NCT02122731

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2014

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

1.7 years

First QC Date

April 23, 2014

Last Update Submit

April 23, 2014

Conditions

HypertensionType 2 Diabetes MellitusMicroalbuminuria

Keywords

antihypertensive therapyamilorideadd-onresistant hypertensionblood pressure controltype 2 diabetes mellitus,microalbuminuria.

Outcome Measures

Primary Outcomes (1)

  • average daytime systolic and diastolic blood pressure

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

    8 weeks

Secondary Outcomes (4)

  • Urinary albumin excretion

    after 8 weeks

  • plasma potassium

    after 4 and 8 weeks

  • urinary urokinase plasminogen activator (uPA) activity

    At baseline and after 8 weeks of amiloride treatment

  • urine plasminogen and plasmin

    at baseline and after 8 weeks of amiloride treatment

Study Arms (1)

Amiloride

EXPERIMENTAL

This is a non-randomized and non-controlled study with only one treatment arm with amiloride.

Drug: Amiloride

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.

Amiloride

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sydvestjysk Hospital, Esbjerg

Esbjerg, Denmark

Location

Sygehus Lillebaelt.

Fredericia, Denmark

Location

Steno Diabetes Center

Gentofte Municipality, Denmark

Location

Odense University Hospital, Department of Endocrinology

Odense, Denmark

Location

Related 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.

    PMID: 24107738BACKGROUND

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 2

Interventions

Amiloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ib A Jacobsen, DMSc

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant Physician

Study Record Dates

First Submitted

April 23, 2014

First Posted

April 24, 2014

Study Start

November 1, 2010

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations

DK(4)