UnknownPhase 2/3

Bisoprolol in DMD Early Cardiomyopathy

China42 participantsStarted 2019-01-16

Plain-language summary

This study aimed to use cardiac magnetic resonance imaging (CMR) to evaluate the efficacy and safety of bisoprolol therapy for boys with Duchenne muscular dystrophy(DMD) and preserved ejection fraction. On top of angiotensin-converting enzyme inhibitor (ACEI) , half of the participants will receive bisoprolol in combination, while the other half will not receive any beta-blocker.

Who can participate

Age range

7 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Older than(including) 7 years old * A definite diagnosis of DMD with muscle pathology confirming the expression of dystrophin lower than 5% and/or confirmed mutations in the DMD gene using a clinical accepted technique that completely defines the mutation. * Using ACEI or ARB for more than 1 month * Confirmed myocardial damage in one or more left ventricular segments evident by late gadolinium enhancement and preserved left ventricular systolic function(\>45%) by cine cardiac MR in 45 days * Normal renal function * Holter and blood pressure shows no contraindication of using bisoprolol Exclusion Criteria: * Having metal implanted in body * Having claustrophobia * Allergic to gadolinium * Complicated with other cardiovascular diseases * Medical history or Holter show bradyarrhythmia like II/III degree atrioventricular block, sick sinus syndrome etc. * Systolic blood pressure lower than 90mmHg or rest heart rate lower than 75bpm * Having COPD or asthma history * Having other complications: tumor, endocrine diseases * Having beta blockers therapy * Planned operation in the future 12 months * Allergic to bisoprolol

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Calculate the change of left ventricle global longitudinal strain in cardiac MR

Timeframe: baseline and 12 months

Trial details

NCT IDNCT03779646

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-01

Contact for this trial

Guo, Doctor

+86-010-69155068 xiaoxiaoguopumch@163.com

View on ClinicalTrials.gov More Duchenne Muscular Dystrophy trials