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A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients

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Hol
Orange (Egyesült Államok)A helyszín megnézése

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Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 75 év között vagy?

Forrás: NCT03977207: ki vehet részt

Helyszínek itt: Egyesült Államok

  • University of California IrvineOrange, Egyesült ÁllamokContact: Kamyar Kalantar-ZadehRésztvevőt keres

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  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
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  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

A vizsgálat adatai

Ki végzi
University of California, Irvine
Azonosító
NCT03977207
A regiszteradat frissítve
2025. szeptember 8.
Eredeti leírás
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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: 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.

Kizáró feltételek: Active treatment with thyroid hormone supplementation or anti-thyroid medications; Prior kidney transplantation; Active malignancy or prior thyroid malignancy; Hyperthyroidism as determined by TSH <0.5mIU/L during the screening period, anti-thyroid medication use, or hyperthyroidism diagnosis; Active congestive heart failure exacerbation; Active receipt of dialysis; Life expectancy less than six months; Active pregnancy or planning a pregnancy; Active coronary ischemia or atrial fibrillation (evaluated by EKG); Osteoporosis; Weight in excess of 450 lbs.

ClinicalTrials.gov NCT03977207

Építés alatt, nem éles – A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients (NCT03977207) – Frontlight Research