Back to resultsPreemptive Lung Impedance-Guided Therapy in Evolving Acute Heart Failure in Acute Myocardial Infarction Patients
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Usual treatment of patients with developing acute heart failure
Lung Impedance-Guided Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure
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
Active Comparator
Experimental
Arm Label
Conventional Treatment Heart Failure
Lung Impedance-Guided Therapy
Arm Description
Conventional Treatment
Lung Impedance-Guided Therapy
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 impedance-guided treatments
Full Information
NCT ID
NCT01616121
First Posted
May 31, 2012
Last Updated
June 17, 2020
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01616121
Brief Title
Preemptive Lung Impedance-Guided Therapy in Evolving Acute Heart Failure in Acute Myocardial Infarction Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2002 (Actual)
Primary Completion Date
July 1, 2014 (Actual)
Study Completion Date
July 1, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
Yes
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 impedance-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
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
In this study the interventional group was treated preemptively according to the lung-impedance protocol and the control group was treated only according to clinical assessment.
Masking
Participant
Allocation
Randomized
Enrollment
654 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Treatment Heart Failure
Arm Type
Active Comparator
Arm Description
Conventional Treatment
Arm Title
Lung Impedance-Guided Therapy
Arm Type
Experimental
Arm Description
Lung Impedance-Guided Therapy
Intervention Type
Other
Intervention Name(s)
Usual treatment of patients with developing acute heart failure
Intervention Type
Device
Intervention Name(s)
Lung Impedance-Guided Therapy
Intervention Description
Non-invasive lung impedance monitor (RSMM Company, Tel Aviv, Israel)
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 impedance-guided treatments
Time Frame
Three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure
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 in Evolving Acute Heart Failure in Acute Myocardial Infarction Patients
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