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Search / Trial NCT05474079

Exercise Training & Statins for Cardiovascular Health

Launched by CARDIFF METROPOLITAN UNIVERSITY · Jul 21, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how exercise training combined with statin medication may help improve heart and blood vessel health in people at risk for cardiovascular disease (CVD). Specifically, researchers want to find out if regular supervised exercise can enhance blood vessel function in individuals who have a 10% or higher risk of developing CVD, and whether this effect is different for those who are taking statins compared to those who are not.

To be eligible for this trial, participants must be sedentary, non-smokers, and between the ages of 50 and 65, with a CVD risk score above 10%. Those taking statins must have been on the medication for at least three months. Participants can expect to engage in supervised exercise sessions designed to improve their cardiovascular health. It's important to note that individuals with certain health conditions or those who are currently smoking are not eligible to participate. This study aims to gather valuable information that could help shape future recommendations for preventing heart disease.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Statin Users:
  • Sedentary
  • Non-smokers
  • 50-65 years old
  • A 10-year CVD-risk score \> 10% (estimated via QRISK3)
  • Weight stable (\<5% weight change over the last 3 months)
  • Prescription of an 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMG-CoA) inhibitor (statin) in stable dose for a minimum of 3 months and maximum of 3 years
  • Non-Statin Users:
  • Sedentary
  • Non-smokers
  • 50-65 years old
  • A 10-year CVD-risk score \> 10% (estimated via QRISK3)
  • Weight stable (\<5% weight change over the last 3 months)
  • Exclusion Criteria (Statin Users and Non-Statin Users):
  • History or signs/symptoms of established cardiovascular, metabolic, renal or musculoskeletal disease
  • Diagnosed with familial hyperlipidaemia and/or diabetes mellitus
  • Stage 2 hypertension (≥160/100 mmHg)
  • Any contraindications to exercise (e.g. unstable angina, severe orthopaedic conditions) and/or advised by GP not to undertake exercise
  • BMI \>40kg/m2
  • Current smoker or within 6 months of cessation
  • Use of any medication other than statins (e.g., fibrates, metformin, thiazolidinediones, orlistat, anti-hypertensives) that could independently alter lipid metabolism and/or vascular function
  • Post-menopausal female and using hormone replacement therapy, or pre-menopausal using oral contraceptives that independently alter lipid metabolism and/or vascular function

About Cardiff Metropolitan University

Cardiff Metropolitan University is a leading academic institution in the UK, renowned for its commitment to innovative research and development in various fields, including health and biomedical sciences. As a clinical trial sponsor, the university leverages its expertise and resources to conduct rigorous and ethical research aimed at advancing medical knowledge and improving patient outcomes. With a focus on collaboration and interdisciplinary approaches, Cardiff Metropolitan University fosters partnerships with healthcare providers, industry stakeholders, and regulatory bodies to ensure the successful design, implementation, and dissemination of clinical trials that address critical health challenges.

Locations

Cardiff, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Chris Pugh

Principal Investigator

Cardiff Metropolitan University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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