MyoMobile Study: App-based Activity Coaching in Patients with Heart Failure and Preserved Ejection Fraction

NCT04940312 | Completed DMC

• 1 other identifier: UMCM-2020EPI06
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 1

Brief Summary

The MyoMobile study is a single-center, randomized, controlled three-armed cohort study with prospective data collection to investigate the effect of a personalized mobile health intervention compared to usual care on the physical activity levels in patients with heart failure and preserved ejection fraction.

Conditions

Heart Failure; Heart Failure, Diastolic

Keywords

Heart failure with preserved ejection fraction (HFpEF); Activity coaching; Smartphone App; Systems Medicine; Clinical Epidemiology

Outcome Measures

Primary Outcomes (1)

• Average daily step count (all groups)

  The primary efficacy endpoint is the change in average daily step count between the baseline phase (mean of data collected during the period prior to randomization) and the end of the intervention (mean of data collected during week 12) comparing standard care to a 12-week individualized app-based activity coaching

  12 weeks

Secondary Outcomes (13)

• Difference in E/E' ratio (change from baseline to 12-week follow-up)

  12 weeks

• Difference in left ventricular ejection fraction (LVEF) from baseline to 12-week follow-up (V4)

  12 weeks

• Difference in quality of life (change from baseline to 12-week follow-up)

  12 weeks

• Difference in heart rate variability (HRV) (change from baseline to 12-week follow-up)

  12 weeks

• Difference in peak VO2 (change from baseline to 12-week follow-up)

  12 weeks

Other Outcomes (37)

• Difference in biomarkers of autonomic function (change from baseline to 6-week follow-up)

  6 weeks

• Difference in biomarkers of autonomic function (change from baseline to 12-week follow-up)

  12 weeks

• Difference in biomarkers of heart failure (change from baseline to 6-week follow-up)

  6 weeks

Study Arms (3)

Usual Care Group

Individuals with heart failure receiving standard medical care

Behavioral: No Intervention: Observational Cohort

Intervention Group 1 (pedometer-monitoring only)

Individuals with heart failure receiving a pedometer for measurement of daily step count

Behavioral: Intervention Group 1

Intervention Group 2 (app-based coaching)

Individuals with heart failure receiving an individualized, app-based physical activity coaching on the basis of pedometer-based assessment of daily step count

Behavioral: App-based physical activity coaching

Interventions

App-based physical activity coaching BEHAVIORAL

Individualized app-based coaching via a smartphone

Intervention Group 2 (app-based coaching)

No Intervention: Observational Cohort BEHAVIORAL

no Intervention

Usual Care Group

Intervention Group 1 BEHAVIORAL

pedometer-based tracking of physical activity

Intervention Group 1 (pedometer-monitoring only)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with an age of 45 years or older with a diagnosis of heart failure with preserved ejection fraction (HFpEF)

You may qualify if:

• Age ≥ 45 years
• Diagnosis of HFpEF
• LVEF \> 40% by any imaging modality at screening within 4 months prior to study entry
• Current HF symptoms as defined as presence of dyspnea according to New York Heart Association \[NYHA\] functional class I to III at screening visit
• Stable HF treatment for at least 4 weeks prior to screening
• At least one of the following 3 criteria need to be fulfilled: (1) NT-proBNP ≥ 300pg/ml; (2) Hospitalization for HF within the past 12 months; (3) Symptom(s) of HF requiring treatment with diuretic(s) for at least 30 days prior to screening visit
• Wearing time of the physical activity monitor for at least 4 days during the baseline assessment
• Average daily step count during baseline assessment ≥ 1,000 steps per day and \< 10,000 steps per day

You may not qualify if:

• Acute decompensated HF requiring augmented therapy with diuretic agents, vasodilator agents, and/or inotropic drugs
• Participants who are non-ambulatory managed or use mobility assistive devices such as motorized devices or wheelchairs
• Acute coronary syndrome (including myocardial infarction), cardiac surgery, other major cardiovascular surgery or urgent percutaneous coronary intervention (PCI) within 3 months prior to visit 1 or an elective PCI within 30 days after study enrolment
• Probable alternative diagnoses that in the opinion of the investigator account for the patient's HF symptoms (i.e., dyspnea, fatigue)
• Participants with physical activity impairment primarily due to conditions other than HF such as:
• Participants unwilling or unable to wear or to operate study measurement devices for the phases required
• Exertional angina
• Inflammatory or degenerative joint disease
• Peripheral vascular disease
• Neurologic disease affecting activity or mobility (e.g. peripheral neuropathy)
• Foot ulcer (e.g. diabetic foot syndrome)
• Prosthetic limbs
• Current chemotherapy and/or radiation therapy for treatment of active cancer
• Medical or psychological conditions that would jeopardize an adequate and orderly conduct or completion of the study

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• Bayer: collaborator
• McRoberts B.V.: collaborator
• Umana Medical Technologies Ltd.: collaborator
• International Business Machines (IBM): collaborator

Study Sites (1)

University Medical Center of the Johannes Gutenberg-University Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Publications (1)

• Zeid S, Prochaska JH, Schuch A, Trobs SO, Schulz A, Munzel T, Pies T, Dinh W, Michal M, Simon P, Wild PS. Personalized app-based coaching for improving physical activity in heart failure with preserved ejection fraction patients compared with standard care: rationale and design of the MyoMobile Study. Eur Heart J Digit Health. 2025 Jan 30;6(2):298-309. doi: 10.1093/ehjdh/ztae096. eCollection 2025 Mar.

  PMID: 40110212 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood * Serum * Plasma (EDTA, citrated, heparinized) * DNA * RNA Urine

MeSH Terms

Conditions

Heart Failure; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Philipp Wild, Univ.-Prof. Dr. med., MSc

  University Medical Center Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med.

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: June 25, 2021
• Study Start: November 11, 2020
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)