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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:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01264159
First received: December 20, 2010
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of clinical outcome in patients with lung impedence-guided treatments [ Time Frame: Three years ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264159

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

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01264159     History of Changes
Other Study ID Numbers: 0090-10-HYMC
Study First Received: December 20, 2010
Last Updated: May 31, 2012
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Heart Failure
Myocardial Infarction
Heart Diseases
 Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013