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3-Month Home-based Training With Whole Body Vibration (WBV) Device in Patients With Heart Failure and Preserved Ejection Fraction (GALILEO-HFpEF-HOME) (GALILEOHOME) (GALILEO-HFpEF)

Primary Purpose

Heart Failure With Preserved Ejection Fraction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group 1 GALILEO WBV
Group 2 Control
Sponsored by
Klinikum der Universität Köln
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

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

Inclusion Criteria:

  • stable (≥ 2 months) symptomatic heart failure with preserved ejection fraction
  • elevated NTproBNP (>= 125 ng/l)
  • NYHA-WHO/FC II or III
  • peakVO2 <25 mL/kg/min
  • LVEF ≥50%

  • E/e' >15 or 15 ≥E/e' >8 and one of the following:

    • NT-proBNP >220 ng/L ar atrial fibrillation

  • age ≥18 years
  • symptoms and heart insufficiency medication according to current guidelines and stable for at least 4 weeks
  • general mental and physical ability to perform the study
  • ability to understand and sign informed consent of the study

Exclusion Criteria:

  • non cardial origin of symptoms similiar to heart insufficiency
  • normal NTproBNP (< 125 ng/l)
  • relevant chronic obstructive lungdisease ≥ GOLD Stadium III
  • significant anemia (hemoglobin < 11 mg/dl)
  • relevant renal insuffciency (eGFR <30 mL/min/1.73 m2 indexed to BSA)
  • significant peripheral artery disease (Fontaine ≥ IIb)
  • muscolosclettal disease compromising ability to exercise
  • specific cardiomyopathy (e.g.. amyloidosis)
  • hemodynamic relevant, not repaired valvular diseases
  • relevant coronary artery disease (angina pectoris ≥ CCS II or positive functional test, myocardial infarction or CABG within last 3 months)
  • unability to perform exercises (mental, physical) or unability to give infromation requested (diary, quality of life)
  • uncontrolled arterial hypertension (≥140/90 mmHg or ≥160/100 mmHg with 3 antihypertensive substances) or resting heart rate ≥ 100 b.p.m.)
  • unabilty to perform training within time planned (planned vacation)
  • Rehabilitation program or planned new training program 2 months before screeninig or within the studyphase
  • pregnancy
  • acute thrombosis (within the last 3 months)
  • Implants in hib, knee or spine (TEP)
  • new fracture (within 3 months)
  • not feasable to perform trianing (NYHA IV, immobility)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Group 1 WBV - training with wbv

    Group 2 Control - training without WBV

    Arm Description

    Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion critera Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv). Introduction Week -1(-7d-d1): All subjects will receive introduction in their training Month 1: Day 1: From this day subjects are supposed to start their training accoridng to protocol Day 2: Telephone Visit Day 5: Telephone Visit Day 7: Telephone Visit Day 10: Telephone Visit Day 13: Telephone Visit Day 20: Telephone Visit Day 27: Telephone Visit Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training Month 2: Week 5, Day 34: Week 6, Day 41: Week 7, Day 48: Week 8, Day 55: Month 3: Week 9, Day 62: Week 10, Day 69: Week 11, Day 76: Week 12, Day 83: Final Visit

    Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion critera Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv). Introduction Week -1(-7d-d1): All subjects will receive introduction in their training Month 1: Day 1: From this day subjects are supposed to start their training accoridng to protocol Day 2: Telephone Visit Day 5: Telephone Visit Day 7: Telephone Visit Day 10: Telephone Visit Day 13: Telephone Visit Day 20: Telephone Visit Day 27: Telephone Visit Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training Month 2: Week 5, Day 34: Week 6, Day 41: Week 7, Day 48: Week 8, Day 55: Month 3: Week 9, Day 62: Week 10, Day 69: Week 11, Day 76: Week 12, Day 83: Final Visit

    Outcomes

    Primary Outcome Measures

    Change in Peak Oxygen consumption

    Secondary Outcome Measures

    Full Information

    First Posted
    November 11, 2019
    Last Updated
    January 20, 2020
    Sponsor
    Klinikum der Universität Köln
    Collaborators
    Deutsche Stiftung für Herzforschung
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04239807
    Brief Title
    3-Month Home-based Training With Whole Body Vibration (WBV) Device in Patients With Heart Failure and Preserved Ejection Fraction (GALILEO-HFpEF-HOME) (GALILEOHOME)
    Acronym
    GALILEO-HFpEF
    Official Title
    3-Month Home-based Training With Whole Body Vibration Device in Patients With Heart Failure and Preserved Ejection Fraction (GALILEO-HFpEF-HOME)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2020 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    June 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Klinikum der Universität Köln
    Collaborators
    Deutsche Stiftung für Herzforschung

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    In order to evaluate Long-term effects of whole Body Vibration (wbv) in patients with HFpEF patients will get a training device to use at home for 3 months. Patients in the Intervention group will be introduced in the training program on the wbv-device in the study center 3-4 times and baseline parameters will be collected before start of the home based training. Patients randomized into the placebo arm be introduced into the training program according to the interventional arm but not performing the exercises on the wbv-device but on the floor.
    Detailed Description
    Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion criteria Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv). Introduction Week -1(-7d-d1): All subjects will receive introduction in their training Month 1: Day 1: From this day subjects are supposed to start their training according to protocol Day 2: Telephone Visit Day 5: Telephone Visit Day 7: Telephone Visit Day 10: Telephone Visit Day 13: Telephone Visit Day 20: Telephone Visit Day 27: Telephone Visit Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training Month 2: Week 5, Day 34: Week 6, Day 41: Week 7, Day 48: Week 8, Day 55: Month 3: Week 9, Day 62: Week 10, Day 69: Week 11, Day 76: Week 12, Day 83: Final Visit

