Outpatient Lung Impedance-Guided Preventive Therapy in Patients With Chronic Heart Failure (CHF)

NCT ID: NCT01315223

Last Updated: 2016-07-21

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2018-06-30

Brief Summary

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Patients suffering from Chronic Heart Failure (CHF) are hospitalized for acute heart failure (AHF) several times a year. Currently, we have no method for prediction of future developments of AHF. In our center we have investigated the monitoring of lung impedence as a predictor for future deterioration. It was found that a decrease in lung impedence of more than 15% from normal value predicts AHF development with sensitivity of 98%. In this study we try to prove the hypothesis that preventive treatment according to lung impedence value may prevent future hospitalizations for AHF and improve clinical outcome.

Patients recruited by year:

2011 - 50; 2012 - 25; 2013 - 35; 2014 - 30; 2015 - 50; 2016 - 5

Detailed Description

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Conditions

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Chronic Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Conventional treatment CHF patients

One hundred and fifty patients with CHF will be treated according to current guidelines (conventional treatment).

Group Type NO_INTERVENTION

No interventions assigned to this group

Lung impedence-guided treatment

Group Type EXPERIMENTAL

Lung impedence-guided treatment

Intervention Type OTHER

One hundred fifty patients with CHF will be treated according to common practice and values of lung impedance

Interventions

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Lung impedence-guided treatment

One hundred fifty patients with CHF will be treated according to common practice and values of lung impedance

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from CHF, NYHA II-IV class
* LV lower than 35% to LV lower than 45%

Exclusion Criteria

* Patients with additional disease with life-expectancy of less than 2 years
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 RECRUITING

Countries

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Israel

Facility Contacts

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Michael Shochat, MD

Role: primary

972-4-630-4484

References

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Kleiner Shochat M, Fudim M, Kapustin D, Kazatsker M, Kleiner I, Weinstein JM, Panjrath G, Rozen G, Roguin A, Meisel SR. Early Impedance-Guided Intervention Improves Long-Term Outcome in Patients With Heart Failure. J Am Coll Cardiol. 2021 Oct 26;78(17):1751-1752. doi: 10.1016/j.jacc.2021.08.036. No abstract available.

Reference Type DERIVED
PMID: 34674821 (View on PubMed)

Shochat MK, Shotan A, Blondheim DS, Kazatsker M, Dahan I, Asif A, Rozenman Y, Kleiner I, Weinstein JM, Frimerman A, Vasilenko L, Meisel SR. Non-Invasive Lung IMPEDANCE-Guided Preemptive Treatment in Chronic Heart Failure Patients: A Randomized Controlled Trial (IMPEDANCE-HF Trial). J Card Fail. 2016 Sep;22(9):713-22. doi: 10.1016/j.cardfail.2016.03.015. Epub 2016 Apr 4.

Reference Type DERIVED
PMID: 27058408 (View on PubMed)

Other Identifiers

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0010-11-HYMC

Identifier Type: -

Identifier Source: org_study_id

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