A Noninterventional, Single-Center Feasibility Study to Evaluate Measures of Heart Failure Risk

Prolaio

Status: Completed

Conditions: Left Ventricular Hypertrophy; Cardiomyopathy, Hypertrophic; Heart Failure

Treatments: Device: Software

Study type: Observational

Funder types: Industry

Identifiers

NCT05646056

PRO-001-001

Details and patient eligibility

About

This is a non-invasive/observational study in healthy and mild HF subjects utilizing clinical and ambulatory measurements to improve detection, monitoring, and management of HF risks.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Cohort 2: Confirmed medical history of LVH based on American College of Cardiology (ACC)/American Heart Association (AHA) guidelines and NYHA Class I at screening
• Cohort 3: Confirmed medical history of HF consistent with current ACC/AHA guidelines and NYHA Class I at screening
• Cohort 4: Confirmed medical history of HCM consistent with ACC/AHA guidelines and NYHA Class I or II at screening

Key Exclusion Criteria:

• Active neurological disorder, such as uncontrolled seizure disorder.
• Current diagnosis of cancer or other known acute chronic infection, such as hepatitis B or hepatitis C, by medical history or an active infection requiring interventional therapy at screening.
• Shortness of breath, fatigue, heart palpitations, pain, or other limitations of physical activity

Trial design

82 participants in 4 patient groups

Healthy subjects

Treatment:

Device: Software

Asymptomatic subjects with a history of left ventricular hypertrophy (LVH) and NYHA Class I

Treatment:

Device: Software

Asymptomatic subjects with a history of heart failure (HF) and NYHA Class I

Treatment:

Device: Software

Subjects with a history of hypertrophic cardiomyopathy (HCM) and NYHA Class I, II

Treatment:

Device: Software