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

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ClinicalTrials.gov Identifier: NCT00830726
Recruitment Status : Unknown
Verified June 2011 by Kolding Sygehus.
Recruitment status was:  Recruiting
First Posted : January 28, 2009
Last Update Posted : June 23, 2011
Sponsor:
Collaborators:
Regionshospitalet Holstebro, Holstebro, Denmark
Odense University Hospital
Information provided by:
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.

Condition or disease Intervention/treatment
Healthy Volunteers Heart Failure Aortic Stenosis Ischemic Heart Disease Pulmonary Hypertension Drug: Pharmacologic and mechanical heart failure treatment Procedure: Aortic valve replacement Procedure: Revascularisation in Acute Coronary Syndrome Procedure: Revascularisation in chronic stable angina pectoris

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 Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Prospective
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
Study Start Date : February 2009
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : February 2012


Group/Cohort Intervention/treatment
1
Healthy volunteers
2
Patients with symptomatic heart failure and EF < 40%
Drug: Pharmacologic and mechanical heart failure treatment
Optimised, standard, evidence based heart failure therapy including the use of biventricular pacing.
3
Patients with symptomatic aortic valve stenosis
Procedure: Aortic valve replacement
Standard aortic valve replacement as per standard criteria in the department of thoracic surgery.
4
Patients with Acute Coronary syndromes prior to surgical intervention
Procedure: Revascularisation in Acute Coronary Syndrome
Standard percutaneous or surgical revascularisation in ACS.
5
Patients with refractory stable angina requiring surgical intervention.
Procedure: Revascularisation in chronic stable angina pectoris
Standard percutaneous or surgical revascularisation
6
Patients with pulmonary hypertension and preserved systolic left ventricular function.



Primary Outcome Measures :
  1. Differences in excretion of Aquaporin-2 in urine [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Differences in excretion of Epithelial Sodium Channels in urine [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
Plasma and Urine samples


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers and Outpatients and admitted patients in Kolding Hospital and Odense Universitetshospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830726


Contacts
Contact: Ole Nyvad, M.D. +45 76362257 ole.nyvad@slb.regionsyddanmark.dk

Locations
Denmark
Kolding Hospital Recruiting
Kolding, Denmark, DK-6000
Contact: Bodil Feldthaus, RN    76362142    bodfel@fks.vejleamt.dk   
Principal Investigator: Ole Nyvad, M.D.         
Sponsors and Collaborators
Kolding Sygehus
Regionshospitalet Holstebro, Holstebro, Denmark
Odense University Hospital
Investigators
Principal Investigator: Ole Nyvad, M.D. Kolding Hospital, Kolding, Denmark

Responsible Party: Ole Nyvad, M.D., Kolding Hospital
ClinicalTrials.gov Identifier: NCT00830726     History of Changes
Other Study ID Numbers: S-20080141
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011

Keywords provided by Kolding Sygehus:
Aquaporin
Epithelial Sodium Channels
Heart Failure
Valvular heart disease
Ischemic heart disease

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Lung Diseases
Hypertension, Pulmonary
Aortic Valve Stenosis
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Respiratory Tract Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases