Table 2.

Trial outcomes

End PointaTreatmentBaseline12 moTreatment Difference Between Groupsf
EF (%)Control58.7±8.557.6±8.51.5 (−4.3 to 7.3)
Intervention57.4±15.361.0±18.4
LV mass (g)Control140.3±48.7141.3±48.7−15.6 (−29.4 to −1.9)
Intervention157.9±50.5145.6±50.5
LV mass indexed to BSA (g/m2)Control72.4±21.773.5±31.7−8.1 (−15.5 to −0.8)
Intervention80.7±17.875.0±26.5
Global peak systolic strain (%)bControl−16.3±3.7−13.0±6.9−3.3 (−6.5 to −0.2)
Intervention−15.9±4.6−15.9±7.6
Global peak systolic strain rate (s−1)cControl−0.97±0.2−0.87±0.21−0.2 (−0.3 to −0.08)
Intervention−1.02±0.3−1.03±0.25
Global peak diastolic strain rate (s−1)dControl1.05±0.30.90±0.420.18 (0.02 to 0.34)
Intervention1.12±0.41.00±0.41
LV end-diastolic volume (ml)Control150.3±37156.1±37−23.8 (−44.7 to −2.9)
Intervention162.9±39.8144.5±39.8
LV end-diastolic volume indexed to BSA (ml/m2)Control78.8±21.275.6±31.2−12.4 (−23.2 to −1.5)
Intervention83.5±2773.3±29.1
Aortic distensibility (mmHg−1×10−3)eControl4.4±2.62.1±2.61.8 (0.1 to 3.6)
Intervention3.4±2.53.1±2.5
  • EF, left ventricular ejection fraction; LV, left ventricle; BSA, body surface area.

  • a Mean±SD of observed values were adjusted using a linear mixed-effects model for study center, age, sex, and diabetes status.

  • b Systolic strain values are conventionally expressed on a negative scale as a percentage change in LV length from baseline, with more negative changes denoting better systolic function.

  • c Systolic strain rate values are expressed on a negative scale, with more negative changes denoting better systolic function.

  • d Diastolic strain rate values are a measure of diastolic function, with greater values denoting better function.

  • e Aortic distensibility data were skewed and therefore logarithmically transformed values were used, with coefficients back-transformed for presentation.

  • f Treatment effects are expressed as mean (95% CI) and were determined by the interaction of treatment group with time.