Improving Arterial Wall Characteristics in Patients After Myocardial Infarction With a Very Low Dose of Fluvastatin and Valsartan: Proof-of-concept Study

NCT03309618 NA COMPLETED

The concept of improving arterial wall characteristics by treatment with a very low-dose combination of fluvastatin and valsartan (low-flu/val) in stable, post-myocardial infarction (MI) patients was tested. The parameters of endothelial function (flow mediated dilatation (FMD), reactive hyperemia index) and arterial stiffness (carotid-femoral pulse wave velocity (cf-PWV), local carotid PWV and β-stiffness coefficient) were measured before and after 30 days of treatment, and the residual effect was assessed 10 weeks later. So the investigators explored whether low-flu/val added "on-top-of" optimal therapy could improve endothelial function and arterial stiffness in post-MI patients. Since these improved parameters are well-known predictors of future coronary events, such treatment could decrease cardiovascular risk.

Details

Lead sponsor	University Medical Centre Ljubljana
Phase	NA
Status	COMPLETED
Enrolment	36
Start date	2012-11
Completion	2014-11

Conditions

• Myocardial Infarction

Interventions

• low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val)
• placebo

Primary outcomes

• brachial flow mediated dilatation (FMD) — 30 days
  ultrasonographically measured flow mediated dilatation of brachial artery
• carotid pulse wave velocity (c-PWV) — 30 days
  ultrasonographically measured pulse wave velocity of carotid artery
• β-stiffness coefficient — 30 days
  ultrasonographically measured β-stiffness coefficient of carotid artery
• carotid-femoral pulse wave velocity (cf-PWV) — 30 days
  carotid-femoral pulse wave velocity measured by Sphygmocor
• reactive hyperemia index (RHI) — 30 days
  reactive hyperemia index measured by an Endopat device

Countries

Slovenia