The effect of Amiloride and Spironolacton on renophysiological and cardiovascular parametres in patients with hypertension - HASS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020599-47-DK

Enrollment

Registered

2010-05-25

Start date

2010-06-29

Completion date

Unknown

Last updated

2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension MedDRA version: 12.1 Level: LLT Classification code 10004254 Term: Benign essential hypertension

Interventions

Trade Name: Amiloride Product Name: Amiloride Pharmaceutical Form: Tablet INN or Proposed INN: AMILORIDE HYDROCHLORIDE CAS Number: 2016888 Concentration unit: mg/g milligram(s)/gram Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • hypertension: bloodpressure between 135/85 and 160/100 • male and female • Age 45-70 years • BMI between 18,5-30,0 kg/m2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Secundary hypertension • Previous AMI, atrielfibrillation, heartdisease,cardiac-insufficiency. • Previous apoplexia • Lungdisease, liver disease, kidneydisease, hormone imbalances, brain brain-disease or cancer • Alcoholabuse • Drugabuse • Medical treatment exept contraceptives • Smoking • Pregnancy or breastfeeding • Lack of wish to participate • Abnormal blood or urine samples • Abnormal ECG • Blooddonation within the last month

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate a possible effect of potassium on the bloodpressure level;Secondary Objective: To investigate the renal function and waterchannels in the kidney;Primary end point(s): The effect of amiloride and spironolactone on: 1. Renal function (GFR, u-AQP2, u-ENaCß, u-cAMP, u-PGE2, CH20, FENa, FEK), 2. Pulsewavevelocity, augmentation index and central bloodpressure, 3. Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP andEndot), and 4. 24 hour bloodpressure	—

Measure

Time frame

Main Objective: To investigate a possible effect of potassium on the bloodpressure level;Secondary Objective: To investigate the renal function and waterchannels in the kidney;Primary end point(s): The effect of amiloride and spironolactone on: 1. Renal function (GFR, u-AQP2, u-ENaCß, u-cAMP, u-PGE2, CH20, FENa, FEK), 2. Pulsewavevelocity, augmentation index and central bloodpressure, 3. Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP andEndot), and 4. 24 hour bloodpressure

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026