Amiloride for Resistant Hypertension

Ib Abildgaard Jacobsen

Status and phase: Completed; Phase 4

Conditions: Hypertension; Type 2 Diabetes Mellitus; Microalbuminuria

Treatments: Drug: Amiloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02122731

EudraCT 2009-017033

Details and patient eligibility

About

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

Full 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

Enrollment: 80 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Amiloride

Experimental group

Description:

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

Treatment:

Drug: Amiloride