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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Pulmonary Edema

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania, 050098
    • Department of Cardiology, University and Emergency Hospital of Bucharest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
acute myocardial dysfunction (systolic and diastolic) and/or dyssynchrony	acute event and 48 to 96 h after the event

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Carol Davila University of Medicine and Pharmacy
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: January 26, 2009
• First Submitted That Met QC Criteria: January 26, 2009
• First Posted (Estimate): January 27, 2009

Study Record Updates

• Last Update Posted (Estimate): March 5, 2013
• Last Update Submitted That Met QC Criteria: March 4, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: hypertension; echocardiography; pulmonary edema
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Edema; Pulmonary Edema
• Other Study ID Numbers: IDEI_242_2007; ID_216/PNII_242_2007