Effects of Acutely Elevated Afterload on Left Ventricular Contractility and Relaxation

NCT ID: NCT02751853

Last Updated: 2022-09-10

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

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2022-08-31

Brief Summary

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Aim of the study is to assess the effects of abruptly increased afterload on left ventricular contractility and relaxation in patients with heart failure with preserved ejection fraction (HFPEF), patients with heart failure with reduced ejection fraction (HFREF), and patients without HFPEF or HFREF.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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HFPEF

Patient with heart failure with preserved ejection fraction (HFPEF)

Group Type EXPERIMENTAL

Conductance catheter

Intervention Type DEVICE

Continuous online measurements of left ventricular pressure and volume using conductance catheters

HFREF

Patient with heart failure with reduced ejection fraction (HFREF)

Group Type EXPERIMENTAL

Conductance catheter

Intervention Type DEVICE

Continuous online measurements of left ventricular pressure and volume using conductance catheters

No HFPEF/HFREF

Patient without heart failure with preserved ejection fraction (HFPEF) or heart failure with reduced ejection fraction (HFREF)

Group Type ACTIVE_COMPARATOR

Conductance catheter

Intervention Type DEVICE

Continuous online measurements of left ventricular pressure and volume using conductance catheters

Interventions

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Conductance catheter

Continuous online measurements of left ventricular pressure and volume using conductance catheters

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinical indication for left and right heart catheterization
* HFPEF (Group 1) OR HFREF (Group 2) OR absent echocardiographic evidence of HFREF OR HFPEF(Group 3)

AND

* Sinus rhythm during invasive measurements
* Age ≥18 years
* Negative pregnancy test in women with childbearing potential
* Written informed consent

Exclusion Criteria

* Acute coronary syndrome
* Acute myocardial infarction \<6 months
* Planned cardiac surgery or cardiovascular intervention within 6 months following inclusion
* Valvular heart disease \>2°
* Severe comorbidities with limited life expectancy \<12 months
* Precapillary pulmonary hypertension
* Participation in another trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Holger Thiele

Director, Department of Cardiology, Angiology, and Intensive Care Medicine, University Heart Center Luebeck

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

Other Identifiers

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16-011

Identifier Type: -

Identifier Source: org_study_id

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