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Completed

NCT Number: NCT00438945

The Effect of Eprosartan on Hormones and Kidney Function in Patients With Essential Hypertension

We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan reduces the activity of the sympathetic nervous system in patients with essential hypertension - during baseline conditions and after activation of the sympathetic nervous system.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Medical Research, Holstebro Hospital

Holstebro, 7500, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 - 65 years.
  • Body mass index less or equal to 30 kg/m2.
  • Women must use oral hormonal anticonceptive drugs, use intrauterine anticonceptive device, be sterilized / hysterectomized or be postmenopausal.
  • Arterial hypertension, defined by 24 hour ambulatory blood pressure above 125 mmHg systolic or above 80 mmHg diastolic.

Exclusion criteria

  • History of myocardial infarction.
  • History of stroke.
  • Heart failure.
  • Endocrine organ disease.
  • Lung disease.
  • Clinically significant abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine (under 200 µmol/L will be accepted), P-albumin, p-bilirubin, p-alaninaminotransferase, P-alkaline phosphatase, p-cholesterol and B-glucose.
  • Clinically significant abnormal screening of the urine regarding: albumin and glucose (protein excretion below 0.5 g/L will be accepted).
  • Renovascular hypertension.
  • Malignant disease.
  • Alcohol abuse.
  • Usage of medical drugs besides antihypertensives or statins.
  • Drug abuse.
  • Pregnancy or breast feeding.
  • Known intolerance or allergic to eprosartan or sodium nitroprusside.
  • Blood donation within 1 month of the start of the study.

Treatment and study plan

Eprosartan

Drug

Primary outcomes

  1. Heart rate

  2. Fractional sodium excretion

  3. Plasma levels of noradrenaline

Secondary outcomes

  1. Fractional lithium excretion

  2. Glomerular filtration rate

  3. plasma levels of renin, angiotensin II, aldosterone, vasopressin, atrial natriuretic peptide and brain natriuretic peptide

  4. free water clearance

  5. urinary excretion of aquaporin 2

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Registry information

Official study title

The Effect of Eprosartan in Patients With Essential Hypertension on Renal Tubular Function and Vasoactive Hormones During Baseline Conditions and After Activation of the Sympathetic Nervous System.

Important dates

Study start
2007
Study completion
2008
First posted
Feb 22, 2007
Registry last updated
May 9, 2008

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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