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure With Preserved Ejection Fraction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion critera Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv). Introduction Week -1(-7d-d1): All subjects will receive introduction in their training Month 1: Day 1: From this day subjects are supposed to start their training accoridng to protocol Day 2: Telephone Visit Day 5: Telephone Visit Day 7: Telephone Visit Day 10: Telephone Visit Day 13: Telephone Visit Day 20: Telephone Visit Day 27: Telephone Visit Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training Month 2: Week 5, Day 34: Week 6, Day 41: Week 7, Day 48: Week 8, Day 55: Month 3: Week 9, Day 62: Week 10, Day 69: Week 11, Day 76: Week 12, Day 83: Final Visit
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1 WBV - training with wbv
    Arm Type
    Experimental
    Arm Description
    Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion critera Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv). Introduction Week -1(-7d-d1): All subjects will receive introduction in their training Month 1: Day 1: From this day subjects are supposed to start their training accoridng to protocol Day 2: Telephone Visit Day 5: Telephone Visit Day 7: Telephone Visit Day 10: Telephone Visit Day 13: Telephone Visit Day 20: Telephone Visit Day 27: Telephone Visit Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training Month 2: Week 5, Day 34: Week 6, Day 41: Week 7, Day 48: Week 8, Day 55: Month 3: Week 9, Day 62: Week 10, Day 69: Week 11, Day 76: Week 12, Day 83: Final Visit
    Arm Title
    Group 2 Control - training without WBV
    Arm Type
    Other
    Arm Description
    Screening (day -21 until day -7): Subjects will be evaluated according to In- and Exclusion critera Randomization (day -7): Subjects will be randomized to either Intervention Group (training on wbv platform) or non-Intervention Group (training without wbv). Introduction Week -1(-7d-d1): All subjects will receive introduction in their training Month 1: Day 1: From this day subjects are supposed to start their training accoridng to protocol Day 2: Telephone Visit Day 5: Telephone Visit Day 7: Telephone Visit Day 10: Telephone Visit Day 13: Telephone Visit Day 20: Telephone Visit Day 27: Telephone Visit Week 4, Day 28: Study center Visit: 6MWD, QoL-Questionnaire, AEs, re-training Month 2: Week 5, Day 34: Week 6, Day 41: Week 7, Day 48: Week 8, Day 55: Month 3: Week 9, Day 62: Week 10, Day 69: Week 11, Day 76: Week 12, Day 83: Final Visit
    Intervention Type
    Device
    Intervention Name(s)
    Group 1 GALILEO WBV
    Intervention Description
    3 month home based WBV training
    Intervention Type
    Other
    Intervention Name(s)
    Group 2 Control
    Intervention Description
    Training on the floor without WBV
    Primary Outcome Measure Information:
    Title
    Change in Peak Oxygen consumption
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: stable (≥ 2 months) symptomatic heart failure with preserved ejection fraction elevated NTproBNP (>= 125 ng/l) NYHA-WHO/FC II or III peakVO2 <25 mL/kg/min LVEF ≥50% E/e' >15 or 15 ≥E/e' >8 and one of the following: • NT-proBNP >220 ng/L ar atrial fibrillation age ≥18 years symptoms and heart insufficiency medication according to current guidelines and stable for at least 4 weeks general mental and physical ability to perform the study ability to understand and sign informed consent of the study Exclusion Criteria: non cardial origin of symptoms similiar to heart insufficiency normal NTproBNP (< 125 ng/l) relevant chronic obstructive lungdisease ≥ GOLD Stadium III significant anemia (hemoglobin < 11 mg/dl) relevant renal insuffciency (eGFR <30 mL/min/1.73 m2 indexed to BSA) significant peripheral artery disease (Fontaine ≥ IIb) muscolosclettal disease compromising ability to exercise specific cardiomyopathy (e.g.. amyloidosis) hemodynamic relevant, not repaired valvular diseases relevant coronary artery disease (angina pectoris ≥ CCS II or positive functional test, myocardial infarction or CABG within last 3 months) unability to perform exercises (mental, physical) or unability to give infromation requested (diary, quality of life) uncontrolled arterial hypertension (≥140/90 mmHg or ≥160/100 mmHg with 3 antihypertensive substances) or resting heart rate ≥ 100 b.p.m.) unabilty to perform training within time planned (planned vacation) Rehabilitation program or planned new training program 2 months before screeninig or within the studyphase pregnancy acute thrombosis (within the last 3 months) Implants in hib, knee or spine (TEP) new fracture (within 3 months) not feasable to perform trianing (NYHA IV, immobility)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    3-Month Home-based Training With Whole Body Vibration (WBV) Device in Patients With Heart Failure and Preserved Ejection Fraction (GALILEO-HFpEF-HOME) (GALILEOHOME)

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