Examining fibrosis in heart conditions like aortic stenosis and chemotherapy-induced heart damage
Fibrosis in Chronic and Delayed Myocardial Infarction
This study is testing how fibrosis affects heart conditions like aortic stenosis and heart damage from chemotherapy to better understand its impact on heart health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Edinburgh, Scotland) |
| Trial ID | NCT05756608 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of fibrosis in various heart conditions, including aortic stenosis, chemotherapy-induced cardiotoxicity, and carcinoid syndrome. Using advanced imaging techniques with radiotracers 68Ga-FAPI and 18F-AlF-FAPI combined with PET-MRI or PET-CT, the study aims to identify and analyze fibrosis activity and its correlation with myocardial injury markers. The research will involve multiple patient cohorts, including those with varying severities of aortic stenosis and individuals who have experienced cardiotoxicity from chemotherapy. The goal is to enhance understanding of fibrosis progression and its implications for heart health.
Who should consider this trial
Good fit: Ideal candidates include adults over 50 with aortic stenosis or adults over 35 who have experienced chemotherapy-induced cardiotoxicity.
Not a fit: Patients with significant co-morbidities or those outside the specified age ranges may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of heart conditions associated with fibrosis.
How similar studies have performed: While the approach of using PET imaging to assess fibrosis is established, the specific application to these conditions is novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Cohort 1(Aortic stenosis): * Male or female above the age of 50 years old * Provision of informed consent prior to any study specific procedures * 25 patients with symptomatic severe aortic stenosis (peak velocity \>4.0 m/s) * 25 patients with moderate aortic stenosis (peak velocity 3.0-4.0 m/s) * 10 patients with mild aortic stenosis (peak velocity 2.6-2.9 m/s) * 10 patients with aortic sclerosis (tri-leaflet thickened aortic valve with no obstruction of ventricular outflow) * 10 healthy volunteers (no other significant co-morbidities, as assessed by the study PI) Cohort 2 (Chemotherapy-induced cardiotoxicity): * Male or female over the age of 35 years with evidence of cardiotoxicity on cardiac MRI (performed as part of the Cardiac care study), at least 1 year after anthracycline treatment. * 10 patients over the age of 35 years (male or females) without evidence of fibrosis on their 1-year scan after anthracycline treatment. * 10 healthy volunteers (\>35 years of age) with no significant co-morbidities, as assessed by the study PI. * Provision of informed consent prior to any study specific procedures Cohort 3 (Carcinoid syndrome): * 30 patients with carcinoid syndrome (with or without cardiac involvement), over the age of 35 years, diagnosed as per consensus guidelines * Provision of informed consent prior to any study specific procedures Exclusion Criteria: * Inability or unwilling to give informed consent. * History of claustrophobia or feeling of inability to tolerate supine position for the MRI scans. * Impaired renal function with eGFR of \<30 mL/min/1.73m2. * Women who are pregnant or breastfeeding. * Contrast allergy * Contraindication to cardiac MRI (e.g. metallic implant or severe claustrophobia) * Recent myocardial infarction, other known causes of cardiomyopathy/cardiac fibrosis.
Where this trial is running
Edinburgh, Scotland
- University of Edinburgh — Edinburgh, Scotland, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Krithika Loganath, MBBS
- Email: kloganat@ed.ac.uk
- Phone: 07774365798
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.