Amiloride for Resistant Hypertension

• Sponsor: Ib Abildgaard Jacobsen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02122731
• Collaborator: (none)
• Enrollment: 80
• Locations: 4
• Arm: 1
• Duration (Months): 21
• Patients Per Site: 20
• Patients Per Site Per Month: 1

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Type 2 Diabetes Mellitus; Microalbuminuria	Drug: Amiloride	Phase 4

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Southern Danish Hypertension and Diabetes Study (SDHDS) With Amiloride
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amiloride This is a non-randomized and non-controlled study with only one treatment arm with amiloride.	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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Urinary albumin excretion [after 8 weeks]

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

2. plasma potassium [after 4 and 8 weeks]

   plasma potassium tend to increase during amiloride treatment

3. 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

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sydvestjysk Hospital, Esbjerg	Esbjerg		Denmark
2	Sygehus Lillebaelt.	Fredericia		Denmark
3	Steno Diabetes Center	Gentofte		Denmark
4	Odense University Hospital, Department of Endocrinology	Odense		Denmark

Sponsors and Collaborators

• Ib Abildgaard Jacobsen

Investigators

• Principal Investigator: Ib A Jacobsen, DMSc, Odense University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Ib Abildgaard Jacobsen, Consultant Physician, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT02122731
• Other Study ID Numbers: EudraCT 2009-017033
• First Posted: Apr 24, 2014
• Last Update Posted: Apr 24, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Ib Abildgaard Jacobsen, Consultant Physician, Odense University Hospital: antihypertensive therapy; amiloride; add-on; resistant hypertension; blood pressure control; type 2 diabetes mellitus,; microalbuminuria.
• Additional relevant MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2; Amiloride

Study Results

No Results Posted as of Apr 24, 2014