Clinical trial NCT01748006: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: The correlation between levels of plasma copeptin and vasopressin with left ventricular filling pressure and cardiac output
timeFrame: Day 1
Secondary outcomes:
measure: The correlation between levels of plasma copeptin and vasopressin with urine aquaporin-2 concentration
timeFrame: Day 1
measure: The correlation between New York Heart Association (NYHA) class and levels of plasma copeptin and vasopressin
timeFrame: Day 1
measure: The correlation between biomarkers levels and survival free of transplantation- and left ventricular assist device insertion
timeFrame: 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Cardiology, Copenhagen University Hospital, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Finn Gustafsson, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.