardiographic)
Time frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Mortality of patients hospitalized for cardiogenic pulmonary edema
Time frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Needs for Hospitalization in intensive care units
Time frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Needs for respiratory assistance
Time frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Inter-services transfers
Time frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Length of stay in hospital
Time frame: an average of 1 week (length of hospitalization for cardiogenic pulmonary edema)
Re-hospitalizations during the first six months
Time frame: up to six months
Results and safety
The study was stopped early (reason given: Only the first part of the study was done.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Background: PubMed 11378002Stewart S, MacIntyre K, Hole DJ, Capewell S, McMurray JJ. More 'malignant' than cancer? Five-year survival following a first admission for heart failure. Eur J Heart Fail. 2001 Jun;3(3):315-22. doi: 10.1016/s1388-9842(00)00141-0.
- Background: PubMed 18158472Mebazaa A, Gheorghiade M, Pina IL, Harjola VP, Hollenberg SM, Follath F, Rhodes A, Plaisance P, Roland E, Nieminen M, Komajda M, Parkhomenko A, Masip J, Zannad F, Filippatos G. Practical recommendations for prehospital and early in-hospital management of patients presenting with acute heart failure syndromes. Crit Care Med. 2008 Jan;36(1 Suppl):S129-39. doi: 10.1097/01.CCM.0000296274.51933.4C.
- Background: PubMed 16500560Heart Failure Society Of America. HFSA 2006 Comprehensive Heart Failure Practice Guideline. J Card Fail. 2006 Feb;12(1):e1-2. doi: 10.1016/j.cardfail.2005.11.005.
- Background: PubMed 22611136McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.
- Background: PubMed 14668696Emerman CL. Treatment of the acute decompensation of heart failure: efficacy and pharmacoeconomics of early initiation of therapy in the emergency department. Rev Cardiovasc Med. 2003;4 Suppl 7:S13-20.
- Background: PubMed 15809816Peacock WF 4th, Emerman CL. Emergency department management of patients with acute decompensated heart failure. Heart Fail Rev. 2004 Jul;9(3):187-93. doi: 10.1007/s10741-005-6128-5.
- Background: PubMed 11794169Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
- Background: PubMed 21413113Belle L, Fourny M, Reynaud T, Hammer L, Vanzetto G, Labarere J; RENAU-RESURCOR study investigators. Efficacy and safety of glycoprotein IIb/IIIa receptor antagonists for patients undergoing percutaneous coronary intervention within twelve hours of fibrinolysis. Catheter Cardiovasc Interv. 2011 Sep 1;78(3):376-84. doi: 10.1002/ccd.22825. Epub 2011 Mar 16.
- Background: PubMed 21074125Chacornac M, Baronne-Rochette G, Schmidt MH, Savary D, Habold D, Bouvaist H, Marliere S, Belle L, Machecourt J, Vanzetto G; REseau des URgences CORonariennes (RESURCOR). Characteristics and management of acute ST-segment elevation myocardial infarctions occurring in ski resorts in the French Alps: Impact of an acute coronary care network. Arch Cardiovasc Dis. 2010 Aug-Sep;103(8-9):460-8. doi: 10.1016/j.acvd.2010.09.002. Epub 2010 Oct 30.
- Background: PubMed 17474495Debaty G, Belle L, Labarere J, Fourny M, Torres JP, Savary D, Usseglio P, Menthonnex E, Guenot O, Vanzetto G. [Evolution of strategies of revascularisation in acute coronary syndromes with ST elevation. Analysis of the data of RESURCOR]. Arch Mal Coeur Vaiss. 2007 Feb;100(2):105-11. French.
- Background: PubMed 17405549Ferrier C, Belle L, Labarere J, Fourny M, Vanzetto G, Guenot O, Debaty G, Savary D, Machecourt J, Francois P. [Comparison of mortality according to the revascularisation strategies and the symptom-to-management delay in ST-segment elevation myocardial infarction]. Arch Mal Coeur Vaiss. 2007 Jan;100(1):13-9. French.
- Background: PubMed 17067098Fourny M, Belle L, Labarere J, Senee D, Savary D, Debaty G, Vanzetto G, Francois P. [Analysis of the accuracy of a coronary syndrome register]. Arch Mal Coeur Vaiss. 2006 Sep;99(9):798-803. French.
- 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.
Loic BELLE, MD study chair
Centre Hospitalier Annecy Genevois
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 Dyspnea, Paroxysmal and Heart Failure, Left Sided, run by Centre Hospitalier Annecy Genevois 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 3 inclusion and 2 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 18 Jun 2019. 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?
The study was stopped early (reason given: Only the first part of the study was done.). 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?
Change of quality of initial care of patients with cardiogenic pulmonary edema after dissemination of good practice standards (time frame: an average of 1 week (length of hospitalization for cardiogenic 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 NCT03148847, which also lists 22 linked publications.
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 18 Jun 2019.