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Completed

NCT Number: NCT03393377

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

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.

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Key information

Age range

40 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluvastatin 10 mg and valsartan 20 mg

Drug

Other names: low-flu/val

Placebo

Drug

Primary outcomes

  1. brachial flow-mediated dilatation (FMD)

    Time frame: 30 days

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

  2. reactive hyperaemia index (RHI)

    Time frame: 30 days

    RHI measured by Endopat device

  3. beta stiffness coefficient

    Time frame: 30 days

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

  4. carotid pulse wave velocity (c-PWV)

    Time frame: 30 days

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

  5. carotid-femoral PWV (cf-PWV)

    Time frame: 30 days

    cf-PWV measured by Sphygmocor device

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

    Time frame: 30 days

    inflammatory marker

  7. interleukin 6 (IL-6)

    Time frame: 30 days

    inflammatory marker

  8. vascular cell adhesion molecule 1 (VCAM1)

    Time frame: 30 days

    inflammatory marker

  9. total antioxidant status (TAS)

    Time frame: 30 days

    marker of oxidative stress

  10. gene SIRT1

    Time frame: 30 days

    Hs01009006_m1

  11. gene mTOR

    Time frame: 30 days

    Hs00234522_m1

  12. gene NF-kB1

    Time frame: 30 days

    Hs00765730_m1

  13. gene Nrf2/NFE2L2

    Time frame: 30 days

    Hs00975961_g1

  14. gene AMPK/PRKAA1

    Time frame: 30 days

    Hs01562315_m1

Secondary outcomes

  1. brachial flow-mediated dilatation (FMD)

    Time frame: 10 weeks after treatment completion

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

  2. reactive hyperaemia index (RHI)

    Time frame: 10 weeks after treatment completion

    RHI measured by Endopat device

  3. beta stiffness coefficient

    Time frame: 10 weeks after treatment completion

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

  4. carotid pulse wave velocity (c-PWV)

    Time frame: 10 weeks after treatment completion

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

  5. carotid-femoral PWV (cf-PWV)

    Time frame: 10 weeks after treatment completion

    cf-PWV measured by Sphygmocor device

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Acronym: AGE-ZT

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jan 8, 2018
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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