Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema

Sponsor

Carol Davila University of Medicine and Pharmacy (Other)

Overall Status

Completed

CT.gov ID

NCT00829855

Collaborator

Ministry of Education, Research, Youth and Sport, Romania (Other)

Enrollment

Location

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Edema Hypertension

Study Design

Study Type:

Observational

Actual Enrollment :

51 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

acute myocardial dysfunction (systolic and diastolic) and/or dyssynchrony [acute event and 48 to 96 h after the event]

Secondary Outcome Measures

surrogate markers of silent transient myocardial ischemia [acute event and 48 to 96 h after the event]
dynamic mitral regurgitation [acute event and 48 to 96 h after the event]
inter-ventricular interaction [acute event and 48 to 96h after the event]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiology, University and Emergency Hospital of Bucharest	Bucharest		Romania	050098

Sponsors and Collaborators

Carol Davila University of Medicine and Pharmacy
Ministry of Education, Research, Youth and Sport, Romania

Investigators

Principal Investigator: Mircea Cinteza, MD, PhD, University of Medicine and Pharmacy "Carol Davila" Bucharest
Principal Investigator: Dragos Vinereanu, MD, PhD, University of Medicine and Pharmacy "Carol Davila" Bucharest
Study Chair: Andrei D Margulescu, MD, University of Medicine and Pharmacy "Carol Davila" Bucharest