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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
  Purpose

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.


Condition Intervention Phase
Heart Failure Other: Standard of care therapy for severe decompensated heart failure Early Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Correlation Between Filling Pressure, Cardiac Output and Plasma Copeptin in Patients With Systolic Heart Failure

Resource links provided by NLM:


Further study details as provided by Finn Gustafsson, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • The correlation between levels of plasma copeptin and vasopressin with left ventricular filling pressure and cardiac output [ Time Frame: Day 1 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA
Blood and urine analyses

Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Blood and urine samples Other: Standard of care therapy for severe decompensated heart failure

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748006


Contacts
Contact: Finn Gustafsson, MD, DMSc 004535459743 finng@dadlnet.dk
Contact: Louise Balling, MD 004535452142 louise.balling@dadlnet.dk

Locations
Denmark
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Finn Gustafsson, MD, PhD, DMSc    004535459743    finng@dadlnet.dk   
Contact: Louise Balling, MD    004535452142    louise.balling@dadlnet.dk   
Principal Investigator: Finn Gustafsson, MD, PhD, DMSc         
Sponsors and Collaborators
Finn Gustafsson
Investigators
Principal Investigator: Finn Gustafsson, MD, DMSc Rigshospitalet, Denmark
  More Information

Responsible Party: Finn Gustafsson, MD, DMSc, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01748006     History of Changes
Other Study ID Numbers: H-1-2012-019
First Submitted: August 15, 2012
First Posted: December 12, 2012
Last Update Posted: October 28, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases