Inflammatory CardiomyopathyPhase 2/3HYPICNCT05961202
The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy
A Phase 2/3 study testing Hydroxychloroquine and Prednisolone in people with Inflammatory Cardiomyopathy and Myocarditis, run by Tongji Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammatory Cardiomyopathy, Myocarditis
- What is being tested?
- Hydroxychloroquine and Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Nov 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Dao Wen Wang, MD, PhD, 86-27-6937-8422, dwwang@tjh.tjmu.edu.cn
Wu He, MD, +8613972334305, hewu0912@163.com
About this study
Official title: 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
Read the 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).
- Conditions
- Inflammatory Cardiomyopathy, Myocarditis
- Being tested
- Hydroxychloroquine, Prednisolone
- Keywords
- Inflammatory cardiomyopathy, Myocarditis, Hydroxychloroquine, Randomized controlled trial
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine 200mg qd
PrednisoloneDrug
Prednisolone 20mg qd
| Study group | Role | What they receive |
|---|---|---|
| HCQ group | Experimental | Hydroxychloroquine 200mg qd and Prednisolone 20mg qd for 12 months Receives: Drug: Hydroxychloroquine; Drug: Prednisolone |
| Non-HCQ group | Active comparator | Prednisolone 20mg qd for 12 months Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (6)
The increase and dynamic changes of LVEF (%)
Measurement of left ventricular ejection fraction (LVEF) by cardiac echocardiography during follow-up.
Measured: 3 years
The increase and dynamic changes of LVIDd (mm)
Measurement of left ventricular internal diastolic diameter (LVIDd) by cardiac echocardiography during follow-up.
Measured: 3 years
The decrease and dynamic changes of hs-cTnI (pg/mL)
Measured: 3 years
The decrease and dynamic changes of NT-proBNP (pg/mL)
Measured: 3 years
The decrease and dynamic changes of hs-CRP (mg/L)
Measured: 3 years
The decrease and dynamic changes of ESR (mm/H)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Nov 2021
- Primary completion1 Sep 2024
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Inflammatory CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Central Hospital, Taihe Hospital
- Responsible party
- Principal investigator, Dao Wen Wang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961202
- Sponsor's protocol ID
- TJ-HYPIC
- Acronym
- HYPIC
- Status last verified
- Oct 2024
- First submitted
- 18 Jul 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37002488Ammirati 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.
PubMed 33176455Hang 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.
PubMed 33303763He 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.
PubMed 40781621
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Mechanism of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy After Myocarditis
- ClinicalTrials.gov ID
- NCT05961202
- Acronym / sponsor ID
- HYPIC / TJ-HYPIC
- Conditions
- Inflammatory Cardiomyopathy, Myocarditis
- Keywords
- Inflammatory cardiomyopathy, Myocarditis, Hydroxychloroquine, Randomized controlled trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Wuhan Central Hospital, Taihe Hospital
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCQ group | Experimental | Drug: Hydroxychloroquine, Drug: PrednisoloneHydroxychloroquine 200mg qd and Prednisolone 20mg qd for 12 months |
| Non-HCQ group | Active comparator | Drug: PrednisolonePrednisolone 20mg qd for 12 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineHydroxychloroquine 200mg qd | Drug | HCQ group |
| PrednisolonePrednisolone 20mg qd | Drug | HCQ group, Non-HCQ group |
Primary outcome
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.
6 secondary outcomes
The increase and dynamic changes of LVEF (%)
Time frame: 3 years
The increase and dynamic changes of LVIDd (mm)
Time frame: 3 years
The decrease and dynamic changes of hs-cTnI (pg/mL)
Time frame: 3 years
The decrease and dynamic changes of NT-proBNP (pg/mL)
Time frame: 3 years
The decrease and dynamic changes of hs-CRP (mg/L)
Time frame: 3 years
The decrease and dynamic changes of ESR (mm/H)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Background: PubMed 37002488He 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.
- Background: PubMed 33176455Ammirati 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.
- Background: PubMed 33303763Hang 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.
- Derived from this study: PubMed 40781621He 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hydroxychloroquine and Prednisolone in people with Inflammatory Cardiomyopathy and Myocarditis, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dao Wen Wang, MD, PhD (+86-027-6937-8422, dwwang@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite cardiovascular outcome (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05961202, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.