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

NCT ID: NCT00830726

Last Updated: 2011-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers Heart Failure Aortic Stenosis Ischemic Heart Disease Pulmonary Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Healthy volunteers

No interventions assigned to this group

2

Patients with symptomatic heart failure and EF \< 40%

Pharmacologic and mechanical heart failure treatment

Intervention Type DRUG

Optimised, standard, evidence based heart failure therapy including the use of biventricular pacing.

3

Patients with symptomatic aortic valve stenosis

Aortic valve replacement

Intervention Type PROCEDURE

Standard aortic valve replacement as per standard criteria in the department of thoracic surgery.

4

Patients with Acute Coronary syndromes prior to surgical intervention

Revascularisation in Acute Coronary Syndrome

Intervention Type PROCEDURE

Standard percutaneous or surgical revascularisation in ACS.

5

Patients with refractory stable angina requiring surgical intervention.

Revascularisation in chronic stable angina pectoris

Intervention Type PROCEDURE

Standard percutaneous or surgical revascularisation

6

Patients with pulmonary hypertension and preserved systolic left ventricular function.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pharmacologic and mechanical heart failure treatment

Optimised, standard, evidence based heart failure therapy including the use of biventricular pacing.

Intervention Type DRUG

Aortic valve replacement

Standard aortic valve replacement as per standard criteria in the department of thoracic surgery.

Intervention Type PROCEDURE

Revascularisation in Acute Coronary Syndrome

Standard percutaneous or surgical revascularisation in ACS.

Intervention Type PROCEDURE

Revascularisation in chronic stable angina pectoris

Standard percutaneous or surgical revascularisation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Regionshospitalet Holstebro, Holstebro, Denmark

UNKNOWN

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Kolding Sygehus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kolding Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ole Nyvad, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kolding Hospital, Kolding, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kolding Hospital

Kolding, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ole Nyvad, M.D.

Role: CONTACT

+45 76362257

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bodil Feldthaus, RN

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S-20080141

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fibrosis and the Fontan
NCT04901975 RECRUITING PHASE1/PHASE2