BridgeMD
New treatment option for Inflammatory Cardiomyopathy
Official title The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy
ClinicalTrials.gov ID: NCT05961202
What this study is testing
What is Hydroxychloroquine?
Hydroxychloroquine is an investigational medicine, being studied as a potential treatment for inflammatory cardiomyopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
- 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;
You likely can't join if
- Age \ 80 years;
- Acute myocardial infarction occurred within the past month;
- people 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;
See the full eligibility criteria
- 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;
- Age \ 80 years;
- Acute myocardial infarction occurred within the past month;
- people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.