Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Recruitment and retention rates |
The number of people approached, recruited and retained |
16 weeks |
|
Secondary |
Differences in 6 minute walk test pre- and post intervention |
Meters walked within 6 minutes |
12 weeks |
|
Secondary |
Differences in cardiopulmonary exercise test (peak VO2) pre- and post intervention |
exercise test on a static bike using minute by minute ventilatory gas analysis |
12 weeks |
|
Secondary |
Differences in LV remodelling (indexed LV mass) pre- and post intervention |
CMR measures of cardiac geometry |
12 weeks |
|
Secondary |
Differences in LV function pre- and post intervention |
CMR measures of cardiac function |
12 weeks |
|
Secondary |
Differences in E/A ratio pre- and post intervention |
Standard clinical echocardiography |
12 weeks |
|
Secondary |
Differences in E (cm/s) pre- and post intervention |
Standard clinical echocardiography |
12 weeks |
|
Secondary |
Differences in MV deceleration time (ms) pre- and post intervention |
Standard clinical echocardiography |
12 weeks |
|
Secondary |
Differences in A (cm/s) pre- and post intervention |
Standard clinical echocardiography |
12 weeks |
|
Secondary |
Differences in Septal e' pre- and post intervention |
Standard clinical echocardiography |
12 weeks |
|
Secondary |
Differences in Lateral e' pre- and post intervention |
Standard clinical echocardiography |
12 weeks |
|
Secondary |
Differences in Septal E/e' pre- and post intervention |
Standard clinical echocardiography |
12 weeks |
|
Secondary |
Differences in Lateral E/e' pre- and post intervention |
Standard clinical echocardiography |
12 weeks |
|
Secondary |
Differences in Average E/e' pre- and post intervention |
Standard clinical echocardiography |
12 weeks |
|
Secondary |
Differences in LA volume indexed pre- and post intervention |
Standard clinical echocardiography |
12 weeks |
|
Secondary |
Differences in TR jet velocity (m/s) pre- and post intervention |
Standard clinical echocardiography |
12 weeks |
|
Secondary |
Differences in BMI pre- and post intervention |
Weighing scales and stadiometer measurement (Kg/m2) |
12 weeks |
|
Secondary |
Differences in Bone Mineral Density (g/cm2) pre- and post intervention |
DEXA scan |
12 weeks |
|
Secondary |
Differences in Total Fat mass (g) pre- and post intervention |
DEXA scan |
12 weeks |
|
Secondary |
Differences in Total tissue fat (%) pre- and post intervention |
DEXA scan |
12 weeks |
|
Secondary |
Differences in visceral adipose tissue mass (g) pre- and post intervention |
DEXA scan |
12 weeks |
|
Secondary |
Differences in visceral adipose tissue volume (cm3) pre- and post intervention |
DEXA scan |
12 weeks |
|
Secondary |
Differences in Total lean body mass (g) pre- and post intervention |
DEXA scan |
12 weeks |
|
Secondary |
Difference in World Health Organisation Disability Schedule (WHODAS 2.0) pre- and post intervention |
Scale 0 - 48 with lower scores indicating better outcome |
12 weeks |
|
Secondary |
Difference in Medical Research Council Dyspnoea Scale pre- and post intervention |
scale 1 - 5 with lower scores indicating better outcome |
12 weeks |
|
Secondary |
Difference in Minnesota Living with heart Failure Questionnaire pre- and post intervention |
Scale 0 - 105 with lower scores indicating better outcome |
12 weeks |
|
Secondary |
Differences in Fasting Glucose (mmol/L) pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in HbA1c (%) pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in HbA1c (mmol/mol) pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in B-type (ng/L) natriuretic peptide pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in hs-troponin (ng/L) natriuretic peptide pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in CRP (mg/L), natriuretic peptide pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in albumin concentration pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in albumin/creatinine ratio concentration pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in sodium (mmol/L) pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in potassium (mmol/L) pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in Urea (mmol/L) pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in creatinine (umol/L) pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in eGFR (ml/min) pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in hsTnl(ng/L) pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in hALT (iu/L) pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in ALP (iu/L)pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in LDL (mmol/L) pre- and post intervention |
Biochemistry |
12 weeks |
|
Secondary |
Differences in kidney function pre- and post intervention |
Blood analysis for eGFR (ml/min) |
12 weeks |
|
Secondary |
Differences in liver function pre- and post intervention |
Blood analysis for ALP (iu/L) |
12 weeks |
|
Secondary |
Differences in the levels of physical activity pre- and post intervention |
Objectively measured with an accelerometer |
12 weeks |
|
Secondary |
Cardiac rehabilitation uptake |
The proportion of participants who were offered and attended cardiac rehabilitation following completion of the intervention (%) |
12 months |
|
Secondary |
The number of participants who experience any Major Adverse Cardiovascular Events (MACE) |
At any point during the study if a participant experiences a major cardiovascular event this will be recorded and reported to sponsor in line with handling serious adverse events |
12 weeks |
|