The condition under investigation is the disease changes that occur in patients with mild kidney disease that cause them to have a high rate of diseases such as heart failure, rhythm disturbance and stroke.
Conditions
Interventions
Product Name: SPIRONOLACTONE
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Spironolactone
CAS Number: 52-01-7
Other descriptive name: Aldosterone antagonist
Concentration unit: mg milligram(
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged over 18 years - Diagnosis of stage 3 CKD (eGFR by 4 variable MDRD of 30-59 ml/min/1.73m2 on 2 occasions, at least 3 months apart) - Well controlled blood pressure (office reading of 6 weeks) treatment with ACE inhibitors or ARBs. 5) Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: - Diabetes mellitus - Clinical evidence of hypovolaemia - Recent (<6 months) acute myocardial infarction or other major adverse cardiovascular event - Established diagnosis of left ventricular dysfunction or heart failure - Active malignant disease with a life expectancy of <5 years - Previous hyperkalaemia (K+ =6.0 mmol/l without precipitating cause) - Serum K+ =5.0 mmol/l at entry - Serum sodium <132 mmol/l at entry - Atrial fibrillation on screening ECG - Use of a thiazide or loop diuretic in the 6 weeks prior to enrolment - Pregnancy - Known alcohol or drug abuse - Active chronic diarrhoeal illness - Recent active gout (within 3 months) - Episode of acute kidney injury within 3 months - Documented Addison’s disease - Current treatment with fludrocortisone or co-trimoxasole - Office blood pressure <115 mmHg systolic or <50 mmHg diastolic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does giving Spironolactone to patients with early stage chronic kidney disease reduce arterial stiffness and left ventricular mass to a greater degree than the standard blood pressure lowering drug treatment, Chlortalidone?;Secondary Objective: To see the effect of using spironolactone on: 1) Frequency of elevated blood potassium concentration. 2) Blood pressure measured using an arm cuff 3) The amount of protein leaking out of the kidneys in to the urine 4) Kidney function measured by blood tests 5) The occurrence of low blood pressure that might make subjects feel faint 6) Occurrence of side effects due to treatment 7) Heart size and pumping function 8) The level of a hormone in the blood that rises when heart function is poor 9) Measures of artery function that occur during the treatment period ;Primary end point(s): a) Change in arterial stiffness measured by carotid-femoral pulse wave velocity b) Change in LV mass measured by cardiac magnetic resonance imaging ;Timepoint(s) of evaluation of this end point: a) At rand and at weeks 4, 24, 40 & 46 by SphygmoCor b) At rand and at week 40 by CMR | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Incidence of hyperkalaemia b) Change in blood pressure c) Change in urinary albumin:creatinine ratio d) Decline in renal function (requiring discontinuation from trial therapy) e) Symptomatic hypotension (requiring discontinuation from trial therapy) f) Incidence of side-effects (requiring discontinuation from trial therapy) g) Changes in left ventricular volumes and systolic function h) Changes in plasma NT-pro-BNP i) Changes in arterial stiffness measures including pulse wave velocity, augmentation index and central blood pressure (measured at 24 weeks) ;Timepoint(s) of evaluation of this end point: a) b) Measured at rand and at weeks 1, 2, 4, 8, 24, 40 & 46. c) d) e) f) g) h) Measured at rand and at weeks 4, 24, 40 & 16 i) | — |
Countries
United Kingdom
Contacts
Public ContactDr Margaret Grant
Birmingham Clinical Trials Unit
Outcome results
None listed