A Multi-Ethnic, Multi-centre raNdomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction (AMEND-preserved)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test, Drug, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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 data in patients with obesity and diabetes and a small number of patients with HFpEF have shown improvements in exercise capacity and reversal of changes in the heart and blood vessels. This study will assess if this is achievable in a multi-ethnic cohort of patients with established HFpEF. A total of 63 adults will be invited and allocate by chance into two groups: 1) 12-weeks of a low calorie diet or 2) Standard care and health advice on how to lose weight followed by the option to have the low calorie diet after 12-weeks. The study will determine if weight loss over 12 weeks can improve heart function, symptoms and ability to exercise. Additionally, participants' views on changing their diet and how this has impacted their symptoms will be sought during the study in an optional interview. This will help guide treatments planning in the future to get maximum benefits, and to individualize support to patients from different cultural backgrounds.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Clinically stable for ≥ 3 months (no admissions to hospital)

• Obesity (BMI ≥30kg/m2 if white European or ≥27kg/m2 if Asian, Middle Eastern or Black ethnicity)

• Age ≥18

Locations
Other Locations
United Kingdom
University of Leicester, Glenfield Hospital, Groby Road
RECRUITING
Leicester
University of Manchester, Wythenshawe Hospital, Southmoor Road
RECRUITING
Manchester
University of Oxford, John Radcliffe Hospital, Headley Way
RECRUITING
Oxford
Contact Information
Primary
Sarah L Ayton, MBBS
sa768@leicester.ac.uk
+44 (0)116 258 3038
Backup
Emer M Brady, PhD
emb24@leicester.ac.uk
44 (0)116 204 4723
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 63
Treatments
Experimental: Low calorie meal replacement plan (MRP) arm
The MRP comprises of 3-4 meals a day (850kcal/day) supplied by Counterweight. Participants will be supported by professional research dieticians, and a study clinician. Participant health and medications will be monitored throughout the study.~Offered to the comparator arm after 12 weeks as a control participant.
Active_comparator: Wait list control arm: Guideline driven care with attention control arm followed by optional MRP
Dietary advice to participants will be given in line with NICE guidelines for cardiovascular risk modification. Heart failure specific advice on exercise will be given in line with guidelines. After 12 weeks as a control participant, these individuals will then have the option to receive the meal replacement plan and repeat assessments after a further 12 weeks.
Sponsors
Collaborators: University of Leeds, University of Manchester, University of Oxford
Leads: University of Leicester

This content was sourced from clinicaltrials.gov