Hypertension, Microalbuminuria, Type 2 Diabetes Mellitus
Conditions
Keywords
antihypertensive therapy, amiloride, add-on, resistant hypertension, blood pressure control, type 2 diabetes mellitus,, microalbuminuria.
Brief summary
To evaluate the antihypertensive effect of amiloride added to triple antihypertensive therapy in patients with resistant hypertension (RH) and type 2 diabetes mellitus (T2DM)
Detailed description
The primary objective of this study was to evaluate the antihypertensive effect of amiloride added to triple antihypertensive treatment in patients with resistant hypertension and type 2 diabetes mellitus in an open-labelled, non- controlled and non-randomized interventional study. The secondary objectives were to evaluate the additional effects of amiloride on: * Urinary albumin excretion * Blood pressure control, how many patients reached blood pressure control when amiloride was added to previous triple antihypertensive treatment. * Plasminogen and plasmin excretion (ENaC activity) in the micro-and macroalbuminuric patients in the cohort. * Urokinase plasminogen activator (uPA) activity
Interventions
DRUGAmiloride
5 mg(daily of amiloride was added to patients triple antihypertensive therapy and increased to 10 mg/daily if office blood pressure at 4 weeks was above 130/80 mmHg.
Sponsors
Ib Abildgaard Jacobsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed with resistant hypertension (average daytime BP \>130and/or \>80 mmHg by ambulatory monitoring in spite of treatment with 3 antihypertensive drugs including a diuretic and an angiotensin coverting enzyme inhibitor (AECi) or angiotensin recpetor blocker (ARBs) and a third optional, all in optimal dosages. * type 2 diabetes * prior participant in a randomized controlled trial with spironolactone, but after a wash-out periods of minimum two weeks (NCT01062763)
Exclusion criteria
* Office blood pressure (BP) \>180/110 mmHg * daytime average BP by ambulatory monitoring \> 170/85 mmHg * heart failure (NYHA III-IV) Cardiac arrythmia HbA1C \> 10% severe dyslipidemia known or with signs of secondary hypertension estimated glomerular filtration rate (eGFR) \<50ml/min per 1.73 m2 prior intolerance to spironolactone or amiloride fertility without oral contraception pregnancy lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| average daytime systolic and diastolic blood pressure | 8 weeks | ambulatory blood pressure monitoring was performed at baseline and after 8 weeks intervention with amiloride |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary albumin excretion | after 8 weeks | Urine albumin was measured at baseline and after 8 weeks of amiloride treatment. |
| plasma potassium | after 4 and 8 weeks | plasma potassium tend to increase during amiloride treatment |
| urinary urokinase plasminogen activator (uPA) activity | At baseline and after 8 weeks of amiloride treatment | uPA exist in urine where it cleaves plasminogen to plasmin. uPA is possible secreted fra the tubulus cells |
| urine plasminogen and plasmin | at baseline and after 8 weeks of amiloride treatment | U-plasminogen is filtered to urine in patients with microalbuminuria. In urine plasminogen is activated to plasmin by urokinase plasminogen activator.Plasmin activates the epithelial sodium channel. |
Countries
Denmark
Outcome results
None listed