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

Phase 3

Completed

• Conditions: Heart Failure
• Interventions: Other: Usual treatment of patients with developing acute heart failure; Device: Lung Impedance-Guided Therapy

• Registration Number: NCT01616121
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06-01
• Study First Submitted: 2012-05-31
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-11
• Primary Completion: 2014-07-01
• Study Completion: 2014-07-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-17
• Last Update Posted: 2020-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 654

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Treatment Heart Failure	Usual treatment of patients with developing acute heart failure	Conventional Treatment
Lung Impedance-Guided Therapy	Lung Impedance-Guided Therapy	Lung Impedance-Guided Therapy

Primary Outcome Measures

Name	Time	Method
Prevention of acute heart failure development in acute MI patients	Three years

Secondary Outcome Measures

Name	Time	Method
Improvement of clinical outcome in patients with lung impedance-guided treatments	Three years

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel