CompletedNot Applicable

Early Detection of Cardiac Impairment and Prediction of RV Hypertrophy in Patients With CTD

China136 participantsStarted 2014-07

Plain-language summary

There have been reports suggesting that progressive RV failure and death in connective tissue disease (CTD) are related to right ventricular hypertrophy (RVH) and dilation, irrespective of pulmonary arterial hypertension (PAH). The investigators aim to identify cardiac markers that occur before RVH and to investigate predictors of RVH.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

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 for CTD with RVH * Age between 18-80 years old. * Definite connective tissue diseases diagnosis. * Echocardiography demonstration (later confirmed by CMR) of a hypertrophic RV when maximal end-diastole RV wall thickness \>4 mm due to CTD Inclusion Criteria for CTD without RVH * Age between 18-80 years old. * Definite connective tissue diseases diagnosis. * Echocardiography demonstration (later confirmed by CMR) that maximal end-diastole RV wall thickness ≤4 mm Inclusion Criteria for Control group: * Absence of known systemic diseases * Normal examinations * Age between 18-80 years old. * Providing written informed consent Exclusion Criteria: * Age \<18 years old or \>80 years old * Documented coronary artery disease or prior angiography for coronary artery disease (\>50% stenosis). * Patients with known congenital heart disease or other systemic diseases that might induce RVH. * Patients with standard metallic contraindications to CMR or an estimated glomerular filtration rate \< 30 ml/min/1.73 m2.

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

Composite endpoint of cardiac condition

Timeframe: within 2 days of CMR scan

Composite endpoint of quantitative fibrosis assessment

Timeframe: within 2 days of CMR scan

Trial details

NCT IDNCT04297371

SponsorRenJi Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-11

View on ClinicalTrials.gov More Connective Tissue Diseases trials