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NCT06444711Active, not recruiting

OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals

A Randomised Clinical Trial for OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals and Evaluation of Outcomes

Source: ClinicalTrials.gov · Last updated 17 Sept 2025

Brief summary (registry, in English)

Cardiovascular disease (CVD) causes a quarter of all deaths in the United Kingdom (UK). This is the single biggest area where the National Health Service (NHS) can save lives by detecting and treating risk factors early. Improvements in control of blood pressure, cholesterol, diabetes, kidney disease, as well as weight loss in individuals who are obese, have been shown to reduce the risk of CVD and death. The NHS has guidelines for investigations and treatments for risk factors recommended by the National Institute for Health and Care Excellence (NICE). Though it is known that better control of risk factors will reduce the risk of CVD the investigators do not know whether having extra appointments in primary care with heart specialists can lead to better treatment and better control of risk factors. The OPTIMISE trial (OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals) will compare patients who have consultations at a local General Practitioner (GP) practice by a cardiology professional to optimise the treatment of their risk factors (OPTIMISE) with those patients who receive standard care (Standard care). Standard care is patients being seen by their GP at routine care appointments. Participants in the OPTIMISE arm will be reviewed by the cardiology professional and recommended treatment in line with current NICE guidance. They will be seen at 3 months to review their treatment and potentially adjusted to ensure it meets NICE guidelines. Participants in the standard arm will have data related to their cardiovascular, renal, metabolic and pulmonary risk factors collected through their Electronic Health Record (EHR). At 6 months, all participants will be seen to find out changes to their prescribed medication and the effect of this on their blood pressure, cholesterol, blood sugar level, and body mass index (BMI). All participants will also complete a quality of life questionnaire prior to randomisation study and at 6 months to identify any differences between the arms and time points.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
138 (estimated)
First submitted
23 May 2024
Start date
7 May 2025
Primary completion date
Feb 2026
Lead sponsor
University of Leeds
NCT number
NCT06444711

What you commit to

  • Study type: Interventional
  • Planned participants: 138
  • From 7 May 2025 to the primary completion date, Feb 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Unable to give written informed consent for participation in the study
  • Unable to adhere to the study requirements

Who the study is looking for

  • Consented participants in the FIND-AF study
  • Higher predicted FIND-AF risk according to the FIND-AF score

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Leeds
Coordinator of this site? Confirm its status
LeedsUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.