Heart FailureNCT01748006
The Correlation Between Filling Pressure, Cardiac Output and Plasma Copeptin in Patients With Systolic Heart Failure
An observational study of Heart Failure, run by Finn Gustafsson at 1 site in Denmark.
Trial summary
The relationship between the activation of the vasopressin system and central hemodynamics in heart failure (including right and left heart filling pressures and cardiac output) is not clear. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2012to Jun 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of 30 patients with heart failure admitted to the Department of Cardiology at the Copenhagen University Hospital, Rigshospitalet,Dennmark. Only patients who are already referred to right heart catheterization by the attending cardiologist will be recruited for the study.
Who may be able to join
- Age > 18 years
- Left ventricular ejection fraction < 40 %
- Diagnosed symptomatic heart failure treated with heart failure medications for at least 30 days.
- Clinical indication for right heart catheterization for clinical/treatment reasons
- NYHA-class III-IV
- Relevant heart failure treatment as tolerated by the patient
Who cannot join
- Absence of clinical/treatment indication of right heart catheterization
- Syndrome of Inappropriate Secretion of ADH (SIADH)
- Recent acute myocardial infarction within the last 30 days
- Presence of infection or inflammatory disease
- Malignant disease
- Pregnancy
- Subjects unwilling or unable to provide written consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet
Copenhagen
Finn Gustafsson, MD, PhD, DMSc, 004535459743, finng@dadlnet.dk
Louise Balling, MD, 004535452142, louise.balling@dadlnet.dk
About this study
The relationship between the activation of the vasopressin system and central hemodynamics in heart failure (including right and left heart filling pressures and cardiac output) is not clear. The investigators intend to examine the correlation between levels of copeptin and vasopressin and the central hemodynamic system in patients with advanced (class III or IV) heart failure. The investigators also aim to examine the relationship of selected cardiac biomarkers in blood and urine with cardiac filling pressures and cardiac output in patients with decompensated heart failure.
The study population will consist of 30 patients admitted to the Department of Cardiology at Copenhagen University Hospital. Only patients for whom the attending cardiologist has already decided upon right heart catheterization for clinical/treatment reasons will be recruited for the study.
- Conditions
- Heart Failure
- Being tested
- Standard of care therapy for severe decompensated heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care therapy for severe decompensated heart failureOther
| Study group | Role | What they receive |
|---|---|---|
| Blood and urine samples | Not described Receives: Other: Standard of care therapy for severe decompensated heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between levels of plasma copeptin and vasopressin with left ventricular filling pressure and cardiac output
Measured: Day 1
Secondary outcomes (3)
The correlation between levels of plasma copeptin and vasopressin with urine aquaporin-2 concentration
Measured: Day 1
The correlation between New York Heart Association (NYHA) class and levels of plasma copeptin and vasopressin
Measured: Day 1
The correlation between biomarkers levels and survival free of transplantation- and left ventricular assist device insertion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finn Gustafsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Finn Gustafsson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Finn Gustafsson, MD, DMSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748006
- Sponsor's protocol ID
- H-1-2012-019
- Status last verified
- Oct 2015
- First submitted
- 15 Aug 2012
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Balling L, Goetze JP, Jung MH, Rossing K, Boesgaard S, Gustafsson F. Copeptin levels and invasive hemodynamics in patients with advanced heart failure. Biomark Med. 2018 Aug;12(8):861-870. doi: 10.2217/bmm-2017-0439. Epub 2018 Jul 30.
PubMed 30058349
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Filling Pressure, Cardiac Output and Plasma Copeptin in Patients With Systolic Heart Failure
- ClinicalTrials.gov ID
- NCT01748006
- Acronym / sponsor ID
- H-1-2012-019
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Finn GustafssonUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 12 Dec 2012 (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 relationship between the activation of the vasopressin system and central hemodynamics in heart failure (including right and left heart filling pressures and cardiac output) is not clear. The investigators intend to examine the correlation between levels of copeptin and vasopressin and the central hemodynamic system in patients with advanced (class III or IV) heart failure. The investigators also aim to examine the relationship of selected cardiac biomarkers in blood and urine with cardiac filling pressures and cardiac output in patients with decompensated heart failure.
The study population will consist of 30 patients admitted to the Department of Cardiology at Copenhagen University Hospital. Only patients for whom the attending cardiologist has already decided upon right heart catheterization for clinical/treatment reasons will be recruited for the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood and urine samples | – | Other: Standard of care therapy for severe decompensated heart failure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 30 patients with heart failure admitted to the Department of Cardiology at the Copenhagen University Hospital, Rigshospitalet,Dennmark. Only patients who are already referred to right heart catheterization by the attending cardiologist will be recruited for the study.
Key inclusion criteria (6 listed)
- Age > 18 years
- Left ventricular ejection fraction < 40 %
- Diagnosed symptomatic heart failure treated with heart failure medications for at least 30 days.
- Clinical indication for right heart catheterization for clinical/treatment reasons
- NYHA-class III-IV
Key exclusion criteria (7 listed)
- Absence of clinical/treatment indication of right heart catheterization
- Syndrome of Inappropriate Secretion of ADH (SIADH)
- Recent acute myocardial infarction within the last 30 days
- Presence of infection or inflammatory disease
- Malignant disease
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 |
|---|---|---|
| Standard of care therapy for severe decompensated heart failure | Other | Blood and urine samples |
Primary outcome
The correlation between levels of plasma copeptin and vasopressin with left ventricular filling pressure and cardiac output
Time frame: Day 1
3 secondary outcomes
The correlation between levels of plasma copeptin and vasopressin with urine aquaporin-2 concentration
Time frame: Day 1
The correlation between New York Heart Association (NYHA) class and levels of plasma copeptin and vasopressin
Time frame: Day 1
The correlation between biomarkers levels and survival free of transplantation- and left ventricular assist device insertion
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- Derived from this study: PubMed 30058349Balling L, Goetze JP, Jung MH, Rossing K, Boesgaard S, Gustafsson F. Copeptin levels and invasive hemodynamics in patients with advanced heart failure. Biomark Med. 2018 Aug;12(8):861-870. doi: 10.2217/bmm-2017-0439. Epub 2018 Jul 30.
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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.
Finn Gustafsson, MD, DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Heart Failure, run by Finn Gustafsson 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 6 inclusion and 7 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 28 Oct 2015. 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 Finn Gustafsson, MD, DMSc (004535459743, finng@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between levels of plasma copeptin and vasopressin with left ventricular filling pressure and cardiac output (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01748006, which also lists 1 linked publication.
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 28 Oct 2015; AzTrials last refreshed its copy on 6 Nov 2026.