Investigating the impact of heart fat on heart function in patients with heart failure
The Role of Epicardial Adiposity in Heart Failure With Preserved Ejection Fraction
This study is trying to see how fat around the heart affects heart function in people with heart failure, including those who are obese and those who are not.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Leicester, Leicestershire) |
| Trial ID | NCT06768437 on ClinicalTrials.gov |
What this trial studies
This observational study aims to recruit 130 patients diagnosed with heart failure with preserved ejection fraction (HFpEF), both obese and non-obese, to explore the relationship between epicardial adipose tissue (fat around the heart) and heart function. Participants will undergo CT and MRI scans, along with blood tests, to assess how excess fat may contribute to cardiac dysfunction in HFpEF. The study seeks to provide insights into the mechanisms by which adiposity affects heart health, potentially leading to new treatment strategies for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with HFpEF, regardless of their obesity status.
Not a fit: Patients with severe primary valvular heart disease or those with a left ventricular ejection fraction below 45% may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatments aimed at reducing fat levels around the heart, improving outcomes for patients with HFpEF.
How similar studies have performed: While there have been studies on obesity and heart failure, this specific approach focusing on epicardial adipose tissue in a diverse cohort is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Aged ≥18 years old * Diagnosed with HFpEF by an experienced cardiologist or signs and symptoms of heart failure with a HFA-PEFF score ≥5 * Able to understand written English Exclusion Criteria: * LV ejection fraction \<45% * Recovered ejection fraction (previous ejection fraction \<40%) unless reduced ejection fraction was in context of tachycardia induced cardiomyopathy (eg atrial fibrillation/atrial flutter) * Severe primary valvular heart disease * HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy/pericardial disease or congenital heart disease * Known heritable, idiopathic or drug-induced pulmonary arterial hypertension * Absolute contraindications to cardiac CT or MRI including estimated glomerular filtration rate (eGFR) ≤30ml/min/1.73m2. Patients with MRI-compatible devices are be excluded. * Women who are pregnant
Where this trial is running
Leicester, Leicestershire
- Glenfield Hospital, University Hospitals of Leicester — Leicester, Leicestershire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Gaurav S Gulsin, MBChB(Hons)
- Email: gg149@le.ac.uk
- Phone: +44 (0)116 258 3038
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.