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

NCT ID: NCT01748006

Last Updated: 2015-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Blood and urine samples

Standard of care therapy for severe decompensated heart failure

Intervention Type OTHER

Interventions

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Standard of care therapy for severe decompensated heart failure

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Finn Gustafsson

OTHER

Sponsor Role lead

Responsible Party

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Finn Gustafsson

MD, DMSc

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Finn Gustafsson, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Department of Cardiology, Copenhagen University Hospital, Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Finn Gustafsson, MD, DMSc

Role: CONTACT

004535459743

Louise Balling, MD

Role: CONTACT

004535452142

Facility Contacts

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Finn Gustafsson, MD, PhD, DMSc

Role: primary

004535459743

Louise Balling, MD

Role: backup

004535452142

References

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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.

Reference Type DERIVED
PMID: 30058349 (View on PubMed)

Other Identifiers

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H-1-2012-019

Identifier Type: -

Identifier Source: org_study_id

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