Amiloride for Resistant Hypertension

April 23, 2014 updated by: Ib Abildgaard Jacobsen

Southern Danish Hypertension and Diabetes Study (SDHDS) With Amiloride

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Esbjerg, Denmark
        • Sydvestjysk Hospital, Esbjerg
      • Fredericia, Denmark
        • Sygehus Lillebaelt.
      • Gentofte, Denmark
        • Steno Diabetes center
      • Odense, Denmark
        • Odense University Hospital, Department of Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
average daytime systolic and diastolic blood pressure
Time Frame: 8 weeks
ambulatory blood pressure monitoring was performed at baseline and after 8 weeks intervention with amiloride
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary albumin excretion
Time Frame: after 8 weeks
Urine albumin was measured at baseline and after 8 weeks of amiloride treatment.
after 8 weeks
plasma potassium
Time Frame: after 4 and 8 weeks
plasma potassium tend to increase during amiloride treatment
after 4 and 8 weeks
urinary urokinase plasminogen activator (uPA) activity
Time Frame: 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
At baseline and after 8 weeks of amiloride treatment
urine plasminogen and plasmin
Time Frame: 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.
at baseline and after 8 weeks of amiloride treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ib Abildgaard Jacobsen

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

April 23, 2014

First Submitted That Met QC Criteria

April 23, 2014

First Posted (Estimate)

April 24, 2014

Study Record Updates

Last Update Posted (Estimate)

April 24, 2014

Last Update Submitted That Met QC Criteria

April 23, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2009-017033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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