The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy (HYPIC)

October 6, 2024 updated by: Dao Wen Wang, Tongji Hospital

The Efficacy and Mechanism of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy After Myocarditis

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 before randomization;
  3. Chronic heart failure (lasting >6 months) unresponsive to conventional supportive therapy;
  4. High-sensitivity cardiac Troponin I (hs-cTnI) >26.2 pg/mL and N-terminal-pro-B-type natriuretic 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 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 6 months;
  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 (including hypersensitivity to prednisone or hydroxychloroquine, mainly untreated systemic infection, 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 < 11 g/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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCQ group
Hydroxychloroquine 200mg qd and Prednisolone 20mg qd for 12 months
Drug: Hydroxychloroquine
Hydroxychloroquine 200mg qd
Drug: Prednisolone
Prednisolone 20mg qd
Active Comparator: Non-HCQ group
Prednisolone 20mg qd for 12 months
Drug: Prednisolone
Prednisolone 20mg qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite cardiovascular outcome
Time Frame: 3 years
The composite cardiovascular outcome of time to cardiovascular death or heart transplant, hospitalization for heart failure or recurrence of myocarditis, permanent pacemaker use, or ICD implantation.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The increase and dynamic changes of LVEF (%)
Time Frame: 3 years
Measurement of left ventricular ejection fraction (LVEF) by cardiac echocardiography during follow-up.
3 years
The decrease and dynamic changes of hs-cTnI (pg/mL)
Time Frame: 3 years
3 years
The decrease and dynamic changes of NT-proBNP (pg/mL)
Time Frame: 3 years
3 years
The increase and dynamic changes of LVIDd (mm)
Time Frame: 3 years
Measurement of left ventricular internal diastolic diameter (LVIDd) by cardiac echocardiography during follow-up.
3 years
The decrease and dynamic changes of hs-CRP (mg/L)
Time Frame: 3 years
3 years
The decrease and dynamic changes of ESR (mm/H)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Collaborators

Taihe Hospital
Wuhan Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

September 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 6, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-HYPIC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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