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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
  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:


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
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: 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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014