Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination (AGE-ZT)

January 5, 2018 updated by: Martina Turk Veselič, University Medical Centre Ljubljana

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: intervention group
received fluvastatin 10 mg and valsartan 20 mg (low-flu/val) for 30 days
Drug: fluvastatin 10 mg and valsartan 20 mg
Other Names:
  • low-flu/val
PLACEBO_COMPARATOR: control group
received placebo for 30 days
Drug: placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
10 weeks after treatment completion
reactive hyperaemia index (RHI)
Time Frame: 10 weeks after treatment completion
RHI measured by Endopat device
10 weeks after treatment completion
beta stiffness coefficient
Time Frame: 10 weeks after treatment completion
assessed by ultrasound employing e-Tracking on right common carotid artery
10 weeks after treatment completion
carotid pulse wave velocity (c-PWV)
Time Frame: 10 weeks after treatment completion
assessed by ultrasound employing e-Tracking on right common carotid artery
10 weeks after treatment completion
carotid-femoral PWV (cf-PWV)
Time Frame: 10 weeks after treatment completion
cf-PWV measured by Sphygmocor device
10 weeks after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2014

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

December 29, 2017

First Submitted That Met QC Criteria

January 5, 2018

First Posted (ACTUAL)

January 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGE-ZT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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