Health TrialsbyHealthPanel

The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy

ConditionsInflammatory CardiomyopathyMyocarditis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTongji Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hydroxychloroquine

    Drug

    Hydroxychloroquine 200mg qd

  • Prednisolone

    Drug

    Prednisolone 20mg qd

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: HCQ groupExperimental treatment 2 interventions
Group B: Non-HCQ groupActive comparator 1 intervention

Trial outcomes

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.

Time frame
3 years

Secondary outcomes

1

The increase and dynamic changes of LVEF (%)

Measurement of left ventricular ejection fraction (LVEF) by cardiac echocardiography during follow-up.

Time frame
3 years
2

The increase and dynamic changes of LVIDd (mm)

Measurement of left ventricular internal diastolic diameter (LVIDd) by cardiac echocardiography during follow-up.

Time frame
3 years
3

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

Time frame
3 years
4

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

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tongji Hospital

Lead sponsor

Wuhan Central Hospital

Collaborator

Taihe Hospital

Collaborator

Source ClinicalTrials.gov
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