Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema

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.

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Key information

Conditions

Pulmonary Edema Cardiovascular Diseases Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, University and Emergency Hospital of Bucharest

Bucharest, 050098, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

acute myocardial dysfunction (systolic and diastolic) and/or dyssynchrony

Time frame: acute event and 48 to 96 h after the event

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

Sponsors and collaborators

Lead sponsor

Carol Davila University of Medicine and Pharmacy

Other

Collaborators

Ministry of Education, Research, Youth and Sport, Romania

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Jan 27, 2009
Registry last updated: Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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