Minneapolis Heart Institute Foundation

REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients

Status: Recruiting

Location: Alaska Heart & Vascular Institute, Barnes-Jewish Hospital/Washington University, Brigham and Women's Hospital, Carnegie Mellon University, Cincinnati Children's Hospital Medical Center, Cleveland Clinic, Houston Methodist Hospital, Johns Hopkins University, Legacy Hospital and Health Center DBA Legacy Research Institute, Mayo Clinic in Rochester, Midwest Cardiovascular Research Foundation, Minneapolis Heart Institute Foundation, NYU Langone Health, Northwell Health - Lenox Hill Hospital, Pima Heart and Vascular, Scripps Health, Seattle Children's Hospital, TKL Research Inc., University of California - San Diego, University of Nebraska Medical Center, University of Vermont Medical Center, Virginia Commonwealth University

Conditions: Alaska Heart & Vascular Institute, Barnes-Jewish Hospital/Washington University, Brigham and Women's Hospital, Carnegie Mellon University, Cincinnati Children's Hospital Medical Center, Cleveland Clinic, Houston Methodist Hospital, Johns Hopkins University, Legacy Hospital and Health Center DBA Legacy Research Institute, Mayo Clinic in Rochester, Midwest Cardiovascular Research Foundation, Minneapolis Heart Institute Foundation, NYU Langone Health, Northwell Health - Lenox Hill Hospital, Pima Heart and Vascular, Scripps Health, Seattle Children's Hospital, TKL Research Inc., University of California - San Diego, University of Nebraska Medical Center, University of Vermont Medical Center, Virginia Commonwealth University

City/State:

Anchorage, Alaska

Tucson, Arizona

La Jolla, California

San Diego

Davenport, Iowa

Baltimore, Maryland

Boston, Massachusetts

Minneapolis, Minnesota

Rochester, Minnesota

Saint Louis, Missouri

Omaha, Nebraska

Fair Lawn, New Jersey

New York, New York

Cincinnati, Ohio

Cleveland, Ohio

Portland, Oregon

Pittsburgh, Pennsylvania

Houston, Texas

Burlington, Vermont

Richmond, Virginia

Seattle, Washington

Contact Information:

JoAnn Clair, PhD
781 431 9100
[email protected]

Brief Summary:
The registry will focus on furthering the understanding of the natural history of recurrent pericarditis (RP), as well as document RP-related clinical, health-related quality of life (HRQoL), and economic burden and will assist the medical community to refine or develop data-driven recommendations for clinical management of RP patients to optimize clinical outcomes. It also aims to generate data in support of the impact of rilonacept on clinical outcomes in a real-world population.
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Impact of CardiolRxTM on Recurrent Pericarditis (MAvERIC-Pilot)

Status: Recruiting

Location: Cleveland Clinic, Massachusetts General Hospital, Mayo Clinic in Rochester, MedStar Heart and Vascular Institute, Minneapolis Heart Institute Foundation, Pima Heart and Vascular, University of Vermont Medical Center, Virginia Commonwealth University

Conditions: Cleveland Clinic, Massachusetts General Hospital, Mayo Clinic in Rochester, MedStar Heart and Vascular Institute, Minneapolis Heart Institute Foundation, Pima Heart and Vascular, University of Vermont Medical Center, Virginia Commonwealth University

City/State:

Tucson, Arizona

Washington D.C.

Minneapolis, Minnesota

Rochester, Minnesota

Cleveland, Ohio

Burlington, Vermont

Richmond, Virginia

Boston, Massachusetts

Contact Information:

Andrea B Parker, PhD
+1 289 910 0862
[email protected]

Andrew Hamer, MD
[email protected]

Brief Summary:
Patients with recurrent pericarditis who are refractory or intolerant to current therapeutic management options or who require long-term administration of corticosteroids to control their disease are particularly challenging to manage. The pathogenesis of pericarditis involves the activation of the inflammasome. CardiolRxTM is known to have anti-inflammatory properties, including modulation of inflammasome signaling. This pilot study is to assess the tolerance and safety of CardiolRxTM during the resolution of pericarditis symptoms, assess improvement in objective measures of disease, and during the extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids while taking CardiolRxTM.
Detailed Description:

Multi-center, open label Pilot Study. Patients who present with recurrent pericarditis will be screened and informed consent obtained.

Baseline assessments include the following: Clinical assessment, including vital signs, highest NRS pain score within the past 7 days of Day 1, 12-lead ECG; C-SSRS as well as hematology and blood chemistry and a pregnancy test for women with child-bearing potential.

Concomitant medications are recorded and any (S)AEs after informed consent has been obtained.

Study treatment will be initiated in the evening of Day 1, after all baseline assessments are completed.

Oral administration is as follows:

  • Initial starting dose (Day 1 p.m. dose to Day 3 a.m. dose):5 mg/kg of body weight CardiolRxTM
  • Day 3 p.m. dose to Day 10 a.m. dose: 7.5 mg/kg of body weight CardiolRxTM b.i.d.
  • Day 10 p.m. dose to end of treatment period: 10.0 mg/kg of body weight CardiolRxTM b.i.d.

