The Correlation Between Filling Pressure, Cardiac Output and Plasma Copeptin in Patients With Systolic Heart Failure
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ClinicalTrials.gov Identifier: NCT01748006 |
Recruitment Status : Unknown
Verified October 2015 by Finn Gustafsson, Rigshospitalet, Denmark.
Recruitment status was: Recruiting
First Posted : December 12, 2012
Last Update Posted : October 28, 2015
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Tracking Information | ||||
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First Submitted Date | August 15, 2012 | |||
First Posted Date | December 12, 2012 | |||
Last Update Posted Date | October 28, 2015 | |||
Study Start Date | June 2012 | |||
Estimated Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
The correlation between levels of plasma copeptin and vasopressin with left ventricular filling pressure and cardiac output [ Time Frame: Day 1 ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | The Correlation Between Filling Pressure, Cardiac Output and Plasma Copeptin in Patients With Systolic Heart Failure | |||
Official Title | The Correlation Between Filling Pressure, Cardiac Output and Plasma Copeptin in Patients With Systolic Heart Failure | |||
Brief 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. 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. |
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Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: Blood and urine analyses
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Sampling Method | Non-Probability Sample | |||
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. | |||
Condition | Heart Failure | |||
Intervention | Other: Standard of care therapy for severe decompensated heart failure | |||
Study Groups/Cohorts | Blood and urine samples
Intervention: Other: Standard of care therapy for severe decompensated heart failure
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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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
30 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | June 2016 | |||
Estimated Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Denmark | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01748006 | |||
Other Study ID Numbers | H-1-2012-019 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Finn Gustafsson, Rigshospitalet, Denmark | |||
Study Sponsor | Finn Gustafsson | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Rigshospitalet, Denmark | |||
Verification Date | October 2015 |