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.
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.
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.
Parallel
Multidisciplinary Cardio-Renal Care
Other interventionA structured, multidisciplinary intervention comprising guideline-directed assessment and optimisation of cardiovascular and renal treatment, based on latest guideline recommandations from ESC and KDIGO. The intervention include treatment of: * Heart failure * Blood pressure management * Thrombosis prophylaxis * Dyslipidaemia management * Kidney protectective therapies * Treatment of kidney failure complications * Counseling on lifestyle factors, including diet, alcohol consumption, smoking, physical activity, weight management, and sleep apnea.
Long-term outcome: Major Cardiorenal Events
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
Change in E/e' (rest) in participants with HFpEF; between-group difference. Absolute value and change from baseline.
Diastolic function (rest and exercise)
Change in E/e' (rest and exercise) in the overall study population; between-group difference. Absolute value and change from baseline.
Neurohormonal activation
NT-proBNP. Change from baseline to 1-year follow-up. pg/mL
HFpEF classification and prevalence
Prevalence of HFpEF and comparison of diagnostic algorithms. Prevalence and change in classification from baseline to 1-year follow-up.
Albuminuria
Change in UACR from baseline to 1-year follow-up; between-group difference. mg/g
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