Hemodialysis Clinical Trial
— THYROID-HDOfficial title:
A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients
NCT number | NCT03977207 |
Other study ID # | 20195142 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 20, 2020 |
Est. completion date | April 30, 2025 |
Hypothyroidism, defined by elevated thyrotropin (TSH) levels, is a common endocrine complication in chronic kidney disease patients, and prior evidence shows that higher TSH levels, even within the normal laboratory range, are strongly associated with impaired quality of life and cardiovascular disease in this population. Levothyroxine is one of the most frequently prescribed medications in chronic kidney disease, yet its efficacy and safety in these patients have not been well-studied. Hence, this study will investigate 1) whether levothyroxine improves patient-centered (e.g., health-related quality of life, physical performance, strength) and 2) cardiovascular (e.g., coronary artery calcification, endothelial function, systolic function) outcomes in dialysis patients, and 3) if thyroid hormone replacement exerts classic metabolic effects (i.e., changes in body fat and resting energy expenditure) in this population.
Status | Recruiting |
Enrollment | 336 |
Est. completion date | April 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age 18-75 years old - Received hemodialysis at least four weeks - Have two consecutive thyrotropin (TSH) levels >3.0-10.0mIU/L during the screening period - Have normal free thyroxine (FT4) levels - Have ability to provide written informed consent Exclusion Criteria: - Active treatment with thyroid hormone supplementation or anti-thyroid medications - Active receipt of dialysis - Prior kidney transplantation - Life expectancy less than six months - Active malignancy or prior thyroid malignancy - Active pregnancy or planning a pregnancy - Active coronary ischemia or atrial fibrillation (evaluated by EKG) - Active congestive heart failure exacerbation - Osteoporosis - Weight in excess of 450 lbs. - Hyperthyroidism as determined by TSH <0.5mIU/L during the screening period, anti-thyroid medication use, or hyperthyroidism diagnosis |
Country | Name | City | State |
---|---|---|---|
United States | University of California Irvine | Orange | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Irvine | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Rhee CM, Alexander EK, Bhan I, Brunelli SM. Hypothyroidism and mortality among dialysis patients. Clin J Am Soc Nephrol. 2013 Apr;8(4):593-601. doi: 10.2215/CJN.06920712. Epub 2012 Dec 20. — View Citation
Rhee CM, Chen Y, You AS, Brunelli SM, Kovesdy CP, Budoff MJ, Brent GA, Kalantar-Zadeh K, Nguyen DV. Thyroid Status, Quality of Life, and Mental Health in Patients on Hemodialysis. Clin J Am Soc Nephrol. 2017 Aug 7;12(8):1274-1283. doi: 10.2215/CJN.13211216. Epub 2017 Jul 13. — View Citation
Rhee CM, Kalantar-Zadeh K, Ravel V, Streja E, You AS, Brunelli SM, Nguyen DV, Brent GA, Kovesdy CP. Thyroid Status and Death Risk in US Veterans With Chronic Kidney Disease. Mayo Clin Proc. 2018 May;93(5):573-585. doi: 10.1016/j.mayocp.2018.01.024. — View Citation
Rhee CM, Kim S, Gillen DL, Oztan T, Wang J, Mehrotra R, Kuttykrishnan S, Nguyen DV, Brunelli SM, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Association of thyroid functional disease with mortality in a national cohort of incident hemodialysis patients. J Clin Endocrinol Metab. 2015 Apr;100(4):1386-95. doi: 10.1210/jc.2014-4311. Epub 2015 Jan 29. — View Citation
Rhee CM, Ravel VA, Streja E, Mehrotra R, Kim S, Wang J, Nguyen DV, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Thyroid Functional Disease and Mortality in a National Peritoneal Dialysis Cohort. J Clin Endocrinol Metab. 2016 Nov;101(11):4054-4061. doi: 10.1210/jc.2016-1691. Epub 2016 Aug 15. — View Citation
Rhee CM, You AS, Nguyen DV, Brunelli SM, Budoff MJ, Streja E, Nakata T, Kovesdy CP, Brent GA, Kalantar-Zadeh K. Thyroid Status and Mortality in a Prospective Hemodialysis Cohort. J Clin Endocrinol Metab. 2017 May 1;102(5):1568-1577. doi: 10.1210/jc.2016-3616. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Health-Related Quality of Life (HRQOL) - Short Form 36 Physical Component Score | We will assess HRQOL using the Short Form 36, which consists of 36 questions grouped into eight subscales (score 0-100 for each subscale; higher scores indicate better states of health) that will be used to derive a summary Physical Component Score. | Week 0 (pre-trial/baseline) | |
Primary | Health-Related Quality of Life (HRQOL) - Short Form 36 Physical Component Score | We will assess HRQOL using the Short Form 36, which consists of 36 questions grouped into eight subscales (score 0-100 for each subscale; higher scores indicate better states of health) that will be used to derive a summary Physical Component Score. | Week 12 | |
Primary | Health-Related Quality of Life (HRQOL) - Short Form 36 Physical Component Score | We will assess HRQOL using the Short Form 36, which consists of 36 questions grouped into eight subscales (score 0-100 for each subscale; higher scores indicate better states of health) that will be used to derive a summary Physical Component Score. | Week 24 | |
Primary | Coronary Artery Calcification (CAC) - Volume Score | We will assess CAC Volume Score using a 256-multidetector CT test. Volume score will be calculated by multiplying the number of voxels with calcification by the volume of each voxel for each calcified lesion, and summing individual lesion scores from the four main coronary arteries (left main, left anterior descending, circumflex, and right coronary artery). | Week 0 (pre-trial/baseline) | |
Primary | Coronary Artery Calcification (CAC) - Volume Score | We will assess CAC Volume Score using a 256-multidetector CT test. Volume score will be calculated by multiplying the number of voxels with calcification by the volume of each voxel for each calcified lesion, and summing individual lesion scores from the four main coronary arteries (left main, left anterior descending, circumflex, and right coronary artery). | Week 24 | |
Secondary | Thyroid-Specific HRQOL - ThyPRO Hypothyroid Symptoms and Tiredness Domain Scores | We will administer the thyroid-specific quality of life patient-reported outcome (ThyPRO) measure, which is comprised of 84 items categorized into 13 domains, plus a general quality of life question (this is a composite measure). | Weeks 0 (pre-trial/baseline) and 24 (post-randomization) | |
Secondary | Physical Performance - Short Physical Performance Battery (SPPB) | We will measure physical performance using the Short Physical Performance Battery (SPPB), which tests 1) gait speed (faster of two timed, usual pace 15-foot walks), 2) balance (balance test measuring ability to stand with feet in side-by-side, semi-tandem, and tandem positions for 10 seconds), and 3) chair raises (timed series of five attempts to arise from a chair unassisted without use of arms), with each component ranging from 0 to 4 (score 0-12; higher score indicates better performance). | Weeks 0 (pre-trial/baseline) and 24 (post-randomization) | |
Secondary | Endothelial Function - Digital Thermal Monitor | We will measure endothelial function using digital thermal monitor (DTM) testing, which is based on the principle that changes in fingertip temperature during and after an ischemic stimulus (blood pressure [BP] cuff occlusion) reflect changes in blood flow. In normal endothelial function, cuff inflation results in a 1-3 degree Celsius temperature decline, followed by rapid temperature rise to above baseline during cuff deflation due to compensatory vasodilation. Temperature (temp) will be measured before, during, and after a 2-minute BP cuff inflation in the non-vascular access arm in order to measure Area Under the Temp Curve (TMP-AUC), defined as area under the curve between the maximum and minimum temp. | Weeks 0 (pre-trial/baseline) and 24 (post-randomization) | |
Secondary | Vascular Calcification Inhibitor - Matrix Gla Protein Levels | We will use plasma collected during hemodialysis treatments to measure total uncarboxylated matrix Gla protein levels. Assays will be conducted in the University of California Irvine Institute of Clinical Translational Science Bioassay Core. | Weeks 0 (pre-trial/baseline) and 24 (post-randomization) | |
Secondary | Total Body Fat Percentage | We will assess total body fat percentage using Dual Energy X-Ray absorptiometry. | Weeks 0 (pre-trial/baseline) and 24 (post-randomization) | |
Secondary | Muscle Strength - Isometric Dynamometry | We will assess muscle strength using BioDex dynamometry, which will be used to measure Isometric Quadriceps Maximal Strength (Peak Torque, Newton-meters), in which patients will perform three maximal knee-extension efforts at a knee angle of 60 degrees using the dominant leg; each trial consists of a repetition of five seconds of concentric quadriceps contraction, followed by at least 90-seconds of resting recovery. | Weeks 0 (pre-trial/baseline) and 24 (post-randomization) | |
Secondary | Systolic Function - Global Longitudinal Strain | We will measure systolic function using Global Longitudinal Strain (GLS) using speckle-tracking 2D-echocardiography, which measures the contraction/deformation of myocardium during systole and is represented by a negative value (i.e., more negative GLS indicates better function). | Weeks 0 (pre-trial/baseline) and 24 (post-randomization) | |
Secondary | Resting Energy Expenditure (REE) - Indirect Calorimetry | We will measure REE using indirect calorimetry, in which following an overnight fast, patients will undergo a 20-minute resting period, after which oxygen consumption and carbon dioxide expiration will be recorded for 20-minutes while remaining under resting conditions, which will be used to calculate REE using the Weir formula. | Weeks 0 (pre-trial/baseline) and 24 (post-randomization) |
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