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

Heart Failure Clinical Trial

Official title:

A Noninterventional, Single-Center Feasibility Study to Evaluate Longitudinal Measures of Heart Failure Risk Using the Pyxida System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646056
• Other study ID #: PRO-001-001
• Status: Recruiting
• Start date: October 28, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2022
• Source: Prolaio
• Contact: Jay Edelberg, MD PhD
• Phone: 650 646 5609
• Email: info[@]prolaio.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Heart Failure
• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy

Intervention

Device:
• Software
Observation only

Locations

Country	Name	City	State
United States	Research Center	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Prolaio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To evaluate the relationship between in-clinic and ambulatory measures using the Pyxida System		14 days
Primary	Percentage of complete daily datasets transmitted to the Pyxida System database at the end of the monitoring period		14 days
Secondary	To evaluate subject compliance and experience using the Pyxida System		14 days