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

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ClinicalTrials.gov Identifier: NCT04940312
Recruitment Status : Recruiting
First Posted : June 25, 2021
Last Update Posted : June 29, 2021
Sponsor:
Collaborators:
Bayer
McRoberts B.V.
Umana Medical Technologies Ltd.
International Business Machines (IBM)
Information provided by (Responsible Party):
Philipp Wild, MD, MSc, University Medical Center Mainz

Tracking Information
First Submitted Date February 3, 2021
First Posted Date June 25, 2021
Last Update Posted Date June 29, 2021
Actual Study Start Date November 11, 2020
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 17, 2021)
Average daily step count (all groups) [ Time Frame: 12 weeks ]
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 17, 2021)
  • Difference in E/E' ratio (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in E/E' ratio (change from baseline (V1) to 12-week follow-up (V4))
  • Difference in left ventricular ejection fraction (LVEF) from baseline to 12-week follow-up (V4) [ Time Frame: 12 weeks ]
    Difference in LVEF (systolic function) from baseline to 12-week follow-up
  • Difference in quality of life (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in quality of life from baseline to 12-week follow-up (measured with The Kansas City Cardiomyopathy Questionnaire (KCCQ))
  • Difference in heart rate variability (HRV) (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in HRV from baseline to 12-week follow-up (measured with 24-hour Holter ECG)
  • Difference in peak VO2 (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in peak VO2 from baseline to 12-week follow-up (cardiopulmonary exercise testing)
  • Change in daily non-sedentary daytime activity from baseline to 12-week follow-up [ Time Frame: 12 weeks ]
    Change in daily non-sedentary daytime activity from baseline to 12-week follow-up (composite measure of movement and locomotion as measured by the Dynaport MoveMonitor) (V4)
  • Difference in gait speed (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Change in gait speed from baseline to 12-week follow-up
  • Difference in NT-proBNP from baseline to 12-week follow-up [ Time Frame: 12 weeks ]
    Difference in the serum concentration of N-terminal brain natriuretic peptide (NT-proBNP) from baseline to 12-week follow-up
  • Difference in FEV1 (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in forced expiratory volume in one second (FEV1) from baseline to 12-week follow-up
  • Difference in the augmentation index (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in the augmentation index from baseline to 12-week follow-up. The augmentation index is an indicator of arterial stiffness; higher values indicate a worse outcome
  • Correlations of gait speed [ Time Frame: 12 weeks ]
    Correlations of gait speed during an intermittent supervised test to data assessed in patients' home environment
  • Difference in METs (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Change in metabolic equivalents (METs) from baseline to 12-week follow-up
  • Difference in daily step count between the intervention groups (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in daily step count from baseline to end of study (comparing the two intervention groups only)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 17, 2021)
  • Difference in biomarkers of autonomic function (change from baseline to 6-week follow-up) [ Time Frame: 6 weeks ]
    Difference in biomarkers of autonomic function from baseline to 6-week follow-up (e.g. heart rate variability)
  • Difference in biomarkers of autonomic function (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in biomarkers of autonomic function from baseline to 12-week follow-up (e.g. heart rate variability)
  • Difference in biomarkers of heart failure (change from baseline to 6-week follow-up) [ Time Frame: 6 weeks ]
    Difference in biomarkers of heart failure from baseline to 6-week follow-up (e.g., NT-proBNP)
  • Difference in biomarkers of heart failure (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in biomarkers of heart failure from baseline to 12-week follow-up (e.g., NT-proBNP)
  • Difference in biomarkers of cardio-vascular diseases (change from baseline to 6-week follow-up) [ Time Frame: 6 weeks ]
    Difference in biomarkers of cardiovascular diseases from baseline to 6-week follow-up (e.g., troponin)
  • Difference in biomarkers of cardio-vascular diseases (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in biomarkers of cardiovascular diseases from baseline to 12-week follow-up (e.g., troponin)
  • Difference in biomarkers of metabolic diseases (change from baseline to 6-week follow-up) [ Time Frame: 6 weeks ]
    Difference in biomarkers of metabolic diseases from baseline to 6-week follow-up (e.g., HbA1c)
  • Difference in biomarkers of metabolic diseases (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in biomarkers of metabolic diseases from baseline to 12-week follow-up (e.g., HbA1c)
  • Difference in biomarkers of renal diseases (change from baseline to 6-week follow-up) [ Time Frame: 6 weeks ]
    Difference in biomarkers of renal diseases from baseline to 6-week follow-up (e.g., eGFR)
  • Difference in biomarkers of renal diseases (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in biomarkers of renal diseases from baseline to 12-week follow-up (e.g., eGFR)
  • Difference in biomarkers of cancer (change from baseline to 6-week follow-up) [ Time Frame: 6 weeks ]
    Difference in biomarkers of cancer from baseline to 6-week follow-up (e.g., LDH)
  • Difference in biomarkers of cancer (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in biomarkers of cancer from baseline to 12-week follow-up (e.g., LDH)
  • Difference in biomarkers of pulmonary diseases (change from baseline to 6-week follow-up) [ Time Frame: 6 weeks ]
    Difference in biomarkers of pulmonary diseases from baseline to 6-week follow-up (e.g., FEV1)
  • Difference in biomarkers of pulmonary diseases (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in biomarkers of pulmonary diseases from baseline to 12-week follow-up (e.g., FEV1)
  • Difference in biomarkers of inflammation (change from baseline to 6-week follow-up) [ Time Frame: 6 weeks ]
    Difference in biomarkers of inflammation from baseline to 6-week follow-up (e.g., C-reactive protein)
  • Difference in biomarkers of inflammation (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in biomarkers of inflammation from baseline to 12-week follow-up (e.g., C-reactive protein)
  • Difference in biomarkers of immunity (change from baseline to 6-week follow-up) [ Time Frame: 6 weeks ]
    Difference in biomarkers of immunity from baseline to 6-week follow-up (e.g., leukocytes)
  • Difference in biomarkers of immunity (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in biomarkers of immunity from baseline to 12-week follow-up (e.g., leukocytes)
  • Difference in biomarkers of oxidative stress (change from baseline to 6-week follow-up) [ Time Frame: 6 weeks ]
    Difference in biomarkers of oxidative stress from baseline to 6-week follow-up (e.g., monocytes)
  • Difference in biomarkers of oxidative stress (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in biomarkers of oxidative stress from baseline to 12-week follow-up (e.g., monoytes)
  • Difference in biomarkers of hypercoagulability (change from baseline to 6-week follow-up) [ Time Frame: 6 weeks ]
    Difference in biomarkers of hypercoagulability from baseline to 6-week follow-up (e.g. mean platelet volume)
  • Difference in biomarkers of hypercoagulability (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in biomarkers of hypercoagulability from baseline to 12-week follow-up (e.g., mean platelet volume)
  • Difference in biomarkers of vascular/endothelial function (change from baseline to 6-week follow-up) [ Time Frame: 6 weeks ]
    Difference in biomarkers of vascular/endothelial function from baseline to 6-week follow-up (e.g. pulse-wave velocity)
  • Difference in biomarkers of vascular/endothelial function (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in biomarkers of vascular/endothelial function from baseline to 12-week follow-up (e.g. pulse-wave velocity)
  • Difference in biomarkers of carotid atherosclerosis (change from baseline to 6-week follow-up) [ Time Frame: 6 weeks ]
    Difference in biomarkers of carotid atherosclerosis from baseline to 6-week follow-up (e.g., intima-media-thickness)
  • Difference in biomarkers of carotid atherosclerosis (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in biomarkers of carotid atherosclerosis from baseline to 12-week follow-up (e.g., intima-media-thickness)
  • Difference in biomarkers of methylation (change from baseline to 6-week follow-up) [ Time Frame: 6 weeks ]
    Difference in biomarkers of methylation from baseline to 6-week follow-up (e.g., CpG methylation)
  • Difference in biomarkers of methylation (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in biomarkers of methylation from baseline to 12-week follow-up (e.g., CpG methylation)
  • Difference in anthropometrics (change from baseline to 6-week follow-up) [ Time Frame: 6 weeks ]
    Difference in anthropometrics from baseline to 6-week follow-up (e.g., BMI)
  • Difference in anthropometrics (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in anthropometrics from baseline to 12-week follow-up (e.g., BMI)
  • Difference in biomarkers of psychosomatic diseases (change from baseline to 12-week follow-up) [ Time Frame: 12 weeks ]
    Difference in biomarkers of psychosomatic diseases from baseline to 12-week follow-up (e.g, PHQ-9)
  • Difference in biomarkers of physical activity [ Time Frame: 12 weeks ]
    Difference in biomarkers of physical activity (e.g., step count)
  • Difference in biomarkers of sedentary daytime activities [ Time Frame: 12 weeks ]
    Difference in biomarkers of sedentary daytime activities (e.g., sleeping time)
  • Differences in accelerometry [ Time Frame: 12 weeks ]
    Differences in accelerometry (e.g., measured with the Dynaport MoveMonitor)
  • Evaluation of compliance of study participants with the mobile devices [ Time Frame: 12 weeks ]
    Explorative evaluation of compliance as assessed with technical data from the mobile devices (e.g. wearing time) and a qualitative questionnaire on device experience (allowing to evaluate inter alia feasibility and wearability)
  • Evaluation of functionality of the mobile devices [ Time Frame: 12 weeks ]
    Explorative evaluation of device functionality (e.g., as measured by number of data points per observation period)
  • Evaluation of realibility of the mobile devices [ Time Frame: 12 weeks ]
    Explorative evaluation of realibility of mobile device measurements (e.g. by comparing systolic blood pressure measurements between mobile devices and routine measurements)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title MyoMobile Study: App-based Activity Coaching in Patients With Heart Failure and Preserved Ejection Fraction
Official Title A Randomized Study to Investigate the Effects of Individualized App-based Coaching on Physical Activity and Myocardial and Vascular Function of Patients With Heart Failure and Preserved Ejection Fraction Compared to Standard Care
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.
Detailed Description

Heart failure (HF) affects more than 15 million people in Europe and represents the leading cause of hospitalization. The prevalence of HF is increasing, which has been attributed to an ageing population with subsequently higher prevalence of predisposing risk factors (e.g. arterial hypertension, type-2-diabetes, obesity), a better survival, and more effective treatment of precursors (e.g. myocardial infarction). In the community, heart failure with preserved ejection fraction (HFpEF) is the most common HF phenotype. Currently, the benefit of medical therapies is limited to patients with heart failure with reduced ejection fraction (HFrEF) only, whereas no specific medical therapy is currently approved for patients with HFpEF.

In HF patients, physical inactivity and a sedentary lifestyle lead to disease progression and increased mortality, and an increase of physical activity is positively correlated with improved outcome. Guidelines from the Heart Failure Society of America recommend at least 30 minutes of moderate-intensity activity for ≥ 5 days/week (i.e. at least 150 min/week). Unfortunately, exercise recommendations are poorly implemented in daily clinical practice and even patients enrolled in supervised exercise training programs have been reported to show low adherence.

The MyoMobile study has been designed to assess the effect of a 12-week, app-based coaching program on physical activity in patients with HFpEF. Physical activity including daily step count will be assessed by accelerometry and, in addition, a pedometer will be used to measure the daily step count and provide direct feedback to the patient. Accelerometers provide an objective and continuous assessment of physical activity during patients' daily life over longer periods and may therefore reflect the true effect of the activity coaching intervention on physical activity more accurately than intermittent supervised exercise tests such as the six minute walk test. These efforts are complemented by a comprehensive (sub)clinical and molecular characterization of HFpEF patients at baseline and after the follow-up period of 12 weeks. In order to evaluate the potential effect of awareness for physical activity and of surveillance, due to participants wearing a pedometer throughout the study period, two intervention groups will be investigated. This will allow for the effect of an individualized, app-based coaching intervention, compared to standard care in patients with HFpEF, to be deciphered.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

Blood

  • Serum
  • Plasma (EDTA, citrated, heparinized)
  • DNA
  • RNA Urine
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)
Condition
  • Heart Failure
  • Heart Failure, Diastolic
Intervention Behavioral: App-based physical activity coaching
Individualized app-based coaching via a smartphone
Study Groups/Cohorts
  • Usual Care Group
    Individuals with heart failure receiving standard medical care
  • Intervention Group 1 (pedometer-monitoring only)
    Individuals with heart failure receiving a pedometer for measurement of daily step count
  • 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
    Intervention: Behavioral: App-based physical activity coaching
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 17, 2021)
229
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2022
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Philipp Wild, Univ.-Prof. Dr. med., MSc +49 (0) 6131-177163 philipp.wild@unimedizin-mainz.de
Contact: Jürgen Prochaska, Dr. med +49 (0) 6131-172594 juergen.prochaska@unimedizin-mainz.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04940312
Other Study ID Numbers UMCM-2020EPI06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Philipp Wild, MD, MSc, University Medical Center Mainz
Study Sponsor Johannes Gutenberg University Mainz
Collaborators
  • Bayer
  • McRoberts B.V.
  • Umana Medical Technologies Ltd.
  • International Business Machines (IBM)
Investigators
Principal Investigator: Philipp Wild, Univ.-Prof. Dr. med., MSc University Medical Center Mainz
PRS Account Johannes Gutenberg University Mainz
Verification Date June 2021