Last reviewed · How we verify
NCT04776668: LIMA I
Living With Marfan Syndrome and Your Aorta
trial in Marfan Syndrome in 75 participants. Completed in 22 August 2023.
22 August 2023
Quick facts
| Lead sponsor | Barts & The London NHS Trust |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 75 |
| Start date | 5 October 2021 |
| Primary completion | 22 August 2023 |
| Estimated completion | 22 August 2023 |
| Sites | 1 location across United Kingdom |
Conditions studied
- Marfan Syndrome — all drugs for Marfan Syndrome →
- Marfan Syndrome Cardiovascular Manifestations — all drugs for Marfan Syndrome Cardiovascular Manifestations →
Sponsor
Barts & The London NHS Trust — full company profile →
Who can join
Adults 18 to 120, any sex, with Marfan Syndrome or Marfan Syndrome Cardiovascular Manifestations. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Marfan Syndrome (MFS) is a genetic disease affecting the eyes, skeleton, heart and arteries. Despite MFS affecting multiple organ systems, cardiovascular manifestations are the most serious and life threatening. Approximately 80% of adult MFS patients will have a dilated aortic root by age 40 years with aortic aneurysm and dissection the leading causes of morbidity and mortality. Thus, MFS patients require lifelong cardiac surveillance. Living with a diagnosis of Marfan Syndrome and aorto-vascular manifestations affects patients' mental health, well-being and quality of life in ways that are not well understood. This study will address the current knowledge gaps in this area and will provide the information needed to design interventions for MFS patients with aorto-vascular problems to help improve the patients' mental health, well-being and quality of life. The study will include adult MFS patients who have been diagnosed with aorto-vascular problems. The overall aim of the study is to explore the psychosocial and health-related quality of life (HRQoL) effects of the diagnosis for aorto-vascular manifestations of MFS in 3 large UK cardiac centres. To achieve this, the researchers will ask the potential participants, after obtaining informed consent, to complete a series of accepted/validated questionnaires to measure the study participants' health-related quality of life (SF-36 and EQ5D questionnaire) and psychosocial factors such as depression (CES-D questionnaire), fatigue (Fatigue Severity Scale), stigma (Perceived Stigma Questionnaire), self-esteem (Rosenberg Self-esteem Scale), pain and illness perception (Illness Perception Questionnaire). The researcher will also conduct a one-to-one semi-structured interview with some participants to identify factors important to patients that are not captured in the questionnaires used.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04776668
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other recruiting trials for Marfan Syndrome
Currently open trials in the same condition.
- NCT06546137 — National Network for Cardiovascular Genomics: Advancing Cardiovascular Healthcare for Hereditary Diseases in Brazil's Un · recruiting
- NCT05809323 — Marfan Syndrome Moderate Exercise Trial II · NA · recruiting
- NCT04970459 — Biological Collection for Marfan and Related Syndromes · recruiting
- NCT03440697 — Pathogenetic Basis of Aortopathy and Aortic Valve Disease · active not recruiting
Other Barts & The London NHS Trust trials
Trials by the same sponsor.
- NCT05753085 — Multimodality Optical and Ultrasound Intravascular Imaging for Stent Optimization and Atheroma Assessment · NA · withdrawn
- NCT07047235 — Substrate Remodelling and Targeted Ablation in AF · NA · recruiting
- NCT06871215 — Inflammation and Infective Endocarditis · withdrawn
- NCT07076524 — MuScle WastIng and DysphaGia iN CriticAlly IlL Patients (SIGNAL) · recruiting
- NCT06596486 — A Comparison of CoolStick With Ethyl Chloride for the Assessment of Light Touch · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04776668 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Barts & The London NHS Trust
- Last refreshed: 10 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04776668.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing