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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Kolding Sygehus.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Regionshospitalet Holstebro, Holstebro, Denmark
Odense University Hospital
Information provided by:
Kolding Sygehus
ClinicalTrials.gov Identifier:
NCT00830726
First received: January 26, 2009
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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 Intervention
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
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Kolding Sygehus:

Primary Outcome Measures:
  • Differences in excretion of Aquaporin-2 in urine [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences in excretion of Epithelial Sodium Channels in urine [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma and Urine samples


Estimated Enrollment: 150
Study Start Date: February 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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)

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ole Nyvad, M.D., Kolding Hospital
ClinicalTrials.gov Identifier: NCT00830726     History of Changes
Other Study ID Numbers: S-20080141
Study First Received: January 26, 2009
Last Updated: June 22, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on August 27, 2014