Water- and Salt-homeostasis in Healthy Humans, and in Pat... | NCT00830726

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

NCT00830726

Sponsor

Kolding Sygehus

Status

Unknown status

Last Update Posted

Jun 23, 2011Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Healthy Volunteers
Heart Failure
Aortic Stenosis
Ischemic Heart Disease
Pulmonary Hypertension

Interventions

Pharmacologic and mechanical heart failure treatment
Aortic valve replacement
Revascularisation in Acute Coronary Syndrome
Revascularisation in chronic stable angina pectoris

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Feb 2012Estimated

Completion Date

Feb 2012Estimated

First Submitted Date

Jan 26, 2009

First Submission Date that Met QC Criteria

Jan 27, 2009

First Posted Date

Jan 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Kolding SygehusOTHER

Collaborators

Name	Class
Regionshospitalet Holstebro, Holstebro, Denmark	UNKNOWN
Odense University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
1	Healthy volunteers
2	Patients with symptomatic heart failure and EF < 40%	Drug: Pharmacologic and mechanical heart failure treatment
3	Patients with symptomatic aortic valve stenosis	Procedure: Aortic valve replacement
4	Patients with Acute Coronary syndromes prior to surgical intervention	Procedure: Revascularisation in Acute Coronary Syndrome
5	Patients with refractory stable angina requiring surgical intervention.	Procedure: Revascularisation in chronic stable angina pectoris
6	Patients with pulmonary hypertension and preserved systolic left ventricular function.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pharmacologic and mechanical heart failure treatment	Drug	Optimised, standard, evidence based heart failure therapy including the use of biventricular pacing.	2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ole Nyvad, M.D.	Contact	+45 76362257		ole.nyvad@slb.regionsyddanmark.dk

Overall Officials

Name	Affiliation	Role
Ole Nyvad, M.D.	Kolding Hospital, Kolding, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kolding Hospital	Recruiting	Kolding		DK-6000	Denmark

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D001024	Aortic Valve Stenosis
D017202	Myocardial Ischemia
D006976	Hypertension, Pulmonary
D006349	Heart Valve Diseases

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000082862	Aortic Valve Disease
D014694	Ventricular Outflow Obstruction
D014652	Vascular Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension

ID	Term
D019918	Heart Valve Prosthesis Implantation
D006348	Cardiac Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019919	Prosthesis Implantation
D019616	Thoracic Surgical Procedures