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Recruiting
NCT05646056
A Noninterventional, Single-Center Feasibility Study to Evaluate Measures of Heart Failure Risk
Conditions: Heart Failure, Cardiomyopathy, Hypertrophic, Left Ventricular Hypertrophy
Sex: All
Ages: 18 Years – N/A
Enrollment: 100
Sponsor: Prolaio
Location: United States
Summary
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.
Eligibility 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 screeningCohort 3: Confirmed medical history of HF consistent with current ACC/AHA guidelines and NYHA Class I at screeningCohort 4: Confirmed medical history of HCM consistent with ACC/AHA guidelines and NYHA Class I or II at screeningKey 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
Source: ClinicalTrials.gov (NCT05646056). StuddyBuddy aggregates publicly available trial information.