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Preemptive Lung Impedance-guided Therapy of Evolving Acute Heart Failure in Acute Myocardial Infarction Patients

This study has been terminated.
(The principle investigator decided to change the protocol)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01264159
First Posted: December 21, 2010
Last Update Posted: June 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
  Purpose
It is well known that 20-25% of patients hospitalized for acute myocardial infarction will develop acute heart failure during their hospitalization. Currently, the investigators have no reliable parameter for prediction of evolving acute heart failure in such a group of patients. As a result, the investigators have no way of preventing acute heart failure. Treatment of these patients only begins after appearance of clinical signs of acute heart failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of evolving acute heart failure. This study will attempt to address whether preemptive lung impedence-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.

Condition Intervention
Acute Heart Failure Device: Lung impedence-guided therapy Other: Usual treatment of patients with developing acute heart failure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Prevention of acute heart failure development in acute MI patients [ Time Frame: Three years ]

Secondary Outcome Measures:
  • Improvement of clinical outcome in patients with lung impedence-guided treatments [ Time Frame: Three years ]

Enrollment: 70
Study Start Date: January 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Other: Usual treatment of patients with developing acute heart failure
Active Comparator: Lung impedence-guided treatment Device: Lung impedence-guided therapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure during their hospitalization

Exclusion Criteria:

  • Patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264159


Locations
Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01264159     History of Changes
Other Study ID Numbers: 0090-10-HYMC
First Submitted: December 20, 2010
First Posted: December 21, 2010
Last Update Posted: June 1, 2012
Last Verified: May 2012

Keywords provided by Hillel Yaffe Medical Center:
Developing acute heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases