Abstract: SA-PO430
Rationale and Design of the NIH THYROID-HD Trial: A Randomized Controlled Trial of Thyroid Hormone Supplementation in Patients on Hemodialysis
Session Information
- Hemodialysis and Frequent Dialysis - 2
October 26, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Narasaki, Yoko, University of California Los Angeles, Los Angeles, California, United States
- Daza Aguilar, Andrea C., University of California Los Angeles, Los Angeles, California, United States
- Novoa Vargas, Alejandra, University of California Los Angeles, Los Angeles, California, United States
- You, Amy Seungsook, University of California Los Angeles, Los Angeles, California, United States
- Kalantar-Zadeh, Kamyar, Harbor-UCLA Medical Center, Torrance, California, United States
- Nguyen, Danh V., University of California Irvine, Irvine, California, United States
- Rhee, Connie, University of California Los Angeles, Los Angeles, California, United States
Background
Hypothyroidism is a highly prevalent yet under-recognized endocrine complication in CKD patients, affecting ~25% of those receiving dialysis. Prior evidence shows that higher TSH levels, even within the normal laboratory range, are strongly associated with impaired HRQOL and CV disease in this population. While levothyroxine is one of the most frequently prescribed medications in dialysis patients, its efficacy and safety in this population have not been well-studied.
Methods
The multi-center NIH THYROID-HD Trial is a randomized double-blind placebo-controlled trial enrolling dialysis patients with high-normal or subclinical hypothyroid range TSH levels to determine the effects of 24 weeks of levothyroxine vs. placebo on HRQOL assessed by the Short Form 36 and coronary artery calcification (co-primary endpoints). The main secondary endpoints include assessment of HRQOL measured by the ThyPRO survey, physical performance, endothelial function, vascular calcification inhibitors, and total body fat. A subcohort of patients are also undergoing exploratory endpoints of muscle strength, systolic function, and resting energy expenditure (Figure 1).
Results
The THYROID-HD Trial’s enrollment target is 336 patients, based on an anticipated 10% attrition rate. Among 242 patients recruited and randomized thus far, baseline characteristics show that the mean ± SD age is 54±13 years old; 42% are female; 9%, 6%, 3%, 80%, and 3% are of Asian, Black, NHOPI, White, or Other race; 75% are of Hispanic ethnicity; and 71% vs. 29% have TSH levels in the high-normal vs. subclinical hypothyroid range.
Conclusion
The THYROID-HD Trial will determine the effects of thyroid hormone replacement on patient-reported outcomes, CV endpoints, and metabolic health in dialysis patients with high-normal or subclinical hypothyroid range TSH levels, and inform the management of this prevalent endocrine complication in ESKD patients.
Funding
- NIDDK Support