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

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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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

Conditions
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Healthy Volunteers, Heart Failure, Aortic Stenosis, Ischemic Heart Disease, Pulmonary Hypertension

Intervention / Treatment
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* Drug: Pharmacologic and mechanical heart failure treatment
* Procedure: Aortic valve replacement
* Procedure: Revascularisation in Acute Coronary Syndrome
* Procedure: Revascularisation in chronic stable angina pectoris


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aquaporin, Epithelial Sodium Channels, Heart Failure, Valvular heart disease, Ischemic heart disease