Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Finn Gustafsson, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01748006
First received: August 15, 2012
Last updated: December 10, 2012
Last verified: December 2012

August 15, 2012
December 10, 2012
June 2012
June 2013   (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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • The correlation between New York Heart Association (NYHA) class and levels of plasma copeptin and vasopressin [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • The correlation between biomarkers levels and survival free of transplantation- and left ventricular assist device insertion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
 
Recruiting
30
June 2013
June 2013   (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
Both
18 Years to 80 Years
No
Contact: Finn Gustafsson, MD, DMSc 004535459743 finng@dadlnet.dk
Contact: Louise Balling, MD 004535452142 louise.balling@dadlnet.dk
Denmark
 
NCT01748006
H-1-2012-019
No
Finn Gustafsson, Rigshospitalet, Denmark
Finn Gustafsson
Not Provided
Principal Investigator: Finn Gustafsson, MD, DMSc Rigshospitalet, Denmark
Rigshospitalet, Denmark
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP