Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema - Full Text View

Sponsors and Collaborators:	Carol Davila University of Medicine and Pharmacy Ministry of Education and Research, Romania
Information provided by:	Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier:	NCT00829855

Purpose

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
Pulmonary Edema Hypertension

Study Type:	Observational
Study Design:	Case-Crossover, Prospective
Official Title:	Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema

Resource links provided by NLM:

MedlinePlus related topics: Edema High Blood Pressure

U.S. FDA Resources

Further study details as provided by Carol Davila University of Medicine and Pharmacy:

Primary Outcome Measures:

acute myocardial dysfunction (systolic and diastolic) and/or dyssynchrony [ Time Frame: acute event and 48 to 96 h after the event ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

surrogate markers of silent transient myocardial ischemia [ Time Frame: acute event and 48 to 96 h after the event ] [ Designated as safety issue: No ]
dynamic mitral regurgitation [ Time Frame: acute event and 48 to 96 h after the event ] [ Designated as safety issue: No ]
inter-ventricular interaction [ Time Frame: acute event and 48 to 96h after the event ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	51
Study Start Date:	May 2008
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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)

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829855

Locations

Romania
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 and Research, 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

More Information

No publications provided

Responsible Party:	University of Medicine and Pharmacy "Carol Davila" Bucharest ( Professor Mircea Cinteza, MD, PhD )
Study ID Numbers:	IDEI_242_2007, ID_216/PNII_242_2007
Study First Received:	January 26, 2009
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00829855 History of Changes
Health Authority:	Romania: National Authority for Scientific Research

Keywords provided by Carol Davila University of Medicine and Pharmacy:

pulmonary edema
hypertension
echocardiography

Study placed in the following topic categories:

Signs and Symptoms
Pulmonary Edema
Respiratory Tract Diseases
Lung Diseases

Vascular Diseases
Edema
Hypertension

Additional relevant MeSH terms:

Signs and Symptoms
Pulmonary Edema
Respiratory Tract Diseases
Lung Diseases

Vascular Diseases
Edema
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on September 10, 2009