Back to resultsPreemptive Lung Impedance-guided Therapy of Evolving Acute Heart Failure in Acute Myocardial Infarction Patients
Primary Purpose
Acute Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Lung impedence-guided therapy
Usual treatment of patients with developing acute heart failure
Sponsored by
About this trial
This is an interventional treatment trial for Acute Heart Failure focused on measuring Developing acute heart failure
Eligibility 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
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control
Lung impedence-guided treatment
Arm Description
Outcomes
Primary Outcome Measures
Prevention of acute heart failure development in acute MI patients
Secondary Outcome Measures
Improvement of clinical outcome in patients with lung impedence-guided treatments
Full Information
NCT ID
NCT01264159
First Posted
December 20, 2010
Last Updated
June 10, 2020
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01264159
Brief Title
Preemptive Lung Impedance-guided Therapy of Evolving Acute Heart Failure in Acute Myocardial Infarction Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
The principle investigator decided to change the protocol
Study Start Date
January 1, 2011 (Actual)
Primary Completion Date
January 1, 2015 (Actual)
Study Completion Date
July 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
Keywords
Developing acute heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Title
Lung impedence-guided treatment
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Lung impedence-guided therapy
Intervention Type
Other
Intervention Name(s)
Usual treatment of patients with developing acute heart failure
Primary Outcome Measure Information:
Title
Prevention of acute heart failure development in acute MI patients
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Improvement of clinical outcome in patients with lung impedence-guided treatments
Time Frame
Three years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Preemptive Lung Impedance-guided Therapy of Evolving Acute Heart Failure in Acute Myocardial Infarction Patients
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