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

Heart Failure Clinical Trial

Official title:

Water-and Salt-homeostasis in Healthy Humans, and in Patients With Heart- or Lung Disease, Evaluated by the Excretion of Aquaporin-2 and Epithelial Sodium Channels in the Urine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00830726
• Other study ID #: S-20080141
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2009
• Last updated: June 22, 2011
• Start date: February 2009
• Est. completion date: February 2012

Study information

• Verified date: June 2011
• Source: Kolding Sygehus
• Contact: Ole Nyvad, M.D.
• Phone: +45 76362257
• Email: ole.nyvad[@]slb.regionsyddanmark.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Coronary Artery Disease
• Healthy Volunteers
• Heart Diseases
• Heart Failure
• Hypertension, Pulmonary
• Ischemic Heart Disease
• Lung Diseases
• Myocardial Ischemia
• Pulmonary Hypertension

Intervention

Drug:
• Pharmacologic and mechanical heart failure treatment
Optimised, standard, evidence based heart failure therapy including the use of biventricular pacing.

Procedure:
• Aortic valve replacement
Standard aortic valve replacement as per standard criteria in the department of thoracic surgery.
• Revascularisation in Acute Coronary Syndrome
Standard percutaneous or surgical revascularisation in ACS.
• Revascularisation in chronic stable angina pectoris
Standard percutaneous or surgical revascularisation

Locations

Country	Name	City	State
Denmark	Kolding Hospital	Kolding

Sponsors (3)

Lead Sponsor	Collaborator
Kolding Sygehus	Odense University Hospital, Regionshospitalet Holstebro, Holstebro, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in excretion of Aquaporin-2 in urine		6 months	No
Secondary	Differences in excretion of Epithelial Sodium Channels in urine		6 months	No