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

December 2, 2022 updated by: Prolaio

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

asymptomatic healthy subjects and subjects with heart failure risk factors and no or moderate symptoms

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy subjects
Device: Software
Observation only
Asymptomatic left ventricular hypertrophy
Device: Software
Observation only
Asymptomatic subjects with a history of HF
Device: Software
Observation only
Subjects with a history of hypertrophic cardiomyopathy NYHA Class I, II
Device: Software
Observation only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of complete daily datasets transmitted to the Pyxida System database at the end of the monitoring period
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate subject compliance and experience using the Pyxida System
Time Frame: 14 days
14 days

Other Outcome Measures

Outcome Measure
Time Frame
To evaluate the relationship between in-clinic and ambulatory measures using the Pyxida System
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prolaio

Investigators

  • Principal Investigator: Michael Koren, MD, Jacksonville Center for Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2022

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

December 2, 2022

First Posted (Estimate)

December 12, 2022

Study Record Updates

Last Update Posted (Estimate)

December 12, 2022

Last Update Submitted That Met QC Criteria

December 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-001-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Software

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe