MyoMobile Study: App-based Activity Coaching in Patients with Heart Failure and Preserved Ejectio… (NCT04940312) | Clinical Trial Compass
CompletedNot Applicable
MyoMobile Study: App-based Activity Coaching in Patients with Heart Failure and Preserved Ejection Fraction
Germany193 participantsStarted 2020-11-11
Plain-language 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.
Who can participate
Age range45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…