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

NCT05646056 | Completed FDA Device

• 1 other identifier: PRO-001-001
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Cardiomyopathy, Hypertrophic; Left Ventricular Hypertrophy

Outcome Measures

Primary Outcomes (1)

• To evaluate the ability of the Pyxida System to collect measurements of heart failure (HF) risk

  Percentage of complete daily datasets transmitted to the Pyxida System database at the end of the monitoring period

  14 days

Secondary Outcomes (1)

• To evaluate subject compliance and experience using the Pyxida System

  14 days

Other Outcomes (1)

• To evaluate the relationship between in-clinic and ambulatory measures using the Pyxida System

  14 days

Study Arms (4)

Healthy subjects

Device: Software

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

Device: Software

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

Device: Software

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

Device: Software

Interventions

Software DEVICE

Observation only

Asymptomatic subjects with a history of heart failure (HF) and NYHA Class I; Asymptomatic subjects with a history of left ventricular hypertrophy (LVH) and NYHA Class I; Healthy subjects; Subjects with a history of hypertrophic cardiomyopathy (HCM) and NYHA Class I, II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Single-center study of asymptomatic healthy subjects and subjects with HF risk factors and no more than mild to moderate symptoms

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prolaio: lead

Study Sites (1)

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

MeSH Terms

Conditions

Heart Failure; Cardiomyopathy, Hypertrophic; Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Cardiomegaly; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Koren, MD

  Jacksonville Center For Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 12, 2022
• Study Start: October 28, 2022
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

US (1)