Amiloride for Resistant Hypertension

Hypertension Clinical Trial

Official title:

Southern Danish Hypertension and Diabetes Study (SDHDS) With Amiloride

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122731
• Other study ID #: EudraCT 2009-017033
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2014
• Last updated: April 23, 2014
• Start date: November 2010
• Est. completion date: August 2012

Study information

• Verified date: April 2014
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: National Board of Health
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Microalbuminuria
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Amiloride
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.

Locations

Country	Name	City	State
Denmark	Sydvestjysk Hospital, Esbjerg	Esbjerg
Denmark	Sygehus Lillebaelt.	Fredericia
Denmark	Steno Diabetes Center	Gentofte
Denmark	Odense University Hospital, Department of Endocrinology	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Ib Abildgaard Jacobsen

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average daytime systolic and diastolic blood pressure	ambulatory blood pressure monitoring was performed at baseline and after 8 weeks intervention with amiloride	8 weeks	Yes
Secondary	Urinary albumin excretion	Urine albumin was measured at baseline and after 8 weeks of amiloride treatment.	after 8 weeks	Yes
Secondary	plasma potassium	plasma potassium tend to increase during amiloride treatment	after 4 and 8 weeks	Yes
Secondary	urinary urokinase plasminogen activator (uPA) activity	uPA exist in urine where it cleaves plasminogen to plasmin. uPA is possible secreted fra the tubulus cells	At baseline and after 8 weeks of amiloride treatment	No
Secondary	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.	at baseline and after 8 weeks of amiloride treatment	No