The Effect of Dihydralazine on Kidney Function and Hormones in Healthy Individuals

Phase 4

Completed

• Conditions: Healthy

• Registration Number: NCT00311974
• Lead Sponsor: Regional Hospital Holstebro

Brief Summary

We, the investigators at Holstebro Hospital, want to test the hypothesis that dihydralazine leads to the activation of the sympathetic nervous system in healthy individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-05
• Study First Submitted QC: 2006-04-05
• Study First Posted: 2006-04-07
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-17
• Last Update Posted: 2010-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

1. Men
2. Ages 18 to 40 years.
3. Body mass index less than or equal to 30 kg/m2

Exclusion Criteria

1. History or clinical signs of heart, lung, kidney, or endocrine organ disease.
2. Abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumin, P-bilirubin, P-alanine aminotransferase, P-alkaline phosphatase, P-cholesterol, and B-glucose.
3. Abnormal screening of the urine regarding: albumin and glucose
4. Malignant disease.
5. Known arterial hypertension or measured 24 hour blood pressure above 135 mmHg systolic or 85 mmHg diastolic.
6. Alcohol abuse.
7. Smoking.
8. Drug use or abuse.
9. Known intolerance or allergy to dihydralazine
10. Blood donation within 1 month of the start of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Fractional sodium excretion
Heart rate
Blood pressure

Trial Locations

Locations (1)

Department of Medical Research, Holstebro Hospital; 🇩🇰 Holstebro, Denmark