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

• Conditions: Heart Failure
• Interventions: Other: Standard of care therapy for severe decompensated heart failure

• Registration Number: NCT01748006
• Lead Sponsor: Finn Gustafsson

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 available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-28
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blood and urine samples	Standard of care therapy for severe decompensated heart failure	-

Primary Outcome Measures

Name	Time	Method
The correlation between levels of plasma copeptin and vasopressin with left ventricular filling pressure and cardiac output	Day 1

Secondary Outcome Measures

Name	Time	Method
The correlation between levels of plasma copeptin and vasopressin with urine aquaporin-2 concentration	Day 1
The correlation between biomarkers levels and survival free of transplantation- and left ventricular assist device insertion	1 year
The correlation between New York Heart Association (NYHA) class and levels of plasma copeptin and vasopressin	Day 1

Trial Locations

Locations (1)

Department of Cardiology, Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen, Denmark