The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy

Last updated: October 6, 2024
Sponsor: Tongji Hospital
Overall Status: Active - Recruiting

Phase

2/3

Condition

Cardiomyopathy

Chest Pain

Dermatomyositis (Connective Tissue Disease)

Treatment

Prednisolone

Hydroxychloroquine

Clinical Study ID

NCT05961202
TJ-HYPIC
  • Ages 18-80
  • All Genders

Study Summary

Evaluating the long-term therapeutic effects and safety of hydroxychloroquine(compared to glucocorticoid therapy alone) in patients with inflammatory cardiomyopathy--a multicenter randomized controlled study

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Male or female patient aged from 18 to 80 years;

  2. Left ventricular dysfunction [left ventricular ejection fraction (LVEF) <50%]diagnosed by echocardiography (Simpson's biplane) within 30 days beforerandomization;

  3. Chronic heart failure (lasting >6 months) unresponsive to conventional supportivetherapy;

  4. High-sensitivity cardiac Troponin I (hs-cTnI) >26.2 pg/mL and N-terminal-pro-B-typenatriuretic peptide (NT-proBNP) >169pg/mL;

  5. Suffered from confirmed fulminant myocarditis in the past;

  6. Diagnosed with chronic inflammatory cardiomyopathy confirmed by myocardial biopsy1;

  7. Absence of cardiotropic viruses at polymerase chain reaction analysis;

  8. Volunteer for the study and written informed consent;

Exclusion

Exclusion criteria:

  1. Age <18 or >80 years;

  2. Acute myocardial infarction occurred within the past month;

  3. Subjects who have undergone cardiac surgery or cerebrovascular accidents within 6months;

  4. Preparing for heart transplantation;

  5. With malignant arrhythmias such as long QT syndrome;

  6. Pregnancy or lactation;

  7. Have participated in any drug clinical trial within the three months;

  8. Presence of contraindications to prednisolone and/or hydroxychloroquine (includinghypersensitivity to prednisone or hydroxychloroquine, mainly untreated systemicinfection, uncontrolled diabetes, poorly controlled endocrine diseases,osteoporosis, gastric or duodenal ulcer, uncontrolled hypertension, leukocytopenia (leukocyte counts < 4×109/L), neutropenia (neutrophils < 1.5×109/L),thrombocytopenia (platelet levels < 130×109/L), anemia (hemoglobin levels < 11g/dL).

  9. Confirmed or possible systemic inflammatory diseases;

  10. On the brink of death or life expectancy of less than 1 year;

  11. Drug or alcohol abuse;

  12. cannot persist in taking medication due to various reasons;

  13. Inability to provide informed consent.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Prednisolone
Phase: 2/3
Study Start date:
November 01, 2021
Estimated Completion Date:
November 01, 2025

Study Description

Inflammatory cardiomyopathy is the chronic stage of myocarditis, which is associated with poor cardiovascular outcome and poor prognosis.Inflammatory cardiomyopathy is also one of the common causes of heart failure. Actually, the treatment and prognosis of inflammatory cardiomyopathy remain challenging clinical issues that often have frustrating consequences. So far, there is no specific treatment for inflammatory cardiomyopathy. Hydroxychloroquine is a drug that can effectively inhibit inflammation and has been used in many inflammatory diseases in the past. Our previous basic research has proved that hydroxychloroquine can effectively treat experimental autoimmune myocarditis.Therefore, multicenter large randomized controlled trials are needed to verify the therapeutic effects of hydroxychloroquine on patients with inflammatory cardiomyopathy.

Patients with inflammatory cardiomyopathy after acute myocarditis confirmed by biopsy received standard drug treatment for heart failure. These patients whose cardiac function could not be improved for a long time were randomly assigned (1:1) to hydroxychloroquine group (hydroxychloroquine and glucocorticoid) and glucocorticoid group (glucocorticoid alone). The clinical benefit will be measured with respect to absolute increase in LVEF and decrease in hs-cTnI and NT-proBNP of immunosuppressive treatment with hydroxychloroquine and prednisolone compared to prednisolone alone at long-term follow-up (1, 3, 6, 9, 12, 18, 24, 36 months).

Connect with a study center

  • Tongji Hospital

    Wuhan, Hubei 430030
    China

    Active - Recruiting

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