The effect of statins on circulating concentrations of the hormone C-type natriuretic peptide

Phase 1

Completed

• Conditions: Atherosclerosis; Cardiovascular - Coronary heart disease; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12613000525785
• Lead Sponsor: Christchurch Heart Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-13
• Study Completion: 2018-02-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 65

Inclusion Criteria

Group 1; Males aged 20-25y. No family history (1st and 2nd degree relatives) of coronary artery disease (CAD), stroke or peripheral vascular disease (PVD). No personal history of high BP, smoking, diabetes, lipid disorders or renal disease. BMI between 18-25. Normal BP (<140 systolic, <90 diastolic). Normal Blood lipid profile.
Group 2; Males aged 40-60y. No family history (1st and 2nd degree relatives) of CAD, stroke or PVD. No personal history of high BP, smoking, diabetes, lipid disorders or renal disease. BMI between 18-25. Normal BP (<140 systolic, <90 diastolic). Normal Blood lipid profile.
Group 3; Males diagnosed with overt coronary artery disease aged 40-60y about to start statin therapy. Allow family history of CAD, stroke or PVD. Allow personal history of high BP, lipid disorder.

Exclusion Criteria

Unwilling or unable to give informed consent.
Groups 1 & 2; On medication. BMI > 25. Systolic BP >140, Diastolic BP >90. Triglycerides >1.7mmol/L.
Group 3; Subjects who have previously taken statin medication. Subjects with past episodes of heart failure, diabetics receiving insulin, raised plasma creatinine (> 110umol/L) and metabolic bone disease or recent fracture.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analyse the relative changes in plasma concentrations of NTproCNP following statin treatment in the three groups. Group 1; twenty healthy fit young adult males aged 20 – 25 years. Group 2; twenty healthy fit older adult males aged 40-60 years with no history (or family history) of cardiovascular disease. Group 3; Twenty male patients recently diagnosed with overt coronary artery disease aged 40-60 year about to start statin drug therapy.[Baseline, Days 1, 2 and 7 of statin treatment (Groups 1,2 and 3). Months 1-6 of statin treatment for Group 3. ]

Secondary Outcome Measures

Name	Time	Method
Determine the relationship of plasma NTproCNP concentrations to plasma lipid markers and high sensitivity C reactive protein. [Baseline, Days 1, 2 and 7 of statin treatment (Groups 1,2 and 3). Months 1-6 of statin treatment for Group 3. ]