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NCT Number: NCT02122731

Amiloride for Resistant Hypertension

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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Key information

Conditions

Hypertension Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Microalbuminuria Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sydvestjysk Hospital, Esbjerg, Esbjerg, Denmark

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amiloride

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Urinary albumin excretion

    Time frame: after 8 weeks

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

  2. plasma potassium

    Time frame: after 4 and 8 weeks

    plasma potassium tend to increase during amiloride treatment

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Ib Abildgaard Jacobsen

Other

Registry information

Official study title

Southern Danish Hypertension and Diabetes Study (SDHDS) With Amiloride

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 24, 2014
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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