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

• ClinicalTrials.gov Identifier: NCT01748006
• Recruitment Status: Unknown
• First Posted: December 12, 2012
• Last Update Posted: October 28, 2015
• Sponsor: Finn Gustafsson
• 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

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.

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

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