Prospective study of prognostic markers of kidney damage in cardiorenal syndrome

Recruiting

• Conditions: Chronic kidney disease in cardiorenal syndrome; N18; Chronic kidney disease

• Registration Number: DRKS00026098
• Lead Sponsor: niversitätsmedizin Göttingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Adult patients capable of consent
- Age = 18 years
- Outpatients able to consent and cooperate
- Written consent to study participation
- Patients with a cardio-renal risk profile on stable guideline medication for > 3 months (at least 1 of the following applies):
A) Patients for whom SGLT2 inhibitor therapy is planned as part of best clinical practice:
Diabetes mellitus II with nephropathy (group 1)
CKD and HFrEF (echocardiographically confirmed) (Group 2)
CKD without diabetes (Group 3)
CKD and HFpEF (Group 7)

B) independent of further treatment:
Patients with arterial hypertension without HFpEF (group 4)
Patients with arterial hypertension with HFpEF (group 5)

control group
Inclusion Criteria:
• Outpatients and inpatients at the Clinic for Nephrology and Rheumatology
• Age = 18 years
• Written consent to study participation
• No evidence of renal or cardiac disease on physical examination

Exclusion Criteria

- Patients who have had a kidney transplant (NTX) or require dialysis
- Chronic renal insufficiency CKD stage> G4 (<15 ml / min according to the CKD EPI formula)
- ADPKD
- Current acute kidney damage
- Postrenal obstruction
- (Proven) pulmonary hypertension in the context of causes other than heart failure (class 2)
- pregnancy or breastfeeding
- Circumstances that interfere with the implementation or interpretation of the measured variables, such as severely restrictive respiratory diseases, strongly fluctuating blood pressure values ??and others
- Presence of type I diabetes mellitus
- Active tumor disease
- Inflammatory or autoimmune disease that affects kidney function
- Circumstances that could interfere with the results of the Doppler sonographic evaluation (e.g. significantly restrictive respiratory diseases, strongly fluctuating blood pressure values, BMI> 40 kg / m2, etc.) Circumstances that could interfere with participation in the study (e.g. known non-adherence)

Control group
Exclusion criteria
• Heart failure (HFpEF, HFmrEF, HFrEF)
• diabetes mellitus
• Refractory hypertension
• Albuminuria> 30mg / g creatinine
• eGFR <60 ml / min according to CKD-EPI
• pathological urine sediment (e.g. significant hematuria, leukocyturia)
• Active tumor disease
• Active or uncontrolled inflammatory or autoimmune disease
• CRP> 20 mg / l
• Circumstances that could interfere with the results of the Doppler sonographic evaluation (e.g. clearly restrictive respiratory diseases, strongly fluctuating blood pressure values, BMI> 40 kg / m2 etc.)
• Circumstances that could interfere with participation in the study (e.g. known non-adherence)
• Pregnancy or breastfeeding

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of renal venous congestion in the different groups of patients at cardiorenal risk and the control group.<br><br>Evaluation of the development of renal-venous congestion as well as laboratory biomarkers in patients who receive therapy with an SGLT2 inhibitor due to their underlying disease.

Secondary Outcome Measures

Name	Time	Method
Correlation of renal venous congestion and laboratory biomarkers with the renal outcome of the patients.