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

N/A
Waitlist Available
Led By Michael Koren, MD
Research Sponsored by Prolaio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Hypertrophic Cardiomyopathy
  • Enlarged Heart
  • Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate the ability of the Pyxida System to collect measurements of heart failure (HF) risk
Secondary study objectives
To evaluate subject compliance and experience using the Pyxida System
Other study objectives
To evaluate the relationship between in-clinic and ambulatory measures using the Pyxida System

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Subjects with a history of hypertrophic cardiomyopathy (HCM) and NYHA Class I, IIExperimental Treatment1 Intervention
Group II: Healthy subjectsExperimental Treatment1 Intervention
Group III: Asymptomatic subjects with a history of left ventricular hypertrophy (LVH) and NYHA Class IExperimental Treatment1 Intervention
Group IV: Asymptomatic subjects with a history of heart failure (HF) and NYHA Class IExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Software
2009
N/A
~100

Find a Location

Who is running the clinical trial?

ProlaioLead Sponsor
1 Previous Clinical Trials
400 Total Patients Enrolled
Michael Koren, MDPrincipal InvestigatorJacksonville Center For Clinical Research
2 Previous Clinical Trials
170 Total Patients Enrolled
~27 spots leftby Nov 2025
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