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

Heart Failure With Preserved Ejection Fraction Clinical Trial

— 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04239807
• Other study ID #: GALILEO-HFpEF-Home
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2020
• Source: Klinikum der Universität Köln
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

Device:
• Group 1 GALILEO WBV
3 month home based WBV training

Other:
• Group 2 Control
Training on the floor without WBV

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum der Universität Köln	Deutsche Stiftung für Herzforschung

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak Oxygen consumption		3 months