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Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial

Primary Purpose

Congestive Heart Failure

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
uCor
Sponsored by
Kyma Medical Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congestive Heart Failure

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or women 20-90 years old.
  • New York Heart Association (NYHA) class III-IV heart failure
  • Followed by the Congestive Heart Failure (CHF) clinic in Nazareth
  • Left ventricular ejection fraction <35%
  • Requiring treatment with >40mg/day of furosemide* orally or with repeated bolus or intravenous infusion of furosemide* (*or equivalent bumetanide or torasemide).

Exclusion Criteria:

  • Pregnancy
  • Subjects who have received a heart transplant.
  • Subjects who are unable or unwilling to follow the study requirements.
  • Patients with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
  • Patients with skin breakdown in areas on the chest where device and electrode placement is required

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    uCor

    Arm Description

    For subjects in the Control arm, the parameters measured by the (µ-Cor) µ-Cor system will not be analysed or made available to the investigator.

    For subjects in the Interventional arm, all of the parameters measured by the (µ-Cor) µ-Cor system will be available to the investigator and will remain blinded to the subjects. The investigator will use µ-Cor information to aid in therapy adjustment decisions during the study period.

    Outcomes

    Primary Outcome Measures

    composite of all-cause death or hospitalizations due to heart failure in the Interventional arm compared to the Control arm.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 2, 2016
    Last Updated
    August 10, 2020
    Sponsor
    Kyma Medical Technologies
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02700191
    Brief Title
    Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial
    Official Title
    Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of interest by Investigators
    Study Start Date
    May 4, 2016 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kyma Medical Technologies

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Subjects that are being treated at the Congestive Heart Failure clinic in Nazareth will be given the µ-Cor system to be added to their standard care, and randomized 1:1 to an interventional arm or a control arm.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Congestive Heart Failure

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    For subjects in the Control arm, the parameters measured by the (µ-Cor) µ-Cor system will not be analysed or made available to the investigator.
    Arm Title
    uCor
    Arm Type
    Experimental
    Arm Description
    For subjects in the Interventional arm, all of the parameters measured by the (µ-Cor) µ-Cor system will be available to the investigator and will remain blinded to the subjects. The investigator will use µ-Cor information to aid in therapy adjustment decisions during the study period.
    Intervention Type
    Device
    Intervention Name(s)
    uCor
    Primary Outcome Measure Information:
    Title
    composite of all-cause death or hospitalizations due to heart failure in the Interventional arm compared to the Control arm.
    Time Frame
    30 days to 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men or women 20-90 years old. New York Heart Association (NYHA) class III-IV heart failure Followed by the Congestive Heart Failure (CHF) clinic in Nazareth Left ventricular ejection fraction <35% Requiring treatment with >40mg/day of furosemide* orally or with repeated bolus or intravenous infusion of furosemide* (*or equivalent bumetanide or torasemide). Exclusion Criteria: Pregnancy Subjects who have received a heart transplant. Subjects who are unable or unwilling to follow the study requirements. Patients with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive. Patients with skin breakdown in areas on the chest where device and electrode placement is required

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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