Pulmonary EdemaNCT00829855
Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema
An observational study of Pulmonary Edema and Hypertension, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Acute cardiogenic pulmonary edema (ACPE), one of the most severe forms of acute heart failure, represents 5% of hospital admissions. One of the most frequent phenomena encountered during ACPE is hypertensive crisis (hypertensive ACPE) but the mechanisms and causes of hypertensive ACPE are insufficiently understood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Edema, Hypertension
- How many people
- 51 participants
- Where
- 1 siteRomania
- Study dates
- May 2008to May 2009
- 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: Patients admitted in the Cardiac Care Unit of an University and Emergency Hospital, with a diagnosis of acute cardiogenic pulmonary edema associated with hypertension (systolic blood pressure ≥160 mmHg)
Who may be able to join
- acute onset of dyspnea within the preceding 8 hours
- respiratory distress and pulmonary rales at any level
- pulmonary congestion confirmed by chest radiography
- systolic blood pressure > 160 mmHg before treatment
- sinus rhythm
- signed informed consent
Who cannot join
- acute myocardial infarction confirmed by myocardial necrosis markers (either CKMB or troponin I). Angina pectoris alone will not be excluded
- significant left sided valvular disease (more than moderate). Mitral regurgitation of any severity will not be excluded, due to the hypothesis of the role of dynamic mitral regurgitation in the pathogenesis of acute hypertensive pulmonary edema
- congenital heart disease
- cardiac tamponade
- rhythm and conduction disturbances that may have precipitated pulmonary edema, like sustained ventricular tachycardia and complete heart block
Trial locations and contacts
1 site in 1 country.
Romania1 site
Department of Cardiology, University and Emergency Hospital of Bucharest
Bucharest, 050098
About this study
Acute cardiogenic pulmonary edema (ACPE), one of the most severe forms of acute heart failure, represents 5% of hospital admissions. One of the most frequent phenomena encountered during ACPE is hypertensive crisis (hypertensive ACPE) but the mechanisms and causes of hypertensive ACPE are insufficiently understood. Few studies have evaluated the cardiac function during hypertensive ACPE, and these studies used only conventional echocardiography methods. New methods of evaluation of cardiac function in hypertensive ACPE (such as Tissue Doppler imaging) have not been used.
The objectives of this study are to evaluate presence and role of the following potential mechanisms of hypertensive ACPE: 1. acute myocardial dysfunction (systolic and diastolic); 2. silent transient myocardial ischemia; 3. acute mechanical left ventricular dyssynchrony; 4. dynamic mitral regurgitation; 5. inter-ventricular interaction. Conventional and Tissue Doppler echocardiography will be used to assess cardiac function.
- Conditions
- Pulmonary Edema, Hypertension
- Keywords
- pulmonary edema, hypertension, echocardiography
- Medical subject headings
- Pulmonary Edema, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with hypertensive (systolic blood pressure ≥160 mmHg) acute pulmonary edema, evaluated within 120 minutes after admittance. | |
| 2 | The same patients from group 1 followed-up at 48 to 96 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute myocardial dysfunction (systolic and diastolic) and/or dyssynchrony
Measured: acute event and 48 to 96 h after the event
Secondary outcomes (3)
surrogate markers of silent transient myocardial ischemia
Measured: acute event and 48 to 96 h after the event
dynamic mitral regurgitation
Measured: acute event and 48 to 96 h after the event
inter-ventricular interaction
Measured: acute event and 48 to 96h after the event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EdemaStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Davila University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Research, Youth and Sport, Romania
- Responsible party
- Principal investigator, Mircea Cinteza, Carol Davila University of Medicine and Pharmacy
- Investigators
- Mircea Cinteza, MD, PhD, Principal investigator, University of Medicine and Pharmacy "Carol Davila" BucharestDragos Vinereanu, MD, PhD, Principal investigator, University of Medicine and Pharmacy "Carol Davila" BucharestAndrei D Margulescu, MD, Study chair, University of Medicine and Pharmacy "Carol Davila" Bucharest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829855
- Sponsor's protocol ID
- IDEI_242_2007
- Other IDs
- ID_216/PNII_242_2007
- Status last verified
- Mar 2013
- First submitted
- 26 Jan 2009
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema
- ClinicalTrials.gov ID
- NCT00829855
- Acronym / sponsor ID
- IDEI_242_2007
- Conditions
- Pulmonary Edema, Hypertension
- Keywords
- pulmonary edema, hypertension, echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Carol Davila University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Ministry of Education, Research, Youth and Sport, Romania
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 27 Jan 2009 (estimated)
- 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.
Acute cardiogenic pulmonary edema (ACPE), one of the most severe forms of acute heart failure, represents 5% of hospital admissions. One of the most frequent phenomena encountered during ACPE is hypertensive crisis (hypertensive ACPE) but the mechanisms and causes of hypertensive ACPE are insufficiently understood. Few studies have evaluated the cardiac function during hypertensive ACPE, and these studies used only conventional echocardiography methods. New methods of evaluation of cardiac function in hypertensive ACPE (such as Tissue Doppler imaging) have not been used.
The objectives of this study are to evaluate presence and role of the following potential mechanisms of hypertensive ACPE: 1. acute myocardial dysfunction (systolic and diastolic); 2. silent transient myocardial ischemia; 3. acute mechanical left ventricular dyssynchrony; 4. dynamic mitral regurgitation; 5. inter-ventricular interaction. Conventional and Tissue Doppler echocardiography will be used to assess cardiac function.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with hypertensive (systolic blood pressure ≥160 mmHg) acute pulmonary edema, evaluated within 120 minutes after admittance. |
| 2 | – | –The same patients from group 1 followed-up at 48 to 96 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in the Cardiac Care Unit of an University and Emergency Hospital, with a diagnosis of acute cardiogenic pulmonary edema associated with hypertension (systolic blood pressure ≥160 mmHg)
Key inclusion criteria (6 listed)
- acute onset of dyspnea within the preceding 8 hours
- respiratory distress and pulmonary rales at any level
- pulmonary congestion confirmed by chest radiography
- systolic blood pressure > 160 mmHg before treatment
- sinus rhythm
Key exclusion criteria (5 listed)
- acute myocardial infarction confirmed by myocardial necrosis markers (either CKMB or troponin I). Angina pectoris alone will not be excluded
- significant left sided valvular disease (more than moderate). Mitral regurgitation of any severity will not be excluded, due to the hypothesis of the role of dynamic mitral regurgitation in the pathogenesis of acute hypertensive pulmonary edema
- congenital heart disease
- cardiac tamponade
- rhythm and conduction disturbances that may have precipitated pulmonary edema, like sustained ventricular tachycardia and complete heart block
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
acute myocardial dysfunction (systolic and diastolic) and/or dyssynchrony
Time frame: acute event and 48 to 96 h after the event
3 secondary outcomes
surrogate markers of silent transient myocardial ischemia
Time frame: acute event and 48 to 96 h after the event
dynamic mitral regurgitation
Time frame: acute event and 48 to 96 h after the event
inter-ventricular interaction
Time frame: acute event and 48 to 96h after the event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
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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.
Mircea Cinteza, MD, PhD principal investigator
University of Medicine and Pharmacy "Carol Davila" Bucharest
Dragos Vinereanu, MD, PhD principal investigator
University of Medicine and Pharmacy "Carol Davila" Bucharest
Andrei D Margulescu, MD study chair
University of Medicine and Pharmacy "Carol Davila" Bucharest
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 Pulmonary Edema and Hypertension, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 5 Mar 2013. 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 Romania. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
acute myocardial dysfunction (systolic and diastolic) and/or dyssynchrony (time frame: acute event and 48 to 96 h after the event). 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 5 Mar 2013.