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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

December 5, 2023

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2026

Conditions
Heart Failure With Preserved Ejection FractionHeart Failure, DiastolicDiabetes Mellitus, Type 2Diabetes Mellitus Type 2 in ObeseObesity Adult Onset
Interventions
DRUG

Low calorie meal replacement plan

Meal replacement diet containing \~850 kcal/day (40% protein, 50% carbohydrate, 10% fat) supplied by Counterweight® (www.counterweight.org).The meal replacement plan will comprise of 3-4 meal packs/day (to equate to 850 kcal) with sweet and savoury options, and an allowance of 100ml semi-skimmed milk or a non-dairy alternative.

DIAGNOSTIC_TEST

Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy

CMR scanning performed on a 3T MRI scanner. Standardised protocol incorporating cine functional assessment to determine LV mass, systolic function and left atrial volumes; global systolic strain and diastolic strain rates will be assessed by tagging and with tissue tracking analysis from cine images, adenosine rest and stress myocardial perfusion to assess reserve index and qualitative perfusion defects as previously described, aortic distensibility and pulse wave velocity to measure aortic stiffness, delayed contrast enhancement for assessment of LV fibrosis and evidence of previous myocardial infarction. Myocardial and liver triglyceride content will be assessed using the modified Hepafat® sequence or 1H MR spectroscopy at the inter ventricular septum. DIXON technique for the quantification of visceral adiposity and subcutaneous adipose tissue. Cardiac 31P magnetic resonance spectroscopy imaging to assess cardiac muscle energetics according to a standardised operating procedure

DIAGNOSTIC_TEST

Transthoracic echocardiography

Comprehensive transthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of LV size and function

DIAGNOSTIC_TEST

Blood test

Collection of blood samples from each participant to characterise the participant's health status and fibroinflammatory markers.

DIAGNOSTIC_TEST

Electrocardiogram

An ECG will be obtained to assess for baseline rhythm.

DIAGNOSTIC_TEST

Accelerometery

Accelerometer (GeneActiv) measured daily activity levels continuously for 7 consecutive days.

DIAGNOSTIC_TEST

6 minute walk test (6MWT)

Supervised 6MWT will be performed with symptom assessment using dyspnoea scale (Borg's).

DIAGNOSTIC_TEST

Skeletal muscle strength using handgrip strength and quadriceps (Cybex dynamometer)

Skeletal muscle strength will be measured using a cybex dynamometer.

OTHER

Assessment of quality of life and heart failure symptoms

Quality of life and HF symptoms will be assessed using the Minnesota Living with Heart Failure (MLWHF) questionnaire, which is used as a standardised measure of self-reported health status, and HF symptoms and is considered to have a good discriminatory power and validity

OTHER

Assessment of sarcopenia

Participants will be assessed for presence of sarcopenia using the Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls (SARC-F) questionnaire. It is a robust tool for diagnosis of sarcopenia and prediction poor physical function, with excellent specificity in multimorbid individuals.

OTHER

Assessment of frailty

Frailty will be assessed using the Edmonton Frail Scale (EFS). The EFS is a multidimensional frailty assessment which assesses multiple domains of frailty including functional independence, social support, cognition, medication use, and mood.

OTHER

Qualitative interview

Participants in the MRP and control groups will be invited to attend a focused semi-structured, 1-2-1 interview aimed to elicit barriers and enablers to the MRP and describe their perspective on the relationship between healthy eating and health interview during the 12-week visit. Participants who complete or drop out will be eligible. Inclusion of participants in the control arm will allow us to compare the experiences of MRP versus health coaching and detect any specific issues people face when trying to introduce lifestyle changes themselves.

Trial Locations (3)

LE3 9QP

RECRUITING

University of Leicester, Glenfield Hospital, Groby Road, Leicester

M23 9LT

RECRUITING

University of Manchester, Wythenshawe Hospital, Southmoor Road, Manchester

OX3 9DU

RECRUITING

University of Oxford, John Radcliffe Hospital, Headley Way, Oxford

All Listed Sponsors
collaborator

University of Oxford

OTHER

collaborator

University of Manchester

OTHER

collaborator

University of Leeds

OTHER

lead

University of Leicester

OTHER