None listed
Conditions
Brief summary
Heart failure is one of the most common complications of diabetes. This illness is preventable in the early stages, but few people are detected early enough for prevention to be effective. This trial will identify early stage heart failure using a new Artificial Intelligence (AI) process, and then seek whether exercise training and protective medications can prevent deterioration of function. Hypothesis: The use of exercise training and protective medications in "at risk" patients with diabetes (identified by a new Artificial Intelligence (AI) process) can prevent deterioration of exercise capacity.
Interventions
The multidisciplinary cardio-protective intervention over 2 years will be characterized by;
1) Baseline assessment of clinical risk using questionnaires, ECG and echo provided by the study nurses, co-ordinators and sonographers
2) Optimizing medical management. This will involve addition of cardioprotective therapy not already in use by these participants - including ACE/ARB, SGLT2 inhibitors and mineralocorticoid antagonists, delivered orally after dispensing in the community. The choice and do
The multidisciplinary cardio-protective intervention over 2 years will be characterized by; 1) Baseline assessment of clinical risk using questionnaires, ECG and echo provided by the study nurses, co-ordinators and sonographers 2) Optimizing medical management. This will involve addition of cardioprotective therapy not already in use by these participants - including ACE/ARB, SGLT2 inhibitors and mineralocorticoid antagonists, delivered orally after dispensing in the community. The choice and dosage of agents will be individualized by the medical supervisors of each site in conjunction with the patient's GP, based on participants' responses (eg. blood pressure, renal function). Target doses will be ramipril 10 mg/d, candesartan 32 mg/d, spironolactone 25 mg/d or dapagliflozin 10 mg/d - or dose-equivalents of other compounds in each class. Adherence will be monitored by scripts filled and pill-counts. 3) Exercise intervention. This will involve strength (eg. weights) and aerobic training (eg. stationary bike) for 30 minutes three times each week, of moderate intensity, judged by rating on the Borg RPE scale, based on individual prescription by an accredited exercise physiologist involved with the study. This will be delivered at the study site or remotely, dependent on the circumstances of the participant. Adherence will be documented by the supervising exercise physiologist.
Sponsors
University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Men and women >65 years with T2DM but no diagnosis of HF, in sinus rhythm
Exclusion criteria
1) HF - documented or undiagnosed (EF 400ng/l). 2) Other cardiac disease (myocardial infarction, angina, >70% coronary stenoses, more than moderate valve disease). 3) already in a supervised exercise program. 4) features incompatible with RCT (unlikely to be adherent with study follow-up; <12 months life expectancy due to concomitant disease; participation in another clinical research trial where blinded treatment would be unacceptable; unable to provide written informed consent); 5) inability to acquire interpretable echo images (uncommon)
Outcome results
None listed