Research with human participants

Overview of medical research in the Netherlands

Impact of arterio-venous fistulas on cardiac contractility in hemodialysis patients evaluated using cardiac magnetic resonance derived functional and geometrical parameters

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Last updated:

To perform a detailed non-invasive analysis of mechanical activation under different volume loading conditions and to describe the accompanying hemodynamic response.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Heart failures
Study type
Observational non invasive

ID

NL-OMON43002

Source

ToetsingOnline

Brief title

Effect of shunt flow on cardiac contractility in hemodialysis patients

Condition

  • Heart failures
  • Renal disorders (excl nephropathies)

Synonym

cardiac contractility, cardiac function

Research involving

Human

Sponsors and support

Primary sponsor :
Onze Lieve Vrouwe Gasthuis
Source(s) of monetary or material Support :
Vakgroep Interne Geneeskunde

Intervention

Keyword :
AV shunt, cardiac MRI, contractility, hemodialysis

Outcome measures

Primary outcome

Mechanical activation pattern of the human heart and the accompanying

hemodynamic response.

Secondary outcome

n/a

Background summary

The pathway of mechanical activation of the human heart is altered by volume
overload, as encountered in hemodialysis patients. Assessment and analysis of
these alterations have been challenging throughout the years. Recent
technological innovations allow non-invasive (in-vivo) mapping of mechanical
activation patterns of the human heart. Improved insight in these activation
patterns and the associated hