The Role of Epicardial Adiposity in Heart Failure With Preserved Ejection Fraction

NCT06768437 | Recruiting

• 1 other identifier: 1003
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators are aiming to recruit 130 patients with heart failure with preserved ejection fraction who are obese and non-obese to undergo CT and MRI scans, as well as some other investigations including blood tests, to help investigate if having more fat around the heart leads to worse heart function in this condition. This may lead to the development of new treatments aimed at lowering fat levels around the heart and in the rest of the body, specifically to treat HFpEF.

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Keywords

Heart failure; Heart failure with preserved ejection fraction; Epicardial adipose tissue; Adiposity

Outcome Measures

Primary Outcomes (3)

• Epicardial adipose tissue volume

  Cardiac CT

  At baseline

• Epicardial Adipose tissue CT attenuation

  Cardiac CT

  At baseline

• Left ventricular mass:volume ratio

  Cardiac MRI

  At baseline

Secondary Outcomes (7)

• Left ventricular global longitudinal strain

  At baseline

• Left ventricular circumferential peak early diastolic strain rate

  At baseline

• Myocardial blood flow

  At baseline

• left ventricular filling pressure

  At baseline

• Six minute walk test

  At baseline

Study Arms (1)

Participants with HFpEF

Obese and non-obese participants with heart failure with preserved ejection fraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males and females, aged ≥18 years old, with a diagnosis of HFpEF with and without obesity.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

Glenfield Hospital, University Hospitals of Leicester

Leicester, Leicestershire, LE3 9QP, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Heart Failure; Obesity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gaurav S Gulsin, MBChB(Hons)

CONTACT

+44 (0)116 258 3038; gg149@le.ac.uk

Sarah L Ayton, MBBS

CONTACT

sa768@le.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 10, 2025
• Study Start: February 12, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2037
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

GB (1)