The effect of spironolactone on kidney function in patients with high blood pressure

The effect of spironolactone on renal hemodynamics in patients with essential hypertension

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001636-60-DK

Enrollment

Registered

2019-05-13

Start date

2019-07-12

Completion date

Unknown

Last updated

2022-03-28

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

Conditions

Physiological responses in patients with essential hypertension MedDRA version: 20.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Cardiogen-82 Product Name: Rubidium-82 chloride Pharmaceutical Form: Radionuclide generator INN or Proposed INN: NA CAS Number: 8000049-30-1 Other descriptive name: RUBIDIUM (82 RB) Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 40-80 years, BMI 18,5-30,0 kg/m2, fertile women must use contraception, hypertension, signed consent form 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: Alcohol abuse, substance abuse, tobacco smoking, cancer, pregnancy or nursing, diabetes mellitus, GFR 700 mg/l, clinically significant signs of lung-, liver-, metabolic or neurologic disorders, clinically significant abnormalities in screening blood tests, urine tests or ECG, clinical signs of secondary hypertension, treatment with more than 3 different types of antihypertensives, office blood pressure > 170/105 repeatedly despite regulaion og antihypertensive medicine, donation of blood within one month of the first examination day, uacceptable symptoms due to high blood pressure

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect af treatment with spironolactone for 4 weeks renal hemodynamics in patients with essentiel hypertension;Secondary Objective: Not applicable;Primary end point(s): Renal blood flow;Timepoint(s) of evaluation of this end point: At the end of the trial when all subjects have completed the trial	—

Secondary

Measure	Time frame
Secondary end point(s): Renal plasma flow Renal vascular resistance Brachial blood pressure and central aortic systolic blood pressure, pulsewavevelocity, vascular stiffness Creatinine clearance, filtrationfraction Plasma levels of renin, aldosteron, angiotensin 2, atrial natriuretic peptide, brain natriuretic peptide, cGMP, Nox, nitrate, nitrite, vasopressin, osmolality, potassium, sodium, creatinine, albumin Urinary excretion of cGMP, cAMP, aquaporin 2, Enac, NKCC2, Nox, nitrate, nitrite, osmolality, potassium, sodium, creatinine, albumin;Timepoint(s) of evaluation of this end point: At the end of the trial when all subjects have completed the trial	—

Measure

Time frame

Secondary end point(s): Renal plasma flow Renal vascular resistance Brachial blood pressure and central aortic systolic blood pressure, pulsewavevelocity, vascular stiffness Creatinine clearance, filtrationfraction Plasma levels of renin, aldosteron, angiotensin 2, atrial natriuretic peptide, brain natriuretic peptide, cGMP, Nox, nitrate, nitrite, vasopressin, osmolality, potassium, sodium, creatinine, albumin Urinary excretion of cGMP, cAMP, aquaporin 2, Enac, NKCC2, Nox, nitrate, nitrite, osmolality, potassium, sodium, creatinine, albumin;Timepoint(s) of evaluation of this end point: At the end of the trial when all subjects have completed the trial

—

Countries

Denmark

Contacts

Public ContactStine Sundgaard Langaa

University clinic of Nephrology and Hypertension, Regional Hospital Holstebro

stinlg@rm.dk004578436587

Outcome results

None listed

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