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

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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Aortic Stenosis; Healthy Volunteers; Ischemic Heart Disease; Pulmonary Hypertension
• Intervention / Treatment: 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
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Denmark
  • Kolding, Denmark, DK-6000
    • Recruiting
    • Kolding Hospital
    • Contact: Bodil Feldthaus, RN; Phone Number: 76362142; Email: bodfel@fks.vejleamt.dk
    • Principal Investigator: Ole Nyvad, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and Outpatients and admitted patients in Kolding Hospital and Odense Universitetshospital

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Differences in excretion of Aquaporin-2 in urine	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Differences in excretion of Epithelial Sodium Channels in urine	6 months

Collaborators and Investigators

• Sponsor: Kolding Sygehus
• Collaborators: Odense University Hospital; Regionshospitalet Holstebro, Holstebro, Denmark
• Investigators: Principal Investigator: Ole Nyvad, M.D., Kolding Hospital, Kolding, Denmark

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Anticipated): February 1, 2012
• Study Completion (Anticipated): February 1, 2012

Study Registration Dates

• First Submitted: January 26, 2009
• First Submitted That Met QC Criteria: January 27, 2009
• First Posted (Estimate): January 28, 2009

Study Record Updates

• Last Update Posted (Estimate): June 23, 2011
• Last Update Submitted That Met QC Criteria: June 22, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Heart Failure; Ischemic heart disease; Valvular heart disease; Aquaporin; Epithelial Sodium Channels
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Hypertension; Heart Failure; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Lung Diseases; Aortic Valve Stenosis; Hypertension, Pulmonary
• Other Study ID Numbers: S-20080141