Amiloride for Resistant Hypertension

Ib Abildgaard Jacobsen80 enrolled

Overview

To evaluate the antihypertensive effect of amiloride added to triple antihypertensive therapy in patients with resistant hypertension (RH) and type 2 diabetes mellitus (T2DM)

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension Type 2 Diabetes Mellitus Microalbuminuria

Interventions

AmilorideDRUG

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (4)

Sydvestjysk Hospital, Esbjerg

Esbjerg, Denmark

Sygehus Lillebaelt.

Fredericia, Denmark

Steno Diabetes Center

Gentofte Municipality, Denmark

Odense University Hospital, Department of Endocrinology

Odense, Denmark

Outcomes

Primary Outcomes

average daytime systolic and diastolic blood pressure

ambulatory blood pressure monitoring was performed at baseline and after 8 weeks intervention with amiloride

Time frame: 8 weeks

Secondary Outcomes

Urinary albumin excretion

Urine albumin was measured at baseline and after 8 weeks of amiloride treatment.

Time frame: after 8 weeks

plasma potassium

plasma potassium tend to increase during amiloride treatment

Time frame: after 4 and 8 weeks

urinary urokinase plasminogen activator (uPA) activity

uPA exist in urine where it cleaves plasminogen to plasmin. uPA is possible secreted fra the tubulus cells

Time frame: At baseline and after 8 weeks of amiloride treatment

urine plasminogen and plasmin

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.

Time frame: at baseline and after 8 weeks of amiloride treatment

Data from ClinicalTrials.gov

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