Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema

This study has been completed.
Sponsor:
Collaborator:
Ministry of Education and Research, Romania
Information provided by (Responsible Party):
Mircea Cinteza, Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier:
NCT00829855
First received: January 26, 2009
Last updated: March 4, 2013
Last verified: March 2013
  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: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Echocardiographic Evaluation of Hypertensive Acute Pulmonary Edema

Resource links provided by NLM:


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 ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Mircea Cinteza, Professor, Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT00829855     History of Changes
Other Study ID Numbers: IDEI_242_2007, ID_216/PNII_242_2007
Study First Received: January 26, 2009
Last Updated: March 4, 2013
Health Authority: Romania: National Authority for Scientific Research

Keywords provided by Carol Davila University of Medicine and Pharmacy:
pulmonary edema
hypertension
echocardiography

Additional relevant MeSH terms:
Edema
Hypertension
Pulmonary Edema
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014