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

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ClinicalTrials.gov Identifier: NCT01616121
Recruitment Status : Recruiting
First Posted : June 11, 2012
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Usual treatment of patients with developing acute heart failure Device: Lung Impedance-Guided Therapy Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : June 2012
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Conventional Treatment Heart Failure
Conventional Treatment
Other: Usual treatment of patients with developing acute heart failure
Experimental: Lung Impedance-Guided Therapy
Lung Impedance-Guided Therapy
Device: Lung Impedance-Guided Therapy
Non-invasive lung impedance monitor (RSMM Company, Tel Aviv, Israel)



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (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

Exclusion Criteria:

  • Patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission

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): NCT01616121


Contacts
Contact: Michael Shochat, MD, PhD 972-50-6246926 shochat1@yahoo.com

Locations
Israel
Hillel Yaffe Medical Center Recruiting
Hadera, Israel, 38100
Contact: Michael Shochat, MD, PhD         
Principal Investigator: Michael Shochat, MD, PhD         
Sponsors and Collaborators
Hillel Yaffe Medical Center

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01616121     History of Changes
Other Study ID Numbers: 0037-12-HYMC
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases