A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction

Recruiting Phase 2 Phase 3 Interventional Study
Heart Failure With Preserved Ejection Fraction Heart Failure, Diastolic Diabetes Mellitus, Type 2 Diabetes Mellitus Type 2 in Obese Obesity Adult Onset
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
63 (estimated)
Sponsor
University of Leicester · Other
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About This Trial
Heart failure with preserved ejection fraction (HFpEF) is a common and serious complication of obesity and type 2 diabetes (T2D). HFpEF occurs when the heart muscle unable to relax efficiently to pump the blood around the body. This leads to fluid build-up, breathlessness and inability to tolerate physical exertion. People who develop HFpEF do less well because treatment options are limited. Pilot…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Established clinical diagnosis of heart failure with preserved ejection fraction HFpEF (EF\>45%) made by a cardiologist or a primary care physician with heart failure expertise, or a heart failure nurse 2. Clinically stable for ≥ 3 months (no admissions to hospital) 3. Obesit…
Contacts

Sarah L Ayton, MBBS

+44 (0)116 258 3038

sa768@leicester.ac.uk

CONTACT

Emer M Brady, PhD

44 (0)116 204 4723

emb24@leicester.ac.uk

CONTACT