At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR (diagnostic test), Echocardiogram (diagnostic test), Cardiac MRI (diagnostic test)
- How long the study runs
- Study runs about 56 months (dates as stated)
- About the drug or intervention
- 68Ga-FAPI or 18F-AlF-FAPI cardiac PET-MR — diagnostic test: 200MBq of the above named radiotracer will be administered for PET-MR · Echocardiogram — diagnostic test: Echocardiogram at baseline and 1 year follow-up · Cardiac MRI — diagnostic test: Cardiac MRI at 1 year
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 30 Years to 90 Years
- Who
- All
- Number of participants
- 290
- Started
- 2023-05-01
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for heart failure with preserved ejection fraction
- • Clinical study - 290 participants
- • Heart scarring, also known as fibrosis, plays a major role in a lot of heart muscle abnormalities
Who can take part?
- • Ages 30 Years to 90 Years
- • Diagnosed with heart failure with preserved ejection fraction
Where?
- • Edinburgh - University of Edinburgh
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Heart scarring, also known as fibrosis, plays a major role in a lot of heart muscle abnormalities. These abnormalities of the heart muscle can lead to major issues such as symptoms of heart failure, dangerous heart rhythm disturbances and even death. However, a lot of these conditions are still not fully understood and treatment options are limited. We here aim to use a new radioactive dye called 68Ga-FAPI to identify patterns and the activity of heart muscle scarring. This radioactive dye is being used in humans particularly in identifying and monitoring cancers and has shown promise in identifying scarring in the heart as well. This will help us not only understand the underlying disease process and risk stratify these patients but also potentially help us develop new targeted therapies that can affect heart muscle scarring. Participants will undergo a baseline MRI scan using this new dye and a plain MRI scan will repeated 12-18 months after to see if there are any changes in the process.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 30 Years - 90 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓HFpEF cohort
- ✓Male or female between 30 to 90 years old
- ✓Provision of agreement to take part prior to any study specific procedures
- ✓Hypertrophic cardiomyopathy cohort
- ✓Established diagnosis of hypertrophic cardiomyopathy: left ventricular wall thickness \>15mm by any imaging modality...
Who cannot take part
- ✗Inability or unwilling to give agreement to take part.
- ✗History of claustrophobia or inability to tolerate supine position for the PET/MR or PET/CT scans.
- ✗Impaired kidney function with eGFR of \<30 mL/min/1.73 m2.
- ✗Women who are pregnant or breastfeeding.
- ✗Iodine or gadolinium contrast allergy
See the full criteria
Where Is This Study? (1 UK site)
University of Edinburgh
Edinburgh EH16 5RR, United Kingdom
