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Clinical Trials: Hormone
IRB No. 24-132-2 (Dr. Tarunya Vedere, PI): Primary Hyperaldosteronism is a Risk Factor for Developing Hypertensive Disorders of Pregnancy
This study is divided into 2 groups: study and control. The study group includes patients with a diagnosis of high blood pressure before, during or immediately after pregnancy [hypertensive disorder of pregnancy (HDP)] and the control group includes patients who do not have a diagnosis of high blood pressure around the time of pregnancy. This research is being done to determine if underlying excessive aldosterone hormone production [Primary Hyperaldosteronism (PA)] is a pre-pregnancy risk factor for HDP. HDP complicates about 10% of pregnancies and can cause a lifetime risk of developing chronic hypertension and cardiovascular disease (also called heart disease). PA occurs due to a problem of the adrenal glands (located on top of both kidneys) and is an underdiagnosed cause of hypertension (high blood pressure). Hyperaldosteronism happens when the adrenal glands release too much aldosterone hormone, leading to sodium retention, high blood pressure and low potassium levels. In this study, the researchers will assess if women with history of HDP have higher production of aldosterone compared to women without history of HDP. This will be done by testing blood and urine samples.
IRB No. 24-186-1 (Dr. Francesco Celi, PI): Novel approaches to the treatment of hypothyroidism
Hypothyroidism is a common disease affecting up to 10% of the adult population, disproportionally more frequent in females. This condition is associated with dyslipidemia and increased cardiovascular risk1-4, which is not completely reversed following therapy. Despite its prevalence, there is a surprising lack of evidence-based information on the optimal treatment of hypothyroidism, likely because thyroid hormone replacement treatments have been in place well before the establishment of the current regulatory framework. This is a randomized, three-arm, double-blind, controlled, escalating dose parallel pilot study in which 90 patients with hypothyroidism (30 each group) will be randomized to six months of treatment with LT4/placebo, LT4/LT3 with LT3 administered once daily, or LT4/LT3 with LT3 administered twice daily. This study will identify information on feasibility, dosing, treatment scheme, and effect size of end-organ outcomes. If successful, this will inform future clinical trials that will provide evidence supporting or negating the use of LT4/LT3 combination therapy to treat hypothyroidism.