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

NCT06444711 | Active Not Recruiting DMC

• 1 other identifier: 343919
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases; Renal Disease; Metabolic Disease; Pulmonary Disease

Keywords

Cardiology; Atrial Fibrillation; Renal disease; Metabolic disease; Pulmonary disease

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with any of the following therapeutic intervention to optimise cardio-renal-metabolic-pulmonary risk factor management

  The proportion of patients with any of the following therapeutic intervention to optimise cardio-renal-metabolic-pulmonary risk factor management including initiation or increase in dose regimen of: * Angiotensin converting enzyme inhibitor / angiotensin 2 receptor blocker * Calcium channel blocker / thiazide-like diuretic / spironolactone / alpha blocker / beta blocker * SGLT2 inhibitor * Glucagon-like peptide (GLP) -1 receptor agonist * Metformin / Dipeptidyl peptidase 4 (DPP4) inhibitor / pioglitazone / sulphonylurea / insulin * Statin / ezetimibe / icosapent ethyl / bempedoic acid / PCSK9 inhibitor * Orlistat * Nicotine replacement therapy / bupropion * Inhaler therapy

  6 months

Secondary Outcomes (6)

• Components of primary endpoint

  6 months

• Time to primary endpoint

  6 months

• Number of participants developing a new cardio-renal-metabolic-pulmonary risk factor

  6 months

• Time to diagnosis of a new cardio-renal-metabolic-pulmonary risk factor

  6 months

• Number of participants with a new uptake of guideline directed risk factor management

  6 months

Study Arms (2)

Standard care

NO INTERVENTION

The participant will complete a questionnaire (EQ-5D-5L) at both baseline and six months. Their baseline information will be collected from their electronic health records. They will be advised to see their GP as part of their routine care. At six months they will attend a visit where their clinical observations will be recorded.

Optimisation arm

ACTIVE COMPARATOR

Participants in the intervention arm will attend a baseline visit and two further research appointments at three months and six months from time of randomisation, For baseline assessment, the research cardiology doctor will review the participant's GP records with relation to previous cardiovascular disease, hypertension, dyslipidaemia, chronic kidney disease, diabetes, BMI, COPD and smoking history. They will conduct observations and blood tests that are recommended in NICE guidance if the results are not already available. They will carry out an ambulatory lung test (to screen for risk of pulmonary diseases). They will recommend changes to treatment if the treatment the patient is currently on does not adhere to guidelines. The research team will provide a letter and verbal communication with the participant's GP of the recommendations. For the second visit at three months after randomisation, the research team doctor will conduct the same review as undertaken at the first visit.

Other: NICE guidance

Interventions

NICE guidance OTHER

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

Optimisation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

Related Publications (13)

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  PMID: 30424892 BACKGROUND

• Yumuk V, Tsigos C, Fried M, Schindler K, Busetto L, Micic D, Toplak H; Obesity Management Task Force of the European Association for the Study of Obesity. European Guidelines for Obesity Management in Adults. Obes Facts. 2015;8(6):402-24. doi: 10.1159/000442721. Epub 2015 Dec 5.

  PMID: 26641646 BACKGROUND

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• A Language and Environment for Statistical Computing_. R Foundation for Statistical Computing, Vienna, Austria. https://www.R-project.org/.

  BACKGROUND

• Nadarajah R, Wahab A, Joseph T, Reynolds C, Bennett S, Haris M, Smith AB, Hayward C, Wu J, Gale CP. Protocol for the OPTIMSE-1 randomised clinical trial to test specialist-led identification and management of cardio-renal-metabolic-pulmonary disease in machine learning algorithm-detected high-risk community-dwelling individuals. BMJ Open. 2025 Aug 6;15(8):e101088. doi: 10.1136/bmjopen-2025-101088.

  PMID: 40774703 DERIVED

Related Links

• British Heart Foundation. UK Fact sheet. 2024
• National Institute for Health and Care Excellence. Hypertension in adults: diagnosis and management. 21 November 2023

MeSH Terms

Conditions

Cardiovascular Diseases; Kidney Diseases; Metabolic Diseases; Lung Diseases; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nutritional and Metabolic Diseases; Respiratory Tract Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris P. Gale

  University of Leeds

  PRINCIPAL INVESTIGATOR

• Ramesh Nadarajah

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An endpoint adjudication committee, blinded to allocation, will review observations, laboratory measures and GP medical records data for the participant to establish adherence of care to guidelines.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiovascular Medicine

Model Details: Multicentre pragmatic prospective randomised open-label blinded-endpoint strategy trial (PROBE).

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 6, 2024
• Study Start: May 7, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): April 1, 2045
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)