Water- and Salt-homeostasis in Healthy Humans, and in Patients With Heart- or Lung Disease

• Conditions: Healthy Volunteers; Heart Failure; Aortic Stenosis; Ischemic Heart Disease; Pulmonary Hypertension
• Interventions: Drug: Pharmacologic and mechanical heart failure treatment; Procedure: Revascularisation in Acute Coronary Syndrome; Procedure: Revascularisation in chronic stable angina pectoris; Procedure: Aortic valve replacement

• Registration Number: NCT00830726
• Lead Sponsor: Kolding Sygehus

Brief Summary

The purpose of the study is to determine whether the excretion of renal water- and salt-channels in the urine reflects the handling of water and salt in the kidneys, and whether the excretion can be used to monitor and/or predict the effects of treatment of certain heart or lung diseases.

Detailed Description

The purpose of the study is to determine whether the excretion of renal water- and salt-channels (Aquaporin-2 and Epithelial Sodium Channels) in the urine accurately reflects the handling of water and salt in the distal tubules af the kidneys, and whether quantification of these channels in the urine is useful to monitor and/or predict the effects of pharmacologic or surgical treatment of Heart Failure and heart failure-related diseases (Aortic stenosis, acute and chronic ischemic heart disease or pulmonary hypertension)

Study Timeline

• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-28
• Study Start: 2009-02
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23
• Primary Completion: 2012-02
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Symptomatic heart failure
• Severe valvular aortic stenosis
• Acute Coronary Syndrome
• Medically refractory chronic angina pectoris or pulmonary hypertension with preserved left ventricular function

Exclusion Criteria

• Pregnancy
• Drug abuse
• Malignant disease
• Significant disease of other organs including endocrine diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	Pharmacologic and mechanical heart failure treatment	Patients with symptomatic heart failure and EF \< 40%
4	Revascularisation in Acute Coronary Syndrome	Patients with Acute Coronary syndromes prior to surgical intervention
5	Revascularisation in chronic stable angina pectoris	Patients with refractory stable angina requiring surgical intervention.
3	Aortic valve replacement	Patients with symptomatic aortic valve stenosis

Primary Outcome Measures

Name	Time	Method
Differences in excretion of Aquaporin-2 in urine	6 months

Secondary Outcome Measures

Name	Time	Method
Differences in excretion of Epithelial Sodium Channels in urine	6 months

Trial Locations

Locations (1)

Kolding Hospital; 🇩🇰 Kolding, Denmark