If the next higher dose after each study drug increase is not tolerated, the dose will be reduced to the previous tolerated dose.

Unless contraindicated in the opinion of the investigator, after 8 weeks of treatment, patients will enter an 18-week extension period (EP), in which they continue study treatment while their concomitant medications will be weaned.

Follow-up Procedures Every visit (before the next dose increase) the patient will be re-evaluated. This includes ECG monitoring at approximately 5 hours post-morning dose (Tmax) to surveil for deleterious effects on ECG intervals (particularly the QTc interval) and rhythm.

Drug titration will be dependent on investigator or designate interrogation of the ECGs and the absence of new, clinically significant abnormalities on those ECGs.

Vital signs, concurrent medication and (S)AEs will be recorded at all visits. Blood chemistry including liver function tests, hematology as well as INR assessments will be carried out at selected visits.

Final efficacy assessments will take place after 26 weeks of study treatment and include a clinical assessment, vital signs, pain score NRS, a 12-lead ECG, the C-SSRS, as well as laboratory assessments.

For patients who do not enter the EP, Final assessments will be done after 8 weeks.

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Impact of CardiolRx on Myocardial Recovery in Patients with Acute Myocarditis (ARCHER)

Status: Recruiting

Location: Cleveland Clinic, Massachusetts General Hospital, MedStar Heart and Vascular Institute, Minneapolis Heart Institute Foundation, University of Pittsburgh Medical Center, Virginia Commonwealth University

Conditions: Cleveland Clinic, Massachusetts General Hospital, MedStar Heart and Vascular Institute, Minneapolis Heart Institute Foundation, University of Pittsburgh Medical Center, Virginia Commonwealth University

City/State:

Washington, DC

Miami Lakes, Florida

Boston, Massachusetts

Minneapolis, Minnesota

Cleveland, Ohio

Pittsburgh, Pennsylvania

Richmond, Virginia

Contact Information:

Andrea B Parker, MSc, PhD
+1 289.910.0862
[email protected]

Andrew Hamer, MD
+1 289.910.0380
[email protected]

Brief Summary:

Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis will be screened and, if eligible, randomized within 10 days of the diagnostic CMR to CardiolRx or placebo.

The treatment period is 12 weeks; a last follow-up visit is scheduled one week after the last treatment, 13 weeks after randomization. Study assessments include Cardiac Magnetic Resonance imaging (CMR), ECG monitoring, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as physical exams and laboratory tests.

The primary and secondary outcome parameters are measured by CMR. Additional outcomes include clinical endpoints and changes in inflammatory and biomarkers.

Detailed Description:

Rationale:

Myocarditis is an acute inflammatory condition of the myocardium. Presentation of the disease may be fulminant and necessitate cardiac support, or even result in sudden cardiac death; milder cases are usually self-limiting but may progress to dilated cardiomyopathy with eventual end-stage heart failure. Other than treatments for associated heart failure there are no specific indicated treatments for myocarditis. CardiolRxTM, which is known to have anti-inflammatory properties, is being investigated to treat the underlying inflammatory process and thereby favorably modify acute myocarditis. The primary endpoints of the trial are cardiac magnetic resonance measures of left ventricular systolic function (ejection fraction and longitudinal strain) and myocardial edema (extra cellular volume) which have been shown to predict long term prognosis of patients with acute myocarditis.

Multi-center, double-blind, randomized, placebo-controlled, parallel group design. 1:1 randomization; treatment will be stratified within sites.

Patients diagnosed with acute myocarditis by a biopsy or a CMR will be screened within 10 days of the diagnostic CMR. Informed consent will be obtained at this point. For patients who have been diagnosed using an EMB, a CMR needs to be performed as well, which will be included in the informed consent form (ICF).Eligible patients will then be randomized within 10 days from the CMR assessment.

Baseline assessments include the following: Clinical assessment, including vital signs, ECG, 24-hr Holter, chest x-ray; Hematology and blood chemistry, NYHA classification, C SSRS and KCCQ. Frozen plasma will be retained for central analysis of hs-troponin, NT-proBNP and inflammatory markers.

Study treatment needs to be taken with food and will be initiated in the evening of Day 1, after all baseline assessments have been completed and the patient has been randomized.

Oral administration is as follows:

    • Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
    • Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
    • Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
    • Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo

If the next higher dose after each study drug increase is not tolerated, the dose will be reduced to the previous tolerated dose.

Every week (before the next dose increase) the patient will be re-evaluated. This includes ECG monitoring at approximately 5 hours post-morning dose (time of Tmax) to surveil for deleterious effects on ECG intervals (particularly the QTc interval) and rhythm. Drug titration will be dependent on investigator or designate interrogation of the ECGs and the absence of new, clinically significant abnormalities on those ECGs.

Vital signs, concurrent medication and Adverse Events (AEs), including Serious Adverse Events (SAEs) will be recorded, blood chemistry including liver function tests, hematology as well as INR assessments will be carried out.

Final efficacy assessments (including a second CMR) will take place after 12 weeks of study treatment. A final safety assessment will take place after 13 weeks, 1 week after completion of study treatment.

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[email protected]

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