Impact Of CardiolRxTM On Recurrent Pericarditis

Overview

About this study

The purpose of this study is to evaluate the effect of treatment with CardiolRxTM on recurrent pericarditis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female 18 years of age or older.
  • Diagnosis of at least two episodes of recurrent pericarditis*.
  • At least 1 day with pericarditis pain ≥4 on the 11-point Numerical Rating Scale (NRS) within prior 7 days.
  • One of:
    • C-Reactive Protein** (CRP) level ≥ 1.0 mg/dL within prior 7 days; OR
    • Evidence of pericardial inflammation assessed by delayed pericardial hyperenhancement on cardiac magnetic resonance imaging (CMR).
  • Has received non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine and/or corticosteroids (in any combination) in stable doses for at least 3 days prior to enrolment.
  • Male patients with partners of childbearing potential who have had a vasectomy or are willing to use double barrier contraception methods during the conduct of the study and for 2 months after the last dose of study drug.
  • Women of childbearing potential willing to use an acceptable method of contraception starting with study drug administration and for a minimum of 2 months after study completion. Otherwise, women must be postmenopausal (at least 1 y absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone [FSH] ≥ 40 mIU/mL [or ≥ 40 IU/L] if less than 2 y postmenopausal) or be surgically sterile.
  • Diagnosis of pericarditis according to the 2015 European Society of Cardiology (ESC) Guidelines for the Diagnosis and Management of Pericardial Diseases (Adler et al. 2015):
  • At least two of:
    • Pericarditic chest pain;
    • Pericardial rub;
    • New widespread ST-segment elevation or PR-segment depression according to electrocardiogram (ECG) findings;
    • Pericardial effusion (new or worsening);
    • Conversion: 1 mg/dL CRP = 10 mg/L hs-CRP.

Exclusion Criteria:

  • Diagnosis of pericarditis that is secondary to specific prohibited etiologies, including tuberculosis (TB); neoplastic, purulent, or radiation etiologies; post-thoracic blunt trauma (e.g., motor vehicle accident); myocarditis.
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min.
  • Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal (ULN) or ALT or AST > 3 x ULN plus bilirubin > 2 x ULN.
  • Sepsis, defined as documented bacteremia at the time of presentation or other documented active infection.
  • History of QT interval prolongation.
  • QTc interval > 500 msec.
  • Current participation in any research study involving investigational drugs or device.
  • Inability or unwillingness to give informed consent.
  • Ongoing drug or alcohol abuse.
  • On any cannabinoid during the past month.
  • Women who are pregnant or breastfeeding.
  • Current diagnosis of cancer, with the exception of non-melanoma skin cancer.
  • Any factor, which would make it unlikely that the patient can comply with the study procedures.
  • Body weight > 170 kg.
  • Showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS), administered at screening.
  • On immunosuppressive therapy with any of the following:
    • Rilonacept;
    • Anakinra;
    • Canakinumab.
  • Methotrexate.
  • Azathioprine.
  • Cyclosporine.
  • Intravenous immune globulin (IVIG).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/29/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sushil Luis, M.B.B.S., Ph.D.

Closed for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

Publications are currently not available