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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03393377
Other study ID # AGE-ZT
Secondary ID
Status Completed
Phase N/A
First received December 29, 2017
Last updated January 5, 2018
Start date September 2014
Est. completion date June 2017

Study information

Verified date January 2018
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study was designed to test whether short-term treatment with a very low-dose combination of fluvastatin and valsartan could induce improvement of endothelial function, arterial stiffness, vascular inflammation, oxidative stress and expression of protective genes in subjects with moderate cardiovascular risk.


Description:

The largest population that suffers from cardiovascular events are subjects at moderate cardiovascular risk. However, no effective and safe preventive treatment is available for this population. This study aimed to investigate whether their arterial wall phenotype could be turned to a preventive direction by low-dose fluvastatin/valsartan combination (low-flu/val).

Twenty males at moderate cardiovascular risk (as classified by SCORE) were blindly randomised into the intervention group (n=10, low-flu/val: 10 mg/20mg) or control group (n=10, placebo). At inclusion and after 30 days of treatment, brachial flow-mediated dilatation (FMD), beta stiffness coefficient, carotid pulse wave velocity (c-PWV), carotid-femoral PWV, reactive hyperaemia index, high-sensitivity C-reactive protein (hs-CRP), interleukin 6, vascular cell adhesion molecule 1, total antioxidant status and expression of several protective genes (SIRT1, mTOR, NF-κB1, NFE2L2, PRKAA1) were followed.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2017
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 55 Years
Eligibility Inclusion Criteria:

- moderate cardiovascular risk according to Systematic Coronary Risk Estimation (SCORE) risk charts of the European Society of Cardiology

- males

- aged between 40 and 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
fluvastatin 10 mg and valsartan 20 mg

placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Medical Centre Ljubljana

References & Publications (10)

Boncelj Svetek M, Eržen B, Kanc K, Šabovic 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. — View Citation

Janic M, Lunder M, Prezelj M, Šabovic M. A combination of low-dose fluvastatin and valsartan decreases inflammation and oxidative stress in apparently healthy middle-aged males. J Cardiopulm Rehabil Prev. 2014 May-Jun;34(3):208-12. doi: 10.1097/HCR.0000000000000027. — View 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. — View Citation

Matsuzawa Y, Kwon TG, Lennon RJ, Lerman LO, Lerman A. Prognostic Value of Flow-Mediated Vasodilation in Brachial Artery and Fingertip Artery for Cardiovascular Events: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2015 Nov 13;4(11). pii: e002270. doi: 10.1161/JAHA.115.002270. Review. — View Citation

Paneni F, Diaz Cañestro C, Libby P, Lüscher TF, Camici GG. The Aging Cardiovascular System: Understanding It at the Cellular and Clinical Levels. J Am Coll Cardiol. 2017 Apr 18;69(15):1952-1967. doi: 10.1016/j.jacc.2017.01.064. Review. — View Citation

Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corrà U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FD, Løchen ML, Löllgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WM; Authors/Task Force Members. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-81. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23. — View Citation

Robinson JG, Gidding SS. Curing atherosclerosis should be the next major cardiovascular prevention goal. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt A):2779-85. doi: 10.1016/j.jacc.2014.04.009. Epub 2014 May 7. — View Citation

Sosnowska B, Mazidi M, Penson P, Gluba-Brzózka A, Rysz J, Banach M. The sirtuin family members SIRT1, SIRT3 and SIRT6: Their role in vascular biology and atherogenesis. Atherosclerosis. 2017 Oct;265:275-282. doi: 10.1016/j.atherosclerosis.2017.08.027. Epub 2017 Aug 26. Review. — View Citation

Vlachopoulos C, Aznaouridis K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Mar 30;55(13):1318-27. doi: 10.1016/j.jacc.2009.10.061. Review. — View Citation

Yusuf S, Bosch J, Dagenais G, Zhu J, Xavier D, Liu L, Pais P, López-Jaramillo P, Leiter LA, Dans A, Avezum A, Piegas LS, Parkhomenko A, Keltai K, Keltai M, Sliwa K, Peters RJ, Held C, Chazova I, Yusoff K, Lewis BS, Jansky P, Khunti K, Toff WD, Reid CM, Varigos J, Sanchez-Vallejo G, McKelvie R, Pogue J, Jung H, Gao P, Diaz R, Lonn E; HOPE-3 Investigators. Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease. N Engl J Med. 2016 May 26;374(21):2021-31. doi: 10.1056/NEJMoa1600176. Epub 2016 Apr 2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary brachial flow-mediated dilatation (FMD) FMD measured by ultrasound on right brachial artery (as result of reactive hyperaemia) 30 days
Primary reactive hyperaemia index (RHI) RHI measured by Endopat device 30 days
Primary beta stiffness coefficient assessed by ultrasound employing e-Tracking on right common carotid artery 30 days
Primary carotid pulse wave velocity (c-PWV) assessed by ultrasound employing e-Tracking on right common carotid artery 30 days
Primary carotid-femoral PWV (cf-PWV) cf-PWV measured by Sphygmocor device 30 days
Primary high-sensitivity C-reactive protein (hs-CRP) inflammatory marker 30 days
Primary interleukin 6 (IL-6) inflammatory marker 30 days
Primary vascular cell adhesion molecule 1 (VCAM1) inflammatory marker 30 days
Primary total antioxidant status (TAS) marker of oxidative stress 30 days
Primary gene SIRT1 Hs01009006_m1 30 days
Primary gene mTOR Hs00234522_m1 30 days
Primary gene NF-kB1 Hs00765730_m1 30 days
Primary gene Nrf2/NFE2L2 Hs00975961_g1 30 days
Primary gene AMPK/PRKAA1 Hs01562315_m1 30 days
Secondary brachial flow-mediated dilatation (FMD) FMD measured by ultrasound on right brachial artery (as result of reactive hyperaemia) 10 weeks after treatment completion
Secondary reactive hyperaemia index (RHI) RHI measured by Endopat device 10 weeks after treatment completion
Secondary beta stiffness coefficient assessed by ultrasound employing e-Tracking on right common carotid artery 10 weeks after treatment completion
Secondary carotid pulse wave velocity (c-PWV) assessed by ultrasound employing e-Tracking on right common carotid artery 10 weeks after treatment completion
Secondary carotid-femoral PWV (cf-PWV) cf-PWV measured by Sphygmocor device 10 weeks after treatment completion
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