NCT02661841

Brief Summary

We aim to determine the effectiveness of lung impedance guided preemptive therapy (LI-Guided) of chronic heart failure patients with preserved ejection fraction (LVEF ≥ 45%) who are being treated in our hospital's outpatient clinic.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

5.9 years

First QC Date

January 20, 2016

Last Update Submit

June 17, 2020

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Reduced all cause, cardiovascular, and heart failure hospitalizations

    Five years

  • Reduced mortality

    Five years

Study Arms (2)

LI-Guided Therapy

EXPERIMENTAL

One hundred and fifty chronic heart failure patients treated based on guidelines and LI-Guided Therapy.

Other: LI-Guided TherapyOther: Heart Failure Guidelines

Control

ACTIVE COMPARATOR

One hundred and fifty chronic heart failure patients treated based on guidelines only.

Other: Heart Failure Guidelines

Interventions

LI-Guided TherapyOTHER

Preemptive treatment according to LI monitoring

LI-Guided Therapy
Heart Failure GuidelinesOTHER

Treatment according to clinical signs

ControlLI-Guided Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients hospitalized within past 12 months for heart failure

You may not qualify if:

  • Dialysis patients
  • Patients with GFR \<25
  • Patients with serious illness and life expectancy \<12
  • Mentally incompetent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Michael Shochat, MD, PhD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Shochat, MD, PhD

CONTACT

972-4-630-4491shochat1@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

January 25, 2016

Study Start

February 1, 2016

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)