Heart Failure With Preserved Ejection FractionGALILEO-HFpEFNCT04239807
3-Month Home-based Training With Whole Body Vibration (WBV) Device in Patients With Heart Failure and Preserved Ejection Fraction (GALILEO-HFpEF-HOME) (GALILEOHOME)
A study testing Group 1 GALILEO WBV in people with Heart Failure With Preserved Ejection Fraction, run by Klinikum der Universität Köln.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Group 1 GALILEO WBV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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)
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- 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)
About this study
Official title: 3-Month Home-based Training With Whole Body Vibration Device in Patients With Heart Failure and Preserved Ejection Fraction (GALILEO-HFpEF-HOME)
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.
Read the 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
- Being tested
- Group 1 GALILEO WBV, Group 2 Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 GALILEO WBVDevice
3 month home based WBV training
Group 2 ControlOther
Training on the floor without WBV
| Study group | Role | What they receive |
|---|---|---|
| Group 1 WBV - training with wbv | Experimental | 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 Receives: Device: Group 1 GALILEO WBV; Other: Group 2 Control |
| Group 2 Control - training without WBV | Other | 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 Receives: Device: Group 1 GALILEO WBV; Other: Group 2 Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Oxygen consumption
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Mar 2020 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum der Universität Köln
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung
- Responsible party
- Principal investigator, Felix Gerhardt, Klinikum der Universität Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239807
- Sponsor's protocol ID
- GALILEO-HFpEF-Home
- Acronym
- GALILEO-HFpEF
- Status last verified
- Jan 2020
- First submitted
- 11 Nov 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-Month Home-based Training With Whole Body Vibration Device in Patients With Heart Failure and Preserved Ejection Fraction (GALILEO-HFpEF-HOME)
- ClinicalTrials.gov ID
- NCT04239807
- Acronym / sponsor ID
- GALILEO-HFpEF / GALILEO-HFpEF-Home
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Klinikum der Universität KölnUniversity, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1 WBV - training with wbv | Experimental | Device: Group 1 GALILEO WBV, Other: Group 2 ControlScreening (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 |
| Group 2 Control - training without WBV | Other | Device: Group 1 GALILEO WBV, Other: Group 2 ControlScreening (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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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%
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1 GALILEO WBV3 month home based WBV training | Device | Group 1 WBV - training with wbv, Group 2 Control - training without WBV |
| Group 2 ControlTraining on the floor without WBV | Other | Group 1 WBV - training with wbv, Group 2 Control - training without WBV |
Primary outcome
Change in Peak Oxygen consumption
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 GALILEO WBV in people with Heart Failure With Preserved Ejection Fraction, run by Klinikum der Universität Köln.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Oxygen consumption (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.