Clinical trial NCT02122731: Amiloride for Resistant Hypertension
Official title: Southern Danish Hypertension and Diabetes Study (SDHDS) With Amiloride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Type 2 Diabetes Mellitus
Microalbuminuria
Keywords: antihypertensive therapy
amiloride
add-on
resistant hypertension
blood pressure control
type 2 diabetes mellitus,
microalbuminuria.
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: average daytime systolic and diastolic blood pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Urinary albumin excretion
timeFrame: after 8 weeks
measure: plasma potassium
timeFrame: after 4 and 8 weeks
measure: urinary urokinase plasminogen activator (uPA) activity
timeFrame: At baseline and after 8 weeks of amiloride treatment
measure: urine plasminogen and plasmin
timeFrame: at baseline and after 8 weeks of amiloride treatment
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Sydvestjysk Hospital, Esbjerg
city: Fredericia
country: Denmark
facility: Sygehus Lillebaelt.
city: Gentofte
country: Denmark
facility: Steno Diabetes Center
city: Odense
country: Denmark
facility: Odense University Hospital, Department of Endocrinology
Study officials:
affiliation: Odense University Hospital
name: Ib A Jacobsen, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oxlund CS, Henriksen JE, Tarnow L, Schousboe K, Gram J, Jacobsen IA. Low dose spironolactone reduces blood pressure in patients with resistant hypertension and type 2 diabetes mellitus: a double blind randomized clinical trial. J Hypertens. 2013 Oct;31(10):2094-102. doi: 10.1097/HJH.0b013e3283638b1a.