Heart failure & cardiomyopathiesRandomised controlled trial
Randomized Trial of a Selective Aldose Reductase Inhibitor in Patients With Diabetic Cardiomyopathy
- Randomised controlled trial
- placebo-controlled
- stratified
Authors' conclusion
Among individuals with DbCM and impaired exercise capacity, treatment with AT-001 for 15 months did not result in significantly better exercise capacity compared with placebo.
Study context
- Population
- Individuals with diabetic cardiomyopathy (DbCM) and reduced peak Vo2
- Participants
- 691 individuals
- Comparison
- AT-001 vs placebo
- Primary endpoint
- Proportional change in peak Vo2 from baseline
- Follow-up
- 15 months
Primary result
Change in peak Vo2
Difference
0.30
P = 0.19
By group
Placebo
−0.31
mL/kg/min
High-dose AT-001
−0.01
mL/kg/min
As reported in the abstract
Further findings
| Outcome | difference (mL/kg/min) | P value |
|---|---|---|
| Peak Vo2, no SGLT2 inhibitor or GLP-1 receptor agonist at baseline (prespecified subgroup) · 15 months | 0.62 | P = 0.04 |
- Peak Vo2, no SGLT2 inhibitor or GLP-1 receptor agonist at baseline (prespecified subgroup): interaction P = 0.10
Original publication
Randomized Trial of a Selective Aldose Reductase Inhibitor in Patients With Diabetic Cardiomyopathy. J Am Coll Cardiol. Published 8 April 2024. doi:10.1016/j.jacc.2024.03.380
Summarised from the published abstract; every number is checked against it