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The Correlation Between Filling Pressure, Cardiac Output and Plasma Copeptin in Patients With Systolic Heart Failure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Finn Gustafsson, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01748006
First Posted: December 12, 2012
Last Update Posted: October 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Finn Gustafsson, Rigshospitalet, Denmark
August 15, 2012
December 12, 2012
October 28, 2015
June 2012
June 2016   (Final data collection date for primary outcome measure)
The correlation between levels of plasma copeptin and vasopressin with left ventricular filling pressure and cardiac output [ Time Frame: Day 1 ]
Same as current
Complete list of historical versions of study NCT01748006 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Correlation Between Filling Pressure, Cardiac Output and Plasma Copeptin in Patients With Systolic Heart Failure
The Correlation Between Filling Pressure, Cardiac Output and Plasma Copeptin in Patients With Systolic Heart Failure

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Blood and urine analyses
Non-Probability Sample
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.
Heart Failure
Other: Standard of care therapy for severe decompensated heart failure
Blood and urine samples
Intervention: Other: Standard of care therapy for severe decompensated heart failure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
June 2016
June 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age > 18 years
  2. Left ventricular ejection fraction < 40 %
  3. Diagnosed symptomatic heart failure treated with heart failure medications for at least 30 days.
  4. Clinical indication for right heart catheterization for clinical/treatment reasons
  5. NYHA-class III-IV
  6. Relevant heart failure treatment as tolerated by the patient

Exclusion Criteria:

  1. Absence of clinical/treatment indication of right heart catheterization
  2. Syndrome of Inappropriate Secretion of ADH (SIADH)
  3. Recent acute myocardial infarction within the last 30 days
  4. Presence of infection or inflammatory disease
  5. Malignant disease
  6. Pregnancy
  7. Subjects unwilling or unable to provide written consent
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01748006
H-1-2012-019
No
Not Provided
Not Provided
Finn Gustafsson, Rigshospitalet, Denmark
Finn Gustafsson
Not Provided
Principal Investigator: Finn Gustafsson, MD, DMSc Rigshospitalet, Denmark
Rigshospitalet, Denmark
October 2015