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NCT01616121 Clinical Trial

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

Heart Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01616121
Other study ID # 0037-12-HYMC
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 1, 2002
Est. completion date July 1, 2014

Study information
Verified date June 2020
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 654
Est. completion date July 1, 2014
Est. primary completion date July 1, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Usual treatment of patients with developing acute heart failure

Device:
• Lung Impedance-Guided Therapy
Non-invasive lung impedance monitor (RSMM Company, Tel Aviv, Israel)

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevention of acute heart failure development in acute MI patients Three years
Secondary Improvement of clinical outcome in patients with lung impedance-guided treatments Three years
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