Optimised Cardiovascular and Renal Protection in Patients With Chronic Kidney Disease and Cardiovascular Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Multidisciplinary Cardio-Renal Care: A 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Long-term outcome: Major Cardiorenal Events — 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 — 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.

Trial sites (1)

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