Clinical trial NCT00829855: Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema
Official title: Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Edema
Hypertension
Keywords: pulmonary edema
hypertension
echocardiography
Lead sponsor: Carol Davila University of Medicine and Pharmacy
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Research, Youth and Sport, Romania
First posted: 2009-01-27
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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)

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion criteria:

* 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

Primary outcomes:
measure: acute myocardial dysfunction (systolic and diastolic) and/or dyssynchrony
timeFrame: acute event and 48 to 96 h after the event
Secondary outcomes:
measure: surrogate markers of silent transient myocardial ischemia
timeFrame: acute event and 48 to 96 h after the event
measure: dynamic mitral regurgitation
timeFrame: acute event and 48 to 96 h after the event
measure: inter-ventricular interaction
timeFrame: acute event and 48 to 96h after the event
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Department of Cardiology, University and Emergency Hospital of Bucharest
Study officials:
affiliation: University of Medicine and Pharmacy "Carol Davila" Bucharest
name: Mircea Cinteza, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Medicine and Pharmacy "Carol Davila" Bucharest
name: Dragos Vinereanu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Medicine and Pharmacy "Carol Davila" Bucharest
name: Andrei D Margulescu, MD
role: STUDY_CHAIR
References: