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AtherosclerosisAGE-ZTNCT03393377

Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination

A study testing fluvastatin 10 mg and valsartan 20 mg in people with Atherosclerosis, run by University Medical Centre Ljubljana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Atherosclerosis
What is being tested?
fluvastatin 10 mg and valsartan 20 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
No sites listed yet
Study dates
Sep 2014to Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

About this study

Official title: Preventive Arterial Wall Phenotype in Subjects at Moderate Cardiovascular Risk Induced by Very Low-dose Fluvastatin/Valsartan Combination: a Pilot Study

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.

Read the detailed 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.

Conditions
Atherosclerosis
Being tested
fluvastatin 10 mg and valsartan 20 mg, placebo
Keywords
arterial stiffness, endothelial dysfunction, fluvastatin, valsartan, inflammatory markers, oxidative stress, SIRT1
Medical subject headings
Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fluvastatin 10 mg and valsartan 20 mgDrug

    Also called low-flu/val

  • placeboDrug

Study groups in NCT03393377
Study groupRoleWhat they receive
intervention groupExperimentalreceived fluvastatin 10 mg and valsartan 20 mg (low-flu/val) for 30 days
Receives: Drug: fluvastatin 10 mg and valsartan 20 mg
control groupPlacebo comparatorreceived placebo for 30 days
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. brachial flow-mediated dilatation (FMD)

    FMD measured by ultrasound on right brachial artery (as result of reactive hyperaemia)

    Measured: 30 days

  2. reactive hyperaemia index (RHI)

    RHI measured by Endopat device

    Measured: 30 days

  3. beta stiffness coefficient

    assessed by ultrasound employing e-Tracking on right common carotid artery

    Measured: 30 days

  4. carotid pulse wave velocity (c-PWV)

    assessed by ultrasound employing e-Tracking on right common carotid artery

    Measured: 30 days

  5. carotid-femoral PWV (cf-PWV)

    cf-PWV measured by Sphygmocor device

    Measured: 30 days

  6. high-sensitivity C-reactive protein (hs-CRP)

    inflammatory marker

    Measured: 30 days

  7. interleukin 6 (IL-6)

    inflammatory marker

    Measured: 30 days

  8. vascular cell adhesion molecule 1 (VCAM1)

    inflammatory marker

    Measured: 30 days

  9. total antioxidant status (TAS)

    marker of oxidative stress

    Measured: 30 days

  10. gene SIRT1

    Hs01009006_m1

    Measured: 30 days

  11. gene mTOR

    Hs00234522_m1

    Measured: 30 days

  12. gene NF-kB1

    Hs00765730_m1

    Measured: 30 days

  13. gene Nrf2/NFE2L2

    Hs00975961_g1

    Measured: 30 days

  14. gene AMPK/PRKAA1

    Hs01562315_m1

    Measured: 30 days

Secondary outcomes (5)

  1. brachial flow-mediated dilatation (FMD)

    FMD measured by ultrasound on right brachial artery (as result of reactive hyperaemia)

    Measured: 10 weeks after treatment completion

  2. reactive hyperaemia index (RHI)

    RHI measured by Endopat device

    Measured: 10 weeks after treatment completion

  3. beta stiffness coefficient

    assessed by ultrasound employing e-Tracking on right common carotid artery

    Measured: 10 weeks after treatment completion

  4. carotid pulse wave velocity (c-PWV)

    assessed by ultrasound employing e-Tracking on right common carotid artery

    Measured: 10 weeks after treatment completion

  5. carotid-femoral PWV (cf-PWV)

    cf-PWV measured by Sphygmocor device

    Measured: 10 weeks after treatment completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2018
  2. Study startSep 2014
  3. Primary completionJun 2015
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03393377
Sponsor's protocol ID
AGE-ZT
Acronym
AGE-ZT
Status last verified
Jan 2018
First submitted
29 Dec 2017
Last updated
8 Jan 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen 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 WMM, Binno S; ESC Scientific Document Group. 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):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23. No abstract available.

    PubMed 27222591

  • 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):e002270. doi: 10.1161/JAHA.115.002270.

    PubMed 26567372

  • 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.

    PubMed 20338492

  • Paneni F, Diaz Canestro C, Libby P, Luscher 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.

    PubMed 28408026

  • 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.

    PubMed 22385885

  • 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.

    PubMed 28012835

  • Janic M, Lunder M, Prezelj M, Sabovic 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.

    PubMed 24263076

  • Sosnowska B, Mazidi M, Penson P, Gluba-Brzozka 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.

    PubMed 28870631

  • Yusuf S, Bosch J, Dagenais G, Zhu J, Xavier D, Liu L, Pais P, Lopez-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.

    PubMed 27040132

  • 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.

    PubMed 24814489

Questions about this trial

What is this clinical trial studying?

A study testing fluvastatin 10 mg and valsartan 20 mg in people with Atherosclerosis, run by University Medical Centre Ljubljana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

brachial flow-mediated dilatation (FMD) (time frame: 30 days). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03393377, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.

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