The Correlation Between Filling Pressure, Cardiac Output... | NCT01748006

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

NCT01748006

Sponsor

Finn Gustafsson

Status

Unknown status

Last Update Posted

Oct 28, 2015Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Heart Failure

Interventions

Standard of care therapy for severe decompensated heart failure

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 2016Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

Aug 15, 2012

First Submission Date that Met QC Criteria

Dec 10, 2012

First Posted Date

Dec 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2015

Last Update Posted Date

Oct 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Blood and urine samples			Other: Standard of care therapy for severe decompensated heart failure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard of care therapy for severe decompensated heart failure	Other		Blood and urine samples

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The correlation between levels of plasma copeptin and vasopressin with left ventricular filling pressure and cardiac output		Day 1

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Finn Gustafsson, MD, DMSc	Contact	004535459743		finng@dadlnet.dk
Louise Balling, MD	Contact	004535452142		louise.balling@dadlnet.dk

Overall Officials

Name	Affiliation	Role
Finn Gustafsson, MD, DMSc	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet	Recruiting	Copenhagen			Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30058349	Derived	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.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases