Brigham and Women's Hospital- 221 Longwood Avenue
Boston, Massachusetts, 02115, United States
NCT Number: NCT02871687
The purpose of this research protocol is to determine if the same effects are observed in vivo in humans through a randomized controlled study. Data regarding a novel mechanism of the widely used statin class of medications on the mineralocorticoid pathway would likely have significant clinical implications on the future management of hypertension and other cardiovascular disease given the known pleiotropy of aldosterone action.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 1
Boston, Massachusetts, 02115, United States
In order to provide additional evidence regarding the effect of statin therapy on aldosterone levels, the investigators propose the following randomized, double-blinded, placebo controlled protocol in relatively healthy volunteers. The investigators will evaluate aldosterone and cortisol production in response to an angiotensin II infusion under the following test conditions: 1) placebo, 2) simvastatin therapy (lipophilic statin), and 3) pravastatin therapy (hydrophilic statin). Measurements will be made to assess the effect of both acute (single dose) and chronic (6 and 12 weeks) therapy of the two statin medications.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
i. Serum sodium, potassium, glucose, liver enzymes ii. GFR (>60 mL/min/1.73m2) iii. A1c iv. TSH
Exclusion criteria
Simvastatin 20 mg daily followed by potential increase to 40 mg simvastatin according to dose escalation procedure
Other names: Zocor
Pravastatin 40 mg daily followed by potential increase to 80 mg pravastatin according to dose escalation procedure
Other names: Pravachol
Placebo prepared by Investigation Drug Services at Brigham and Women's Hospital
Time frame: 3 months
Time frame: Baseline
Time frame: 3 months
Brigham and Women's Hospital
Other
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