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

Completed

• Conditions: Left Ventricular Hypertrophy; Cardiomyopathy, Hypertrophic; Heart Failure
• Interventions: Device: Software

• Registration Number: NCT05646056
• Lead Sponsor: Prolaio

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-28
• Study First Submitted: 2022-11-23
• Study First Submitted QC: 2022-12-02
• Study First Posted: 2022-12-12
• Primary Completion: 2024-09-18
• Study Completion: 2024-09-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Asymptomatic subjects with a history of HF	Software	-
Healthy subjects	Software	-
Asymptomatic left ventricular hypertrophy	Software	-
Subjects with a history of hypertrophic cardiomyopathy NYHA Class I, II	Software	-

Primary Outcome Measures

Name	Time	Method
To evaluate the ability of the Pyxida System to collect measurements of heart failure (HF) risk	14 days	Percentage of complete daily datasets transmitted to the Pyxida System database at the end of the monitoring period

Secondary Outcome Measures

Name	Time	Method
To evaluate subject compliance and experience using the Pyxida System	14 days	Outcomes of subject post-study survey

Trial Locations

Locations (1)

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States