Effect of Statin Use on Aldosterone Secretion

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Healthy Subjects

Clinical Trial Details

NCT number	NCT02871687
Study type	Interventional
Source	Brigham and Women's Hospital
Contact
Status	Completed
Phase	Phase 1
Start date	April 2016
Completion date	March 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05483998` - A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants	Phase 1
Recruiting	`NCT02417714` - Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Recruiting	`NCT02235012` - Cognitive Biases Under Ketamine	N/A
Completed	`NCT04418973` - Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject.	N/A
Completed	`NCT05088343` - Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects	Phase 1
Not yet recruiting	`NCT06248801` - Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets	Phase 1
Terminated	`NCT04068259` - Single Ascending Dose Study of PBI-4547 in Healthy Subjects	Phase 1
Completed	`NCT03279302` - Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects	Phase 1
Not yet recruiting	`NCT06233162` - Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets	Phase 1
Recruiting	`NCT04159844` - Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects	N/A
Completed	`NCT06137911` - Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults.	Phase 1
Completed	`NCT04849286` - Measurement of HTL0016878 in Cerebrospinal Fluid	Phase 1
Not yet recruiting	`NCT06233227` - Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule	Phase 1
Completed	`NCT04096157` - A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants	Phase 1
Completed	`NCT01200368` - Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants	Phase 3
Recruiting	`NCT05805033` - Peri-Implant Soft Tissue Integration in Humans: Influence of Material	N/A
Completed	`NCT04027803` - Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®	Phase 1
Recruiting	`NCT03467880` - Multicenter Study of Impulse Oscillometry in Chinese	N/A
Completed	`NCT02903095` - Single Ascending Dose Study of TD-1439 in Healthy Subjects	Phase 1
Active, not recruiting	`NCT02341508` - A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers	Phase 1