Cardio Trial Files: Aldose Reductase Inhibitor for Diabetic Cardiomyopathy, Evinacumab for HoFH, and Home BP Telemonitoring + Nurse Case Management
Randomized Trial of a Selective Aldose Reductase Inhibitor in Patients With Diabetic Cardiomyopathy
Januzzi JL et al. JACC (July 2024)
Bottom Line: This randomized controlled trial, known as ARISE-HF, aimed to determine the efficacy of AT-001, a selective aldose reductase inhibitor, in stabilizing exercise capacity in individuals with diabetic cardiomyopathy and reduced peak oxygen uptake (Vo2). A total of 691 participants were randomized to receive either placebo or ascending doses of AT-001 twice daily for 15 months. The primary outcome was the proportional change in peak Vo2 from baseline to 15 months. The results showed no significant difference in exercise capacity between the placebo and high-dose AT-001 groups. Subgroup analyses also did not show a significant difference, except in those not receiving certain medications at baseline.
Evinacumab in homozygous familial hypercholesterolaemia: long-term safety and efficacy
Gaudet D et al. European Heart Journal (June 2024)
Bottom Line: This open-label, single-arm, Phase 3 trial assessed the long-term safety and efficacy of evinacumab in adult and adolescent patients with homozygous familial hypercholesterolaemia (HoFH). A total of 116 patients were enrolled and treated for a median duration of 104.3 weeks. Patients were treated with evinacumab 15mg/kg every 4 weeks with stable lipid-lowering therapy. Evinacumab significantly decreased LDL-C by 43.6% in the overall population, with sustained efficacy and safety over the long term. Treatment-emergent adverse events (TEAEs) and serious TEAEs were reported in 93 (80.2%) and 27 (23.3%) patients, respectively, with no deaths or discontinuations related to evinacumab. In conclusion, evinacumab was well tolerated and effectively decreased LDL-C in patients with HoFH.
Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke
Ogedegbe G et al. JAMA (June 2024)
Bottom Line: This practice-based, multicenter, randomized clinical trial enrolled 450 predominantly low-income Black and Hispanic stroke survivors with uncontrolled hypertension to determine the effectiveness of nurse case management (NCM) plus Home Blood Pressure Telemonitoring (HBPTM) compared to HBPTM alone. The intervention group received 20 counseling calls over 12 months in addition to 12 HBPTM per week for 12 months, while the comparator group only received the HBPTM. The primary outcome was change in systolic blood pressure at 12 months. The between-group difference in systolic blood pressure reduction at 12 months was −8.1 mm Hg (95% CI, −11.2 to −5.0; P < .001) at 12 months favoring NCM + HBPTM. The rate of recurrent stroke at 24 months was similar between both groups. The study suggests that NCM-enhanced telehealth programs may be beneficial for this patient population, but further research is needed to understand long-term outcomes and generalizability.
Cardio Trial Files Issue #CRD-2024-18
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