Clinical trial NCT03309618: Post- Myocardial Infarction Arterial Wall Improvement by Low-dose Fluvastatin and Valsartan
Official title: Improving Arterial Wall Characteristics in Patients After Myocardial Infarction With a Very Low Dose of Fluvastatin and Valsartan: Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: myocardial infarction
arterial stiffness
pulse wave velocity
flow mediated dilatation
fluvastatin
valsartan
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 36
Sex: MALE
Maximum age (years): 55
Standard ages: CHILD
ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* history of MI in the last 0.5 to 5 years
* males
* aged under 55 years

Exclusion Criteria:

* diabetes mellitus
* manifest peripheral artery disease or carotid artery disease
* acute infection
* chronic diseases
* present therapy with fluvastatin and/or valsartan.

Primary outcomes:
measure: brachial flow mediated dilatation (FMD)
timeFrame: 30 days
measure: carotid pulse wave velocity (c-PWV)
timeFrame: 30 days
measure: β-stiffness coefficient
timeFrame: 30 days
measure: carotid-femoral pulse wave velocity (cf-PWV)
timeFrame: 30 days
measure: reactive hyperemia index (RHI)
timeFrame: 30 days
Secondary outcomes:
measure: brachial flow mediated dilatation (FMD)
timeFrame: 10 weeks after termination of intervention
measure: carotid pulse wave velocity (c-PWV)
timeFrame: 10 weeks after termination of intervention
measure: β-stiffness coefficient
timeFrame: 10 weeks after termination of intervention
measure: carotid-femoral pulse wave velocity (cf-PWV)
timeFrame: 10 weeks after termination of intervention
measure: reactive hyperemia index (RHI)
timeFrame: 10 weeks after termination of intervention
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Department of Vascular Diseases, University Medical Centre Ljubljana
Study officials:
References:
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citation: Lunder M, Janic M, Savic V, Janez A, Kanc K, Sabovic M. Very low-dose fluvastatin-valsartan combination decreases parameters of inflammation and oxidative stress in patients with type 1 diabetes mellitus. Diabetes Res Clin Pract. 2017 May;127:181-186. doi: 10.1016/j.diabres.2017.03.019. Epub 2017 Mar 22.
citation: Lunder M, Janic M, Jug B, Sabovic M. The effects of low-dose fluvastatin and valsartan combination on arterial function: a randomized clinical trial. Eur J Intern Med. 2012 Apr;23(3):261-6. doi: 10.1016/j.ejim.2011.11.011. Epub 2011 Dec 12.
citation: Boncelj Svetek M, Erzen B, Kanc K, Sabovic M. Impaired endothelial function and arterial stiffness in patients with type 2 diabetes - The effect of a very low-dose combination of fluvastatin and valsartan. J Diabetes Complications. 2017 Mar;31(3):544-550. doi: 10.1016/j.jdiacomp.2016.12.002. Epub 2016 Dec 16.
citation: Janic M, Lunder M, Cerkovnik P, Prosenc Zmrzljak U, Novakovic S, Sabovic M. Low-Dose Fluvastatin and Valsartan Rejuvenate the Arterial Wall Through Telomerase Activity Increase in Middle-Aged Men. Rejuvenation Res. 2016 Apr;19(2):115-9. doi: 10.1089/rej.2015.1722. Epub 2016 Jan 22.