Cardiovascular Diseases Clinical Trial
— OPTIMISEOfficial 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
NCT number | NCT06444711 |
Other study ID # | 343919 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2024 |
Est. completion date | April 2045 |
Verified date | June 2024 |
Source | University of Leeds |
Contact | Chris Gale |
Phone | 07779413379 |
c.p.gale[@]leeds.ac.uk | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Not yet recruiting |
Enrollment | 138 |
Est. completion date | April 2045 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Consented participants in the FIND-AF study - Higher predicted FIND-AF risk according to the FIND-AF score Exclusion Criteria: - Unable to give written informed consent for participation in the study - Unable to adhere to the study requirements |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Leeds |
A Language and Environment for Statistical Computing_. R Foundation for Statistical Computing, Vienna, Austria. https://www.R-project.org/.
Dale CE, Takhar R, Carragher R, Katsoulis M, Torabi F, Duffield S, Kent S, Mueller T, Kurdi A, Le Anh TN, McTaggart S, Abbasizanjani H, Hollings S, Scourfield A, Lyons RA, Griffiths R, Lyons J, Davies G, Harris D, Handy A, Mizani MA, Tomlinson C, Thygesen — View Citation
Herrett E, Gallagher AM, Bhaskaran K, Forbes H, Mathur R, van Staa T, Smeeth L. Data Resource Profile: Clinical Practice Research Datalink (CPRD). Int J Epidemiol. 2015 Jun;44(3):827-36. doi: 10.1093/ije/dyv098. Epub 2015 Jun 6. — View Citation
Marx N, Federici M, Schutt K, Muller-Wieland D, Ajjan RA, Antunes MJ, Christodorescu RM, Crawford C, Di Angelantonio E, Eliasson B, Espinola-Klein C, Fauchier L, Halle M, Herrington WG, Kautzky-Willer A, Lambrinou E, Lesiak M, Lettino M, McGuire DK, Mulle — View Citation
Nadarajah R, Wu J, Hogg D, Raveendra K, Nakao YM, Nakao K, Arbel R, Haim M, Zahger D, Parry J, Bates C, Cowan C, Gale CP. Prediction of short-term atrial fibrillation risk using primary care electronic health records. Heart. 2023 Jun 26;109(14):1072-1079. — View Citation
Nakao YM, Gale CP, Miyazaki K, Kobayashi H, Matsuda A, Nadarajah R, Motonishi T. Impact of a national screening programme on obesity and cardiovascular risk factors. Eur J Prev Cardiol. 2023 Mar 1;30(4):331-339. doi: 10.1093/eurjpc/zwac283. — View Citation
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Ortiz A, Wanner C, Gansevoort R; ERA Council. Chronic kidney disease as cardiovascular risk factor in routine clinical practice: a position statement by the Council of the European Renal Association. Eur J Prev Cardiol. 2022 Dec 7;29(17):2211-2215. doi: 1 — View Citation
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Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschi — View Citation
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Zelniker TA, Wiviott SD, Raz I, Im K, Goodrich EL, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Furtado RHM, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Sabatine MS. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes i — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Components of primary endpoint | The proportion of participants who have experienced any of the individual components of primary endpoint which are an initiation or increase in the dose regimen of each of the following:
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 | Time to primary endpoint | The median time to primary endpoint from randomisation reported in days eg the date of initiation or increase in the dose regimen of one of the following:
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 | Number of participants developing a new cardio-renal-metabolic-pulmonary risk factor | Number of patients receiving a diagnosis of new cardio-renal-metabolic-pulmonary risk factor (hypertension, diabetes, chronic kidney disease, obesity, current smoking, COPD) between randomisation and six months. | 6 months | |
Secondary | Time to diagnosis of a new cardio-renal-metabolic-pulmonary risk factor | Time to diagnosis of a new cardio-renal-metabolic-pulmonary risk factor | 6 months | |
Secondary | Number of participants with a new uptake of guideline directed risk factor management | Number of participants with a new uptake of guideline directed risk factor management in those with recorded cardio-renal-metabolic-pulmonary risk factors (hypertension, lipid modification, diabetes, chronic kidney disease, obesity, current smoking, COPD), between randomisation and six months | 6 months | |
Secondary | Change in EuroQol five dimensional descriptive system (EQ-5D-5L) questionnaire score | A comparison of the two arms of the change in EuroQol five dimensional descriptive system (EQ-5D-5L) questionnaire score between randomisation and six months follow-up with a large change indicating a better outcome. Analysis will be carried out as per the EuroQoL guidance and will incorporate both questions and scale participant responses.
The EQ-5D-5L has a maximum index value of 1, representing full health, and a minimum index value of -0.59, which corresponds to the worst health state. The instrument includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having five levels. We will be measuring the change in index value between baseline and 6 months. |
6 months |
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