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

NCT07835828 | Not Yet Recruiting

• 1 other identifier: S-20260031
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease; Heart Failure With Preserved Ejection Fraction (HFPEF); Cardiovascular Diseases

Keywords

Cardiorenal Syndrome; Chronic Kidney Disease; Heart Failure With Preserved Ejection Fraction; Diastolic Dysfunction; Multidisciplinary Care; Guideline-Directed Medical Therapy; Treatment Optimisation

Outcome Measures

Primary Outcomes (2)

• 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.

  From baseline to 5 years of follow-up.

• Short-term outcome: Diastolic function

  Change in E/e' (rest) in participants with HFpEF; between-group difference. Absolute value and change from baseline.

  From baseline to 1-year follow-up

Secondary Outcomes (19)

• 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

Study Arms (2)

Multidisciplinary Cardio-Renal Care

ACTIVE COMPARATOR

Compromising a multidisciplinary, structured, and specialised optimisation of cardiovascular and renal therapy, including lifestyle interventions, according to contemporary guidelines.

Other: Multidisciplinary Cardio-Renal Care

The Standard Care Group

NO INTERVENTION

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.

Interventions

Multidisciplinary Cardio-Renal Care OTHER

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.

Multidisciplinary Cardio-Renal Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Cardiovascular Research Unit, Odense University Hospital Svendborg

Svendborg, 5700, Denmark

Location

Related Publications (3)

• Solomon SD, McMurray JJV, Claggett B, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Jhund PS, Belohlavek J, Chiang CE, Borleffs CJW, Comin-Colet J, Dobreanu D, Drozdz J, Fang JC, Alcocer-Gamba MA, Al Habeeb W, Han Y, Cabrera Honorio JW, Janssens SP, Katova T, Kitakaze M, Merkely B, O'Meara E, Saraiva JFK, Tereshchenko SN, Thierer J, Vaduganathan M, Vardeny O, Verma S, Pham VN, Wilderang U, Zaozerska N, Bachus E, Lindholm D, Petersson M, Langkilde AM; DELIVER Trial Committees and Investigators. Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2022 Sep 22;387(12):1089-1098. doi: 10.1056/NEJMoa2206286. Epub 2022 Aug 27.

  PMID: 36027570 BACKGROUND

• Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.

  PMID: 32970396 BACKGROUND

• Panadevo E, Thye-Ronn P, Overgaard KS, Egstrup K, Lambrechtsen J, Auscher S. The prevalence and treatment of chronic kidney disease in a cardiology outpatient clinic. Dan Med J. 2026 Apr 21;73(5):A08250635. doi: 10.61409/A08250635.

  PMID: 42095318 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases; Cardio-Renal Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Failure; Heart Diseases

Study Officials

• Søren Auscher, MD, PhD, Associated Professor

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eline Panadevo, MD

CONTACT

+45 63 20 24 02; eline.panadevo@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2038
• Study Completion (Estimated): October 1, 2038
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 12 months after publication of the relevant study results and ending 5 years thereafter.
• Access Criteria: Access may be granted to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed and approved by the OPTICARE study team and, where required, the relevant institutional, ethical, and data-protection authorities. Approved researchers will receive access only to the de-identified data and supporting documents necessary for the approved analyses. Access will be subject to a signed data-sharing agreement and provided through a secure, approved data-transfer or analysis environment. Requests should be directed to the principal investigator.

Locations

DK (1)