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

NCT ID: NCT01616121

Last Updated: 2020-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

654 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-01

Study Completion Date

2014-07-01

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional Treatment Heart Failure

Conventional Treatment

Group Type ACTIVE_COMPARATOR

Usual treatment of patients with developing acute heart failure

Intervention Type OTHER

Lung Impedance-Guided Therapy

Lung Impedance-Guided Therapy

Group Type EXPERIMENTAL

Lung Impedance-Guided Therapy

Intervention Type DEVICE

Non-invasive lung impedance monitor (RSMM Company, Tel Aviv, Israel)

Interventions

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Usual treatment of patients with developing acute heart failure

Intervention Type OTHER

Lung Impedance-Guided Therapy

Non-invasive lung impedance monitor (RSMM Company, Tel Aviv, Israel)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0037-12-HYMC

Identifier Type: -

Identifier Source: org_study_id

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