Chronic Kidney Disease
Conditions
Interventions
Patients and healthy subjects will be randomized to a 8-week period with RAAS inhibitor treatment (Lisinopril 10 mg once daily) followed by a 8-week period without RAAS inhibitor treatment (or vice ve
Sponsors
AUMC - AMC
Eligibility
Inclusion criteria
Inclusion criteria: Patients: • Adult patients (= 18 years) with CKD 3b or 4 (45 – 15 ml/min/1.73 m2). • Hypertension (defined as office blood pressure > 140/90 mmHg and using RAAS inhibitor treatment). Healthy subjects: • Healthy adults (= 18 years), as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination (PE) and laboratory tests carried out in the screening visit (V0). • Using no medication (excluding contraceptives).
Exclusion criteria
Exclusion criteria: Patients: • Hyperkalemia (serum potassium > 5.5 mmol/l). • Medical reasons to continue dual RAAS-blockade, mineralocorticoid receptor blockers, potassium-sparing diuretics, or oral potassium binders. • Patients with previous history of ventricular cardiac arrhythmia. • Patients with diabetes mellitus. • Patients with a life expectancy 5.5 mmol/l). • Women who are pregnant, breastfeeding or consider pregnancy in the coming 6 months. • An office blood pressure = 140/90 mmHg. • A body mass index = 30 kg/m2. • A major illness in the past 3 months or any significant chronic medical illness that the investigator would deem unfavourable for enrolment, including diabetes mellitus. • A history of any type of malignancy within the past 5 years with the exception of successfully treated basal cell carcinoma of the skin. • A history of any renal disease. • A history of any blood clotting disorders. • A history of any auto-immune disease. • A history of cardiovascular disease (in the past 6 months) defined as documented coronary artery disease including myocardial infarction (MI), (un-)stable angina pectoris or acute coronary syndrome (ACS), percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass grafting (CABG), cerebrovascular disease, including ischaemic and haemorrhagic stroke or a subarachnoid bleeding (SAB), or peripheral artery disease, including aortic aneurysmata (AA). • A history of ventricular cardiac arrhythmia. • Any significant sign or symptom of hypotension.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will include Red Blood Cell (RBC) potassium (in mmol/L), renal potassium excretion, serum sodium, renal sodium excretion, total body water, and systolic blood pressure, as well as changes in serum bicarbonate, insulin, and plasma aldosterone. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint will be serum potassium (in mmol/L). | — |
Contacts
Public ContactRosa Wouda
AUMC
Outcome results
None listed