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ACTIVE NOT RECRUITING
NCT06444711
NA

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

Sponsor: University of Leeds

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2025-05-07

Completion Date

2045-04

Last Updated

2025-09-17

Healthy Volunteers

No

Interventions

OTHER

NICE guidance

Patients will be assessed to determine whether their current treatment is in line with NICE guidelines. Changes will be made to their treatment plan in order for them to comply with NICE guidelines with the aim of reducing the number of serious adverse events in the group. They will be followed up until 6 months to identify improvements in their conditions

Locations (1)

University of Leeds

Leeds, West Yorkshire, United Kingdom