Evaluating A Mobile Health Monitoring Platform For Capturing Patient-centered Outcomes Among Heart Failure Patients

Overview

About this study

The Food and Drug Administration (FDA) recognizes the importance of developing patient-centric endpoints that are relevant to patients beyond mortality and hospitalizations. Patients with HF have reduced function capacity and quality of life (QoL) and hence it is imperative to explore interventions that impact endpoints that directly measure how a patient feels or functions on a daily basis. Recently, new mobile health technologies have emerged as clinical tools and offer an opportunity to overcome these challenges in measuring functional capacity and recording symptoms. These technologies are able to capture and integrate data from disparate sources from individual patients reflecting their functional status and symptomatology. These data can potentially serve as surrogate endpoints for approval of new HF therapies. In this study, the investigators will test the feasibility of a novel mobile health monitoring platform to capture patients' physiology, functional capacity and assessment of quality of life.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: -Age 21 to 85 years at signing of informed consent. -History of chronic heart failure, defined as requiring a pharmacologic treatment for heart failure for a minimum of 30 days -Diagnosis of heart failure. -NYHA class II to class III at most recent screening assessment. -Onboarding within 14 days after hospitalization with primary reason of heart failure or emergency department admission with primary reason of heart failure. -History of (within the past 6 months) or current use of diuretics Exclusion Criteria: -Acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, unstable angina) stroke, or transient ischemic attack, major cardiac surgery, percutaneous coronary intervention, or valvuloplasty within the 30 days prior to randomization. -Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) more than180 mm Hg or diastolic BP (DBP) more than 110 mm Hg. -Untreated severe ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation). -Symptomatic bradycardia or second or third-degree heart block without a pacemaker Other Medical Conditions -Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years -Hospitalization for any reason other than heart failure within the 30 days prior to randomization -Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73 m2 or receiving dialysis at screening.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Jacksonville, Fla. Mayo Clinic principal investigator Christopher McLeod, M.B., Ch.B., Ph.D.	Closed for enrollment
Rochester, Minn. Mayo Clinic principal investigator Molly Jeffery, Ph.D.	Closed for enrollment

Mayo Clinic Location

Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Christopher McLeod, M.B., Ch.B., Ph.D.

Closed for enrollment

Rochester, Minn.

Mayo Clinic principal investigator

Molly Jeffery, Ph.D.

Closed for enrollment

More information

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