Observing heart changes in patients with valvular heart disease
Pathological Changes in the Cardiovascular System in Valvular Heart Disease: Validation of Non-invasive Markers
This study is looking at how valvular heart disease affects the heart and other organs over time in patients to see if they can find early signs that predict outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06060171 on ClinicalTrials.gov |
What this trial studies
This observational cohort study recruits patients with valvular heart disease to investigate the natural history of the condition and its effects on the heart and other organs. Participants will undergo specialized tests, including cardiac imaging and blood tests, to assess myocardial remodeling, scar formation, and vascular changes. The study aims to identify potential early biomarkers for prognosis and understand the long-term outcomes of valvular heart disease. Data will be linked to hospital records to evaluate patient outcomes over time.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with mild to severe valvular heart disease or those scheduled for surgical or transcatheter intervention.
Not a fit: Patients with conditions such as dilated or hypertrophic cardiomyopathy or those with severe coronary disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into early biomarkers for prognosis in valvular heart disease, potentially improving patient management and outcomes.
How similar studies have performed: Other studies have shown success in investigating cardiovascular conditions, but this specific approach focusing on valvular heart disease and its extracardiac effects is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Able to provide written informed consent * Mild, moderate or severe valvular heart disease (Natural history cohort), or severe valvular heart disease planned for surgical/transcatheter intervention (Intervention/Heart-Brain axis cohort). Exclusion Criteria: * Participants unwilling to consent. * Needle phobic patients that would preclude blood taking * Diagnosis of dilated or hypertrophic cardiomyopathy * Pregnancy/breast feeding * Inability to complete the protocol, other conditions that would prevent participation in the study. * In severe VHD, no more than moderate valve disease other than primary lesion (AS / MR / AR) Exclusion for the Heart-Brain-Axis Study: • Participants that have more than moderate epicardial coronary disease (by CT or invasive coronary angiography) will be excluded.
Where this trial is running
London
- Barts Heart Centre — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: George D Thornton, MD
- Email: george.thornton@ucl.ac.uk
- Phone: +4420 3465 5543
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.