Comparing Immune System Suppression to Medication for Unexplained Heart Function and Irregular Heartbeat

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Roderick Tung
Study ID
NCT06635863
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Arrhythmogenic Inflammatory Cardiomyopathy
  • Non-ischemic Cardiomyopathy
  • Ventricular Arrythmia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prednisone 40mg — DRUG
    Prednisone 40mg x 8weeks

Study Details

Ventricular tachycardia (VT, a potentially fatal condition where the ventricle of the heart beats rapidly) superimposed on non-ischemic cardiomyopathy (NICM, a disease of heart with broad etiologies except coronary artery disease). This disease has been associated with inflammation in the heart. The purpose of this study is to assess the benefit of immunosuppressive therapy to suppress the VT, improve heart function, avoid invasive intervention and hospitalization. Positron Emission Tomography (PET) imaging shows inflammation in the heart. After enrollment, baseline tests (including physical exams, blood tests, genetic test, electrocardiography, echocardiography) will be done. Next, will be an 8-week medication regimen which contains either immunosuppressive drugs or standard GDMT without immunosuppressant medication. Some of the examinations will be repeated during the study to evaluate the treatment response and monitor any adverse events.

Key Dates

Start date
Nov 1, 2024
Status verified
Dec 2024
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immunosuppression
    Prednisone 40mg x 8weeks + GDMT
  • No Intervention: Standard of Care
    GDMT alone

Primary Outcome Measure

Burden of ventricular arrhythmias [ Time Frame: 12 months (8 weeks and 6 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Banner - University Medical Center, Phoenix campusPhoenixArizona85006-

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Banner - University Medical Center, Phoenix campus· Phoenix, AZ

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