Optimised Multidisciplinary Cardiovascular and Renal Protection in Patients With Chronic Kidney Disease and Cardiovascular Disease: Effects on Diastolic Function, Cardiovascular and Renal Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Long-term outcome: Major Cardiorenal Events
研究概览
简要总结
The goal of this clinical trial is to investigate whether care in a specialised Cardio-Renal Clinic can improve the health of people living with both cardiovascular disease and chronic kidney disease. The clinic brings together expertise in heart and kidney disease and provides structured treatment based on current clinical guidelines.
The main research questions are:
- After one year, does care in the Cardio-Renal Clinic improve measures of heart and kidney function, quality of life, symptoms, and physical ability compared with usual care?
- After five years, does care in the Cardio-Renal Clinic reduce the risk of death, hospitalisation for heart failure, heart attack, stroke, worsening kidney function, or kidney failure compared with usual care? At the beginning of the study, all participants will undergo a detailed assessment of their heart and kidney health. This will include blood and urine tests, an ultrasound examination of the heart, questionnaires, and tests of physical ability.
Participants will then be randomly assigned to either optimised care in the Cardio-Renal Clinic or usual care.
Participants assigned to the Cardio-Renal Clinic will have their treatment reviewed and adjusted by a multidisciplinary team. The clinic may recommend or prescribe approved medications that are already used in routine care for heart and kidney disease. No experimental medications will be used.
Participants assigned to usual care will continue to receive care from their general practitioner and any hospital departments involved in their treatment.
详细描述
Background Cardiovascular disease (CVD) and chronic kidney disease (CKD) frequently coexist and together constitute a major global health burden associated with substantially increased morbidity, mortality, and healthcare utilisation. Importantly, the coexistence of CVD and CKD predisposes patients to heart failure with preserved ejection fraction (HFpEF), a complex clinical syndrome characterised by a high symptom burden, impaired quality of life, and a poor prognosis. HFpEF accounts for approximately half of all heart failure cases and may further aggravate the progressive interaction between cardiovascular and renal dysfunction.
Over the past decade, major therapeutic advances have improved outcomes in patients with CVD, CKD, and HFpEF. Large randomised trials, including DELIVER and EMPEROR-Preserved, have demonstrated that sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors) improve clinical outcomes in patients with HFpEF. Renin-angiotensin system inhibitors and SGLT2 inhibitors also reduce adverse outcomes in patients with CKD. Furthermore, emerging evidence supports the use of non-steroidal mineralocorticoid receptor antagonists in patients with HFpEF or CKD.
Despite this strong evidence base, the implementation of guideline-directed treatment remains suboptimal. In a pilot study conducted at our centre, only one-third of patients with coexisting CVD and CKD received fully optimised CKD treatment, consistent with findings from similar studies. Consequently, the principal challenge is no longer solely the development of effective therapies, but also the systematic implementation of existing evidence-based treatments in patients with complex multimorbidity.
Current care models are predominantly fragmentated, with cardiology, nephrology, and primary care operating independently. This fragmentation leads to suboptimal coordination, delayed treatment optimisation, and inconsistent application of guidelines.
The OPTICARE Trial addresses this gap by evaluating a structured, multidisciplinary cardiorenal care model designed to optimise treatment in accordance with current clinical guidelines. We hypothesise that this model will significantly improve cardiovascular and renal outcomes compared with standard care and has the potential to transform clinical pathways and future guideline recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Capable of giving written informed consent
- •Established chronic kidney disease, and at least two measurements of: 1) eGFR <45 and >15 mL/min/1.73 m², and/or 2) UACR >200 mg/g, or 3) eGFR <60 mL/min/1.73 m² and UACR >30 mg/g.
- •Established cardiovascular disease, including prior acute coronary syndrome, chronic coronary syndrome, objective evidence of myocardial ischaemia, non-coronary atherosclerotic cardiovascular diase (stroke or peripheral arterial disease), heart failure with preserved ejection fraction, atrial fibrillation and/or flutter, clinically significant valvular disease, or hypertension treated with three or more antihypertensive drugs.
排除标准
- •Established heart failure with reduced ejection fraction.
- •Diabetes type I or II
- •Patients receiving chronic dialysis or having of kidney transplant.
- •Expected life expectancy <5 years.
- •Inability to understand the study procedures, comply with study requirements, or presence of any condition that, in the opinion of the research staff, may interfere with the patient's ability to participate in or complete the study.
- •Participation in another clinical trial with an investigational product or device that could interfere with the primary and/or secondary endpoints of this study.
研究组 & 干预措施
Multidisciplinary Cardio-Renal Care
Compromising a multidisciplinary, structured, and specialised optimisation of cardiovascular and renal therapy, including lifestyle interventions, according to contemporary guidelines.
干预措施: Multidisciplinary Cardio-Renal Care (Other)
The Standard Care Group
Participants will continue their current medical treatment without intervention from the study team. They will be encouraged to continue taking their prescribed medications and attend scheduled appointments with their general practitioner and relevant outpatient clinics.
结局指标
主要结局
Long-term outcome: Major Cardiorenal Events
时间窗: From baseline to 5 years of follow-up.
A composite endpoint of time to first occurrence of any of the following: * Cardiovascular and renal mortality * Worsening heart failure (heart failure hospitalisation or an urgent heart failure visit) * AMI * Stroke * End-stage kidney disease (kidney transplantation, maintenance dialysis for ≥28 days, or eGFR \<15 mL/min/1.73 m² confirmed by a second measurement ≥28 days later) * A sustained decline in eGFR of ≥50%, confirmed by a second serum creatinine measurements after ≥28 days Measured in days.
Short-term outcome: Diastolic function
时间窗: From baseline to 1-year follow-up
Change in E/e' (rest) in participants with HFpEF; between-group difference. Absolute value and change from baseline.
次要结局
- Diastolic function (rest and exercise)(From baseline to 1-year follow-up)
- Neurohormonal activation(From baseline to 1-year follow-up)
- HFpEF classification and prevalence(From baseline to 1-year follow-up.)
- Albuminuria(From baseline to 1-year follow-up)
- eGFR slope (creatinine based)(From baseline to 1-year follow-up)
- Cystatin C(Evaluated at the baseline and 1-year follow-up visit)
- Symptom burden (HF-related)(From baseline to 1-year follow-up.)
- Symptom burden (CKD-related)(From baseline to 1-year follow-up)
- Physical performance(From baseline to 1-year follow-up)
- Disease-specific health status(From baseline to 1-year follow-up)
- Health-related quality of life(From baseline to 1-year follow-up)
- Cardiovascular risk(From baseline to 1-year follow-up.)
- Renal risk(From baseline to 1-year follow-up.)
- Long-term cardiovascular outcomes (five years)(From baseline to 5 years of follow-up.)
- Long-term kidney outcomes (five years)(From baseline to 5 years of follow-up.)
- Composite long-term cardiorenal outcome (ten years)(From baseline to 10 years of follow-up.)
- Long-term cardiovascular outcomes (ten years)(From baseline to 10 years of follow-up.)
- Long-term kidney outcomes (ten years)(From baseline to 10 years of follow-up.)