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THERAPEUTIC EXPERTISE

Solutions for Cardiovascular Research

The burden of physical symptoms in cardiovascular conditions such as heart failure is significant and limits patients’ daily functioning, so much so that regulatory agencies have emphasized the need to include physical function as key efficacy endpoints. Digital health technologies provide clinically meaningful insights into patient functioning to improve treatments and prevention programs to reduce the burden of this large, unmet health need.

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Opportunities with DHTs

  • Direct measures of real-world function
  • Demonstrate patient-centric benefits
  • Complement PRO-based evidence
  • Continuous, objective, low-burden data collection

Indications Where DHTs Have Been Included in Clinical Development

  • Chronic Heart Failure
  • Congestive Heart Failure
  • Congenital Heart Disease
  • Hypertrophic Cardiomyopathy
  • Tricuspid Valve Disease

Selected Digital Endpoints for Cardiovascular Research

Physical Activity

  • Moderate to Vigorous Physical Activity (MVPA)
  • Non-Sedentary Time
  • Step Count
  • Real-World 6-Minute Peak Activity

Gait & Mobility

  • Gait Speed / Cadence
  • Real-World 6-Minute Walk Distance
  • Distance

Sleep

  • Wake After Sleep Onset (WASO)
  • Total Sleep Time
  • Sleep Efficiency
  • Sleep Onset Latency

Vital Signs

  • Moderate to Vigorous Physical Activity (MVPA)
  • Non-Sedentary Time
  • Daily Total Activity Counts
  • Walking (step count, peak cadence, walking speed)
Physical Activity
  • Moderate to Vigorous Physical Activity (MVPA)
  • Non-Sedentary Time
  • Step Count
  • Real-World 6-Minute Peak Activity
Gait & Mobility
  • Gait Speed / Cadence
  • Real-World 6-Minute Walk Distance
  • Distance
Sleep
  • Wake After Sleep Onset (WASO)
  • Total Sleep Time
  • Sleep Efficiency
  • Sleep Onset Latency
Vital Signs
  • Moderate to Vigorous Physical Activity (MVPA)
  • Non-Sedentary Time
  • Daily Total Activity Counts
  • Walking (step count, peak cadence, walking speed)

Heart Failure Digital Endpoint Guide

To learn more about opportunities with wearable digital health technologies in Heart Failure clinical trials, download our full guide.

Download the Guide

Functional Assessments

Physical symptoms of cardiovascular diseases are so debilitating and incapacitating that persons with heart failure value symptom stabilization or improvement of physical functioning, dyspnea, and fatigue over conventional outcomes of hospitalization and mortality. Traditionally, these concepts of interest were only assessed indirectly by in-clinic performance assessment, clinician-reported outcomes, or patient-reported outcomes, leaving gaps in our understanding of patient functioning.

Wearables and sensor-based DHTs provide these patient-centric outcomes continuously and remotely, reducing the burden of trial participation and the probability of trial success by enabling the capture of more sensitive measures of real-world function.

View Digital Outcomes and Biomarkers

Key Features and Benefits

  • Capture physical and physiological measures in a single platform
  • FDA cleared, medical-grade wearables
  • Low-burden, passive, remote data collection and transfer
  • Participant adherence monitoring

Patient-Focused Digital Measures Reports

Access our Cardiology digital measure reports inspired by the FDA’s Patient-Focused Drug Development (PFDD) initiative, leveraging information from Voice of the Patient summaries to highlight how digital health technologies can help measure symptoms that are meaningful to patients.

Experience in Cardiology Trials

31
Trials
1084
Sites
28
Countries
5442
Participants

Let’s Connect

Have questions or need assistance? Our team is here to help. Learn more about how Ametris’s innovative solutions can support your research and patient care goals.

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