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

NCT01748006 | Unknown

• 1 other identifier: H-1-2012-019
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• The correlation between levels of plasma copeptin and vasopressin with left ventricular filling pressure and cardiac output

  Day 1

Secondary Outcomes (3)

• The correlation between levels of plasma copeptin and vasopressin with urine aquaporin-2 concentration

  Day 1

• The correlation between New York Heart Association (NYHA) class and levels of plasma copeptin and vasopressin

  Day 1

• The correlation between biomarkers levels and survival free of transplantation- and left ventricular assist device insertion

  1 year

Study Arms (1)

Blood and urine samples

Other: Standard of care therapy for severe decompensated heart failure

Interventions

Standard of care therapy for severe decompensated heart failure OTHER

Blood and urine samples

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \> 18 years
• Left ventricular ejection fraction \< 40 %
• Diagnosed symptomatic heart failure treated with heart failure medications for at least 30 days.
• Clinical indication for right heart catheterization for clinical/treatment reasons
• NYHA-class III-IV
• Relevant heart failure treatment as tolerated by the patient

You may not qualify if:

• Absence of clinical/treatment indication of right heart catheterization
• Syndrome of Inappropriate Secretion of ADH (SIADH)
• Recent acute myocardial infarction within the last 30 days
• Presence of infection or inflammatory disease
• Malignant disease
• Pregnancy
• Subjects unwilling or unable to provide written consent

Sponsors & Collaborators

• Finn Gustafsson: lead

Study Sites (1)

Department of Cardiology, Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 30058349 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine analyses

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Finn Gustafsson, MD, DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Finn Gustafsson, MD, DMSc

CONTACT

004535459743; finng@dadlnet.dk

Louise Balling, MD

CONTACT

004535452142; louise.balling@dadlnet.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, DMSc

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: December 12, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

DK (1)