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)

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Device: Group 1 GALILEO WBV; Other: Group 2 Control

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 WBV - training with wbv; 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 WBV; 3 month home based WBV training; Other: Group 2 Control; Training on the floor without WBV
Other: Group 2 Control - training without WBV; 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 WBV; 3 month home based WBV training; Other: Group 2 Control; Training on the floor without WBV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Peak Oxygen consumption	3 months

Collaborators and Investigators

• Sponsor: Klinikum der Universität Köln
• Collaborators: Deutsche Stiftung für Herzforschung

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: GALILEO-HFpEF-Home

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No