Amiloride for Resistant Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-08-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Hypertension Type 2 Diabetes Mellitus Microalbuminuria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amiloride

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

Group Type EXPERIMENTAL

Amiloride

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No