Clinical trial NCT04940312: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Heart Failure, Diastolic
Keywords: Heart failure with preserved ejection fraction (HFpEF)
Activity coaching
Smartphone App
Systems Medicine
Clinical Epidemiology
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Bayer
name: McRoberts B.V.
name: Umana Medical Technologies Ltd.
name: International Business Machines (IBM)
First posted: 2021-06-25
Enrollment: 193
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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

Primary outcomes:
measure: Average daily step count (all groups)
timeFrame: 12 weeks
Secondary outcomes:
measure: Difference in E/E' ratio (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in left ventricular ejection fraction (LVEF) from baseline to 12-week follow-up (V4)
timeFrame: 12 weeks
measure: Difference in quality of life (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in heart rate variability (HRV) (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in peak VO2 (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Change in daily non-sedentary daytime activity from baseline to 12-week follow-up
timeFrame: 12 weeks
measure: Difference in gait speed (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in NT-proBNP from baseline to 12-week follow-up
timeFrame: 12 weeks
measure: Difference in FEV1 (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in the augmentation index (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Correlations of gait speed
timeFrame: 12 weeks
measure: Difference in METs (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in daily step count between the intervention groups (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
Other outcomes:
measure: Difference in biomarkers of autonomic function (change from baseline to 6-week follow-up)
timeFrame: 6 weeks
measure: Difference in biomarkers of autonomic function (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in biomarkers of heart failure (change from baseline to 6-week follow-up)
timeFrame: 6 weeks
measure: Difference in biomarkers of heart failure (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in biomarkers of cardio-vascular diseases (change from baseline to 6-week follow-up)
timeFrame: 6 weeks
measure: Difference in biomarkers of cardio-vascular diseases (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in biomarkers of metabolic diseases (change from baseline to 6-week follow-up)
timeFrame: 6 weeks
measure: Difference in biomarkers of metabolic diseases (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in biomarkers of renal diseases (change from baseline to 6-week follow-up)
timeFrame: 6 weeks
measure: Difference in biomarkers of renal diseases (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in biomarkers of cancer (change from baseline to 6-week follow-up)
timeFrame: 6 weeks
measure: Difference in biomarkers of cancer (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in biomarkers of pulmonary diseases (change from baseline to 6-week follow-up)
timeFrame: 6 weeks
measure: Difference in biomarkers of pulmonary diseases (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in biomarkers of inflammation (change from baseline to 6-week follow-up)
timeFrame: 6 weeks
measure: Difference in biomarkers of inflammation (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in biomarkers of immunity (change from baseline to 6-week follow-up)
timeFrame: 6 weeks
measure: Difference in biomarkers of immunity (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in biomarkers of oxidative stress (change from baseline to 6-week follow-up)
timeFrame: 6 weeks
measure: Difference in biomarkers of oxidative stress (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in biomarkers of hypercoagulability (change from baseline to 6-week follow-up)
timeFrame: 6 weeks
measure: Difference in biomarkers of hypercoagulability (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in biomarkers of vascular/endothelial function (change from baseline to 6-week follow-up)
timeFrame: 6 weeks
measure: Difference in biomarkers of vascular/endothelial function (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in biomarkers of carotid atherosclerosis (change from baseline to 6-week follow-up)
timeFrame: 6 weeks
measure: Difference in biomarkers of carotid atherosclerosis (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in biomarkers of methylation (change from baseline to 6-week follow-up)
timeFrame: 6 weeks
measure: Difference in biomarkers of methylation (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in anthropometrics (change from baseline to 6-week follow-up)
timeFrame: 6 weeks
measure: Difference in anthropometrics (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in biomarkers of psychosomatic diseases (change from baseline to 12-week follow-up)
timeFrame: 12 weeks
measure: Difference in biomarkers of physical activity
timeFrame: 12 weeks
measure: Difference in biomarkers of sedentary daytime activities
timeFrame: 12 weeks
measure: Differences in accelerometry
timeFrame: 12 weeks
measure: Evaluation of compliance of study participants with the mobile devices
timeFrame: 12 weeks
measure: Evaluation of functionality of the mobile devices
timeFrame: 12 weeks
measure: Evaluation of realibility of the mobile devices
timeFrame: 12 weeks
Locations:
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenberg-University Mainz
state: Rhineland-Palatinate
Study officials:
affiliation: University Medical Center Mainz
name: Philipp Wild, Univ.-Prof. Dr. med., MSc
role: PRINCIPAL_INVESTIGATOR
References: