Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema

Hypertension Clinical Trial

Official title:

Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829855
• Other study ID #: IDEI_242_2007
• Secondary ID: ID_216/PNII_242_
• Status: Completed
• Phase: N/A
• First received: January 26, 2009
• Last updated: March 4, 2013
• Start date: May 2008
• Est. completion date: May 2009

Study information

• Verified date: March 2013
• Source: Carol Davila University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Authority for Scientific Research
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Edema
• Hypertension
• Pulmonary Edema

Locations

Country	Name	City	State
Romania	Department of Cardiology, University and Emergency Hospital of Bucharest	Bucharest

Sponsors (2)

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

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute myocardial dysfunction (systolic and diastolic) and/or dyssynchrony		acute event and 48 to 96 h after the event	No
Secondary	surrogate markers of silent transient myocardial ischemia		acute event and 48 to 96 h after the event	No
Secondary	dynamic mitral regurgitation		acute event and 48 to 96 h after the event	No
Secondary	inter-ventricular interaction		acute event and 48 to 96h after the event	No