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

Last updated: October 22, 2024
Sponsor: Prolaio
Overall Status: Completed

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

Software

Clinical Study ID

NCT05646056
PRO-001-001
  • Ages > 18
  • All Genders

Study 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

Inclusion

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 guidelinesand NYHA Class I at screening

  • Cohort 4: Confirmed medical history of HCM consistent with ACC/AHA guidelines andNYHA Class I or II at screening

Exclusion

Key Exclusion Criteria:

  • Active neurological disorder, such as uncontrolled seizure disorder.

  • Current diagnosis of cancer or other known acute chronic infection, such ashepatitis B or hepatitis C, by medical history or an active infection requiringinterventional therapy at screening.

  • Shortness of breath, fatigue, heart palpitations, pain, or other limitations ofphysical activity

Study Design

Total Participants: 82
Treatment Group(s): 1
Primary Treatment: Software
Phase:
Study Start date:
October 28, 2022
Estimated Completion Date:
September 18, 2024

Connect with a study center

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Research Center

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

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