The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy

NCT05961202 | Recruiting Phase 2 DMC

• 1 other identifier: TJ-HYPIC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Inflammatory Cardiomyopathy; Myocarditis

Keywords

Inflammatory cardiomyopathy; Myocarditis; Hydroxychloroquine; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Composite cardiovascular outcome

  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 Outcomes (6)

• The increase and dynamic changes of LVEF (%)

  3 years

• The increase and dynamic changes of LVIDd (mm)

  3 years

• The decrease and dynamic changes of hs-cTnI (pg/mL)

  3 years

• The decrease and dynamic changes of NT-proBNP (pg/mL)

  3 years

• The decrease and dynamic changes of hs-CRP (mg/L)

  3 years

Study Arms (2)

HCQ group

EXPERIMENTAL

Hydroxychloroquine 200mg qd and Prednisolone 20mg qd for 12 months

Drug: Hydroxychloroquine; Drug: Prednisolone

Non-HCQ group

ACTIVE COMPARATOR

Prednisolone 20mg qd for 12 months

Drug: Prednisolone

Interventions

Hydroxychloroquine DRUG

Hydroxychloroquine 200mg qd

HCQ group

Prednisolone DRUG

Prednisolone 20mg qd

HCQ group; Non-HCQ group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient aged from 18 to 80 years;
• Left ventricular dysfunction \[left ventricular ejection fraction (LVEF) \<50%\] diagnosed by echocardiography (Simpson's biplane) within 30 days before randomization;
• Chronic heart failure (lasting \>6 months) unresponsive to conventional supportive therapy;
• High-sensitivity cardiac Troponin I (hs-cTnI) \>26.2 pg/mL and N-terminal-pro-B-type natriuretic peptide (NT-proBNP) \>169pg/mL;
• Suffered from confirmed fulminant myocarditis in the past;
• Diagnosed with chronic inflammatory cardiomyopathy confirmed by myocardial biopsy1;
• Absence of cardiotropic viruses at polymerase chain reaction analysis;
• Volunteer for the study and written informed consent;

You may not qualify if:

• Age \<18 or \>80 years;
• Acute myocardial infarction occurred within the past month;
• Subjects who have undergone cardiac surgery or cerebrovascular accidents within 6 months;
• Preparing for heart transplantation;
• With malignant arrhythmias such as long QT syndrome;
• Pregnancy or lactation;
• Have participated in any drug clinical trial within the three months;
• 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).
• Confirmed or possible systemic inflammatory diseases;
• On the brink of death or life expectancy of less than 1 year;
• Drug or alcohol abuse;
• cannot persist in taking medication due to various reasons;
• Inability to provide informed consent.

Sponsors & Collaborators

• Tongji Hospital: lead
• Wuhan Central Hospital: collaborator
• Taihe Hospital: collaborator

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (4)

• He W, Zhou L, Xu K, Li H, Wang JJ, Chen C, Wang D. Immunopathogenesis and immunomodulatory therapy for myocarditis. Sci China Life Sci. 2023 Sep;66(9):2112-2137. doi: 10.1007/s11427-022-2273-3. Epub 2023 Mar 29.

  PMID: 37002488 BACKGROUND

• Ammirati E, Frigerio M, Adler ED, Basso C, Birnie DH, Brambatti M, Friedrich MG, Klingel K, Lehtonen J, Moslehi JJ, Pedrotti P, Rimoldi OE, Schultheiss HP, Tschope C, Cooper LT Jr, Camici PG. Management of Acute Myocarditis and Chronic Inflammatory Cardiomyopathy: An Expert Consensus Document. Circ Heart Fail. 2020 Nov;13(11):e007405. doi: 10.1161/CIRCHEARTFAILURE.120.007405. Epub 2020 Nov 12.

  PMID: 33176455 BACKGROUND

• Hang W, Chen C, Seubert JM, Wang DW. Fulminant myocarditis: a comprehensive review from etiology to treatments and outcomes. Signal Transduct Target Ther. 2020 Dec 11;5(1):287. doi: 10.1038/s41392-020-00360-y.

  PMID: 33303763 BACKGROUND

• He W, Cui G, Chen J, Chen M, Li R, Wang L, Yu T, Li G, Jiang J, Wang DW. The efficacy and safety of hydroxychloroquine in patients with chronic inflammatory cardiomyopathy: a multicenter randomized study (HYPIC trial). BMC Med. 2025 Aug 8;23(1):467. doi: 10.1186/s12916-025-04301-w.

  PMID: 40781621 DERIVED

MeSH Terms

Conditions

Myocarditis

Interventions

Hydroxychloroquine; Prednisolone

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Dao Wen Wang, MD, PhD

CONTACT

+86-027-6937-8422; dwwang@tjh.tjmu.edu.cn

Wu He

CONTACT

+8613972334305; hewu0912@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: November 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

CN (1)