Healthy VolunteersNCT00830726
Water- and Salt-homeostasis in Healthy Humans, and in Patients With Heart- or Lung Disease
An observational study of Healthy Volunteers and Heart Failure, run by Kolding Sygehus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Heart Failure, Aortic Stenosis
- What is being tested?
- Pharmacologic and mechanical heart failure treatment, Aortic valve replacement and Revascularisation in Acute Coronary Syndrome
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2009to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers and Outpatients and admitted patients in Kolding Hospital and Odense Universitetshospital
Who may be able to join
- Symptomatic heart failure
- Severe valvular aortic stenosis
- Acute Coronary Syndrome
- Medically refractory chronic angina pectoris or pulmonary hypertension with preserved left ventricular function
Who cannot join
- Pregnancy
- Drug abuse
- Malignant disease
- Significant disease of other organs including endocrine diseases
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Kolding Hospital
Kolding, DK-6000
Bodil Feldthaus, RN, 76362142, bodfel@fks.vejleamt.dk
Ole Nyvad, M.D.
About this study
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
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.
Read the 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)
- Conditions
- Healthy Volunteers, Heart Failure, Aortic Stenosis, Ischemic Heart Disease, Pulmonary Hypertension
- Being tested
- Pharmacologic and mechanical heart failure treatment, Aortic valve replacement, Revascularisation in Acute Coronary Syndrome, Revascularisation in chronic stable angina pectoris
- Keywords
- Aquaporin, Epithelial Sodium Channels, Heart Failure, Valvular heart disease, Ischemic heart disease
- Medical subject headings
- Heart Failure, Aortic Valve Stenosis, Myocardial Ischemia, Hypertension, Pulmonary, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacologic and mechanical heart failure treatmentDrug
Optimised, standard, evidence based heart failure therapy including the use of biventricular pacing.
Aortic valve replacementProcedure or surgery
Standard aortic valve replacement as per standard criteria in the department of thoracic surgery.
Revascularisation in Acute Coronary SyndromeProcedure or surgery
Standard percutaneous or surgical revascularisation in ACS.
Revascularisation in chronic stable angina pectorisProcedure or surgery
Standard percutaneous or surgical revascularisation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy volunteers | |
| 2 | Patients with symptomatic heart failure and EF < 40% Receives: Drug: Pharmacologic and mechanical heart failure treatment | |
| 3 | Patients with symptomatic aortic valve stenosis Receives: Procedure: Aortic valve replacement | |
| 4 | Patients with Acute Coronary syndromes prior to surgical intervention Receives: Procedure: Revascularisation in Acute Coronary Syndrome | |
| 5 | Patients with refractory stable angina requiring surgical intervention. Receives: Procedure: Revascularisation in chronic stable angina pectoris | |
| 6 | Patients with pulmonary hypertension and preserved systolic left ventricular function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in excretion of Aquaporin-2 in urine
Measured: 6 months
Secondary outcomes (1)
Differences in excretion of Epithelial Sodium Channels in urine
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kolding Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Holstebro, Holstebro, Denmark, Odense University Hospital
- Investigators
- Ole Nyvad, M.D., Principal investigator, Kolding Hospital, Kolding, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830726
- Sponsor's protocol ID
- S-20080141
- Status last verified
- Jun 2011
- First submitted
- 26 Jan 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00830726
- Acronym / sponsor ID
- S-20080141
- Conditions
- Healthy Volunteers, Heart Failure, Aortic Stenosis, Ischemic Heart Disease, Pulmonary Hypertension
- Keywords
- Aquaporin, Epithelial Sodium Channels, Heart Failure, Valvular heart disease, Ischemic heart disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kolding SygehusUniversity, hospital or other
- Collaborators
- Regionshospitalet Holstebro, Holstebro, Denmark, Odense University Hospital
- Study start
- Feb 2009
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy volunteers |
| 2 | – | Drug: Pharmacologic and mechanical heart failure treatmentPatients with symptomatic heart failure and EF < 40% |
| 3 | – | Procedure: Aortic valve replacementPatients with symptomatic aortic valve stenosis |
| 4 | – | Procedure: Revascularisation in Acute Coronary SyndromePatients with Acute Coronary syndromes prior to surgical intervention |
| 5 | – | Procedure: Revascularisation in chronic stable angina pectorisPatients with refractory stable angina requiring surgical intervention. |
| 6 | – | –Patients with pulmonary hypertension and preserved systolic left ventricular function. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and Outpatients and admitted patients in Kolding Hospital and Odense Universitetshospital
Key inclusion criteria (4 listed)
- Symptomatic heart failure
- Severe valvular aortic stenosis
- Acute Coronary Syndrome
- Medically refractory chronic angina pectoris or pulmonary hypertension with preserved left ventricular function
Key exclusion criteria (4 listed)
- Pregnancy
- Drug abuse
- Malignant disease
- Significant disease of other organs including endocrine diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacologic and mechanical heart failure treatmentOptimised, standard, evidence based heart failure therapy including the use of biventricular pacing. | Drug | 2 |
| Aortic valve replacementStandard aortic valve replacement as per standard criteria in the department of thoracic surgery. | Procedure or surgery | 3 |
| Revascularisation in Acute Coronary SyndromeStandard percutaneous or surgical revascularisation in ACS. | Procedure or surgery | 4 |
| Revascularisation in chronic stable angina pectorisStandard percutaneous or surgical revascularisation | Procedure or surgery | 5 |
Primary outcome
Differences in excretion of Aquaporin-2 in urine
Time frame: 6 months
1 secondary outcome
Differences in excretion of Epithelial Sodium Channels in urine
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Nyvad, M.D. principal investigator
Kolding Hospital, Kolding, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers and Heart Failure, run by Kolding Sygehus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ole Nyvad, M.D. (+45 76362257, ole.nyvad@slb.regionsyddanmark.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in excretion of Aquaporin-2 in urine (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.