NCT04239807

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

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

November 11, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2.3 years

First QC Date

November 11, 2019

Last Update Submit

January 20, 2020

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

  • Change in Peak Oxygen consumption

    3 months

Study Arms (2)

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

Device: Group 1 GALILEO WBVOther: 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

Device: Group 1 GALILEO WBVOther: Group 2 Control

Interventions

Group 1 GALILEO WBVDEVICE

3 month home based WBV training

Group 1 WBV - training with wbvGroup 2 Control - training without WBV
Group 2 ControlOTHER

Training on the floor without WBV

Group 1 WBV - training with wbvGroup 2 Control - training without WBV

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Felix Gerhardt, MD

Study Record Dates

First Submitted

November 11, 2019

First Posted

January 27, 2020

Study Start

March 1, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share