Water- and Salt-homeostasis in Healthy Humans, and in Patients With Heart- or Lung Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|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|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Observational Model:||Case Control|
|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|
U.S. FDA Resources
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.
Patients with symptomatic aortic valve stenosis
Procedure: Aortic valve replacement
Standard aortic valve replacement as per standard criteria in the department of thoracic surgery.
Patients with Acute Coronary syndromes prior to surgical intervention
Procedure: Revascularisation in Acute Coronary Syndrome
Standard percutaneous or surgical revascularisation in ACS.
Patients with refractory stable angina requiring surgical intervention.
Procedure: Revascularisation in chronic stable angina pectoris
Standard percutaneous or surgical revascularisation
Patients with pulmonary hypertension and preserved systolic left ventricular function.
- Differences in excretion of Aquaporin-2 in urine [ Time Frame: 6 months ]
- Differences in excretion of Epithelial Sodium Channels in urine [ Time Frame: 6 months ]
Biospecimen Retention: Samples Without DNA
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
|Contact: Ole Nyvad, M.D.||+45 email@example.com|
|Kolding, Denmark, DK-6000|
|Contact: Bodil Feldthaus, RN 76362142 firstname.lastname@example.org|
|Principal Investigator: Ole Nyvad, M.D.|
|Principal Investigator:||Ole Nyvad, M.D.||Kolding Hospital, Kolding, Denmark|