SodiUm Burden lowered by Lifestyle Intervention: Self-Management and E-health technology

Completed

• Conditions: Chronic kidney disease; renal disease; 10029149

• Registration Number: NL-OMON40912
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. Be 18 years or older.
2. Have chronic kidney disease (CKD stage 1-3, CKD 4 if eGFR is not lower than 25 mL/min/1.73m2, or be a renal transplant recipient.)
3. Have a urinary sodium excretion during at least the last 2 subsequent visits of more than 130 mmol per day, or one last urinary sodium excretion of more than 150 mmol per day.
4. Have a systolic blood pressure higher than 135 mmHg, diastolic blood pressure higher than 85 mmHg or a well-controlled blood pressure by treatment with antihypertensives including RAAS-blockade (ACE-inhibitor or ARB).
5. Sufficient command of the Dutch language.
6. Access and ability to use the internet.
7. Written informed consent.

Exclusion Criteria

- eGFR < 25 ml/min/1.73m2 or an anticipated need for predialysis work-up within the time frame of the study.
- Unstable disease: defined as rapid, persistent, progressive renal function loss (e.g. > 6 mL/min/1.73m2 per year), not from acute, intermittent origin.
- Blood pressure > 170 mmHg systolic or > 100 mmHg diastolic during medical treatment
- Blood pressure < 95 mmHg systolic not responding to withdrawal of antihypertensives.
- Cardiovascular event (myocardial infarction, cerebrovascular accident) < 6 months ago.
- Renal transplantation <1 year ago.
- Medical conditions that are likely to interfere with completion of the study (such as progressive malignancy or other debilitating illness) at the discretion of the nephrologist.
- Every patient who has participated in the ESMO study (regardless whether intervention or control) cannot participate in the current study.
- Current participation in any clinical trial that might interfere with SUBLIME trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome: sodium intake, assessed from 24h sodium excretion, </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes: blood pressure, proteinuria, psychological well-being and<br /><br>costs-efficiency, efficacy.</p><br>