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

• Sponsor: Hillel Yaffe Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01264159
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 53.9
• Patients Per Site Per Month: 1.3

Study Details

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 impedence-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.

Condition or Disease	Intervention/Treatment	Phase
Acute Heart Failure	Device: Lung impedence-guided therapy; Other: Usual treatment of patients with developing acute heart failure	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Actual Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control	Other: Usual treatment of patients with developing acute heart failure
Active Comparator: Lung impedence-guided treatment	Device: Lung impedence-guided therapy

Outcome Measures

Primary Outcome Measures

1. Prevention of acute heart failure development in acute MI patients [Three years]

Secondary Outcome Measures

1. Improvement of clinical outcome in patients with lung impedence-guided treatments [Three years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure during their hospitalization

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hillel Yaffe Medical Center	Hadera		Israel	38100

Sponsors and Collaborators

• Hillel Yaffe Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hillel Yaffe Medical Center
• ClinicalTrials.gov Identifier: NCT01264159
• Other Study ID Numbers: 0090-10-HYMC
• First Posted: Dec 21, 2010
• Last Update Posted: Jun 11, 2020
• Last Verified: Jun 1, 2020

• Keywords provided by Hillel Yaffe Medical Center: Developing acute heart failure
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Jun 11, 2020