Exploring the impact of heart surgery on Marfan Syndrome patients
Living With Marfan Syndrome II: the Psychosocial and Health-related Quality of Life Effects of Surgical Interventions for Aorto-vascular Manifestations (LIMA II Study)
This study looks at how heart surgery affects the mental health and quality of life of adults with Marfan Syndrome before and after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Barts & The London NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04776681 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on adult patients with Marfan Syndrome (MFS) who are undergoing aorto-vascular surgery. It aims to investigate the psychosocial effects and health-related quality of life (HRQoL) of these patients before and after their surgical interventions. By utilizing validated questionnaires, the study will gather data from participants at multiple time points to better understand the mental health and well-being challenges faced by MFS patients during recovery. The research is being conducted across three major cardiac centers in the UK.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a validated diagnosis of Marfan Syndrome who are scheduled for aorto-vascular surgery.
Not a fit: Patients under 18 years old or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mental health support and quality of life interventions for Marfan Syndrome patients post-surgery.
How similar studies have performed: While there is limited evidence on the psychosocial aspects of recovery in MFS patients, similar studies in other conditions have shown the importance of addressing mental health in surgical recovery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. \>/= 18 years old at the time of surgery; 2. have validated diagnosis of MFS (using revised Ghent criteria); 3. having aorto-vascular surgery Exclusion Criteria: 1. \<18years old at the time of surgery 2. Unable or unwilling to give written informed consent. 3. Inability to understand written and/or verbal English
Where this trial is running
London
- St Bartholomews Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Rosalie Magboo, RN BSc MA, MSc
- Email: rosalie.renamagboo@nhs.net
- Phone: 02037658320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.