Optimised Cardio-Renal Care for CKD and heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines a multidisciplinary Cardio-Renal Clinic designed to care for patients with both chronic kidney disease and cardiovascular disease, including HFpEF. Participants undergo a structured, guideline-based treatment plan and comprehensive baseline assessments, followed by long-term follow-up to compare outcomes with usual care. Primary questions focus on improvements in heart and kidney function, quality of life, symptoms, and physical ability after one year, with longer-term effects on mortality and major cardiovascular or renal events assessed over five years. The study leverages existing evidence for SGLT2 inhibitors and mineralocorticoid receptor antagonists while addressing gaps in real-world guideline implementation. Eligible participants are adults with CKD and established cardiovascular disease, excluding those with HF with reduced ejection fraction, diabetes, dialysis, kidney transplant, or limited life expectancy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Cardiovascular Research Unit, Odense University Hospital Svendborg
  Svendborg, Denmark Recruiting

Study contacts

• Principal investigator: Søren Auscher, MD, PhD, Associated Professor — Odense University Hospital
• Study coordinator: Eline Panadevo, MD
• Email: eline.panadevo@rsyd.dk
• Phone: +45 63 20 24 02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.