CompletedEarly Phase 1ACTRN12613000525785

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

A study to assess NTproCNP as a new potential biomarker of atheroma risk and/or severity through clinical studies of blood samples from donors starting statin drug therapy including healthy donors and those with overt coronary artery disease.

Sponsor

Christchurch Heart Institute

Enrollment

60 participants

Start Date

Aug 20, 2013

Study Type

Interventional

Conditions

Atherosclerosis

Summary

The purpose of this study is to test a new potential marker of atheroma risk and/or severity – aminoterminal C-type natriuretic peptide (NTproCNP). We will follow longitudinally the changes in blood concentrations of NTproCNP in response to the statin, Atovastatin, in healthy male volunteers and male patients who have just been diagnosed with overt coronary artery disease and are about to start statin drug therapy. Three groups of volunteers will be studied, all of whom will not have previously received statin treatment:- Group 1; 20 normal, healthy male volunteers aged between 20-25 years. Group 2; 20 normal, healthy male volunteers aged between 40-60 years. Group 3; 20 male patients aged between 40-60 years recently diagnosed with overt coronary artery disease and about to start statin drug therapy. All subjects will receive statin therapy for one week but group 3 subjects will continue thereafter for a period of at least 6 months. An overnight fasted blood sample will be obtained from all subjects immediately prior to receiving Atovastatin 40mg daily. Additional overnight fasted blood samples will be drawn from all subjects on days 1, 2 and 7 following initiation of statin therapy. Further monthly blood samples will be obtained from group 3 subjects for 6 months. Blood samples will be analysed for lipids (triglycerides, total cholesterol, LDL and HDL), creatinine, high sensitivity C reactive protein (hsCRP), CNP and NTproCNP content.

Eligibility

Sex: MalesMin Age: 20 YearssMax Age: 60 Yearss

Inclusion Criteria3

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 Criteria3

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.

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Interventions

Three subject groups will be recruited. Group 1; twenty healthy fit young adult males aged 20 – 25 years, free of cardiovascular risk factors and with no family history of cardiovascular disease. 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. None of the subjects in each of the three groups shall have received prior statin therapy. All subjects will receive statin therapy for one week but group 3 subjects will continue thereafter for a period of at least 6 months. An overnight fasted blood sample will be obtained at 0800hrs from all subjects immediately prior to receiving Atovastatin 40mg daily (oral tablet). Additional overnight fasted blood samples will be drawn from all subjects at 0800hrs on days 1, 2 and 7 following initiation of statin therapy. Adherence to drug schedule will be assessed by drug tablet return. Further monthly blood samples will be obtained from group 3 subjects for 6 months. Blood samples will be analysed for lipids (triglycerides, total cholesterol, LDL and HDL), creatinine, high sensitivity C reactive protein (hsCRP), CNP and NTproCNP content. Subjects in groups 1 and 2 with baseline triglyceride > 1.7 mmol/L will be excluded.