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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
Sponsor:
Information provided by (Responsible Party):
Finn Gustafsson, Rigshospitalet, Denmark

Tracking Information
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
 (submitted: December 10, 2012)
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
 (submitted: December 10, 2012)
  • 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 ]
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood and urine analyses
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
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.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 10, 2012)
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:

  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
Sex/Gender
Sexes Eligible for Study: All
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
Principal Investigator: Finn Gustafsson, MD, DMSc Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date October 2015