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DECIDE-HF: Heart Rate Variability in Heart Failure Patients

Sponsor
Medtronic BRC (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00949676
Collaborator
(none)
60
Enrollment
5
Locations
51
Duration (Months)
12
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether heart rate variability-like parameters are related to changes in the disease status of a subject that suffers from a disease that decreases the pumping function of the heart.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    DECIDE-HF - Heart Rate Variability in Heart Failure Patients
    Study Start Date :
    Sep 1, 2009
    Anticipated Primary Completion Date :
    Nov 1, 2013
    Anticipated Study Completion Date :
    Dec 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Heart Failure

    Outcome Measures

    Primary Outcome Measures

    1. HF diagnostic [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subject has signed and dated the study-specific informed consent form

    • Subject is 18 years of age or older

    • Subject is expected to remain available for follow-ups

    • Subject is able and willing to comply with the protocol requirements

    • Subject has predominant Normal Sinus Rhythm

    • Subject has systolic Heart Failure and is at the moment of enrollment in NYHA class II or III and has an ejection fraction of less then 40%

    • Subject has had a HF-related hospitalization in the past 12 months

    Exclusion Criteria:

    • Subject needs permanent atrial pacing (> 10%)

    • Subject has intermittent 2nd or intermittent 3rd degree block

    • Subject has persistent or permanent AF

    • Subject has Long QT syndrome, Brugada syndrome, Jervell and Lange- Nielsen syndrome, Romano-Ward syndrome, Andersen-Tawil syndrome or Timothy's syndrome

    • Subject has had recent (<2 months) acute coronary syndrome

    • Subject has had recent (<2 months) revascularization

    • Subject has a pending cardiac transplant or revascularization

    • Subject has severe stenotic valvular heart disease

    • Subject has severe pulmonary (forced expiratory volume in 1 s < 1 L) hepatic or renal (plasma creatinine > 0.2 mmol/L) disease

    • Subject is participating in another study that may affect the results of this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Antwerpen Belgium
    2 Kiel Germany
    3 Munich Germany
    4 Tubingen Germany
    5 Leeds United Kingdom

    Sponsors and Collaborators

    • Medtronic BRC

    Investigators

    • Study Chair: DECIDE HF Team, Medtronic BRC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic BRC
    ClinicalTrials.gov Identifier:
    NCT00949676
    Other Study ID Numbers:
    • DECIDE-HF
    First Posted:
    Jul 30, 2009
    Last Update Posted:
    Sep 23, 2013
    Last Verified:
    Sep 1, 2013
    Additional relevant MeSH terms:
    Heart Failure
    Heart Failure, Systolic

    Study Results

    No Results Posted as of Sep 23, 2013