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

NCT06635863 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: STUDY00003729
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventricular Arrythmia; Non-ischemic Cardiomyopathy; Arrhythmogenic Inflammatory Cardiomyopathy

Keywords

immunosuppressive therapy; immunomodulatory; inflammation by FDG; guideline-direct medical therapy

Outcome Measures

Primary Outcomes (4)

• Burden of ventricular arrhythmias

  Documented sustained monomorphic ventricular tachycardia \>30 seconds or any appropriate defibrillator therapy (shock or antitachycardia pacing).

  12 months (8 weeks and 6 months)

• Change in left ventricular ejection fraction (LVEF)

  Left ventricular ejection fraction measured with Simpson method with echocardiography.

  12 months (8 weeks and 6 months)

• Change in QRS duration

  QRS duration (milliseconds) measured with a 12-lead ECG.

  12 months (8 weeks and 6 months)

• Change in FDG (18F-fluorodeoxyglucose) uptake

  Change in FDG uptake compared to initial uptake assessed with 18F-fluorodeoxyglucose PET (FDG-PET). Myocardial FDG uptake will be reported as non, focal or diffuse and/or isolated with focal pattern.

  12 months

Secondary Outcomes (4)

• Cardiovascular hospitalization

  6 months and 12 months.

• Need for catheter ablation

  6 months and 12 months.

• NYHA functional class

  6 months and 12 months

• Survival

  6 months and 12 months

Other Outcomes (2)

• Medication adverse events

  6 months and 12 months

• System related adverse events

  6 months and 12 months.

Study Arms (2)

Immunosuppression

EXPERIMENTAL

Prednisone 40mg x 8weeks + GDMT

Drug: Prednisone 40mg

Standard of Care

NO INTERVENTION

GDMT alone

Interventions

Prednisone 40mg DRUG

Prednisone 40mg x 8weeks

Immunosuppression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age, all races, all gender
• LV systolic function \< 50%
• Optimized GDMT Per physicians' discretion (SOC treatment)
• No evidence of ischemic cardiomyopathy
• No evidence of obstructive coronary disease
• Viral panel negative
• NYHA class II, III and ambulatory class IV heart failure
• History of VA (documentation of Sustained VT last more than 30 seconds)
• Heart inflammation confirmed by PET scan
• Steroid use within 12 months prior to of date of consent

You may not qualify if:

• Life expectancy less than 24 months
• Pregnancy
• Contra indications or intolerance of prednisone or any excipients in the formulation
• Hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome, active infection, glaucoma or any other pathology where corticosteroids are not recommended.
• Any patient with HIV, low white blood cells, and chronic infection (active fungal, TB, Valley fever)

Sponsors & Collaborators

• Roderick Tung: lead

Study Sites (1)

Banner - University Medical Center, Phoenix campus

Phoenix, Arizona, 85006, United States

Location

Related Publications (18)

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• Wicks EC, Menezes LJ, Barnes A, Mohiddin SA, Sekhri N, Porter JC, Booth HL, Garrett E, Patel RS, Pavlou M, Groves AM, Elliott PM. Diagnostic accuracy and prognostic value of simultaneous hybrid 18F-fluorodeoxyglucose positron emission tomography/magnetic resonance imaging in cardiac sarcoidosis. Eur Heart J Cardiovasc Imaging. 2018 Jul 1;19(7):757-767. doi: 10.1093/ehjci/jex340.

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  PMID: 18456644 BACKGROUND

• Peretto G, Sala S, Rizzo S, De Luca G, Campochiaro C, Sartorelli S, Benedetti G, Palmisano A, Esposito A, Tresoldi M, Thiene G, Basso C, Della Bella P. Arrhythmias in myocarditis: State of the art. Heart Rhythm. 2019 May;16(5):793-801. doi: 10.1016/j.hrthm.2018.11.024. Epub 2018 Nov 24.

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MeSH Terms

Interventions

Prednisone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine; Chief, Division of Cardiology

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion of study and stored for future unspecified research. Only de-identified data will be made available.
• Access Criteria: A request for access to the de-identified data will be made and access will only be granted to those with permission from the PI.

Locations

US (1)