Effect of Statin Use on Aldosterone Secretion
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 2/20/2019 |
| Start Date: | April 2016 |
| End Date: | December 2020 |
| Contact: | Cara Ludwick |
| Email: | cludwick1@partners.org |
| Phone: | 617-278-0305 |
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.
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.
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 (3 months) therapy of the two statin medications.
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 (3 months) therapy of the two statin medications.
Inclusion Criteria:
- Blood pressure <140/90 mmHg and >100/50 mmHg
- Body mass index 27-40 kg/m2
- Normal screening laboratory values for:
i. Serum sodium, potassium, glucose, liver enzymes ii. GFR (>60 mL/min/1.73m2) iii.
A1c iv. TSH
- Normal ECG
- Negative urine HCG at screening for women who are able to become pregnant.
Exclusion Criteria:
- Any prior use of statin therapy
- History of coronary disease, diabetes, hypertension, stroke, kidney disease, thyroid
disease, psychiatric illness, malignancy, preeclampsia, or illness requiring overnight
hospitalization in the past 6 months
- Triglycerides > 500, LDL > 200
- Any prescription medication or herbal medication including oral contraceptive
- Pregnancy or current breastfeeding
- Alcohol intake >12 oz per week
- Tobacco or recreational drug use
We found this trial at
1
site
Boston, Massachusetts 02115
Principal Investigator: Jonathan Williams, MD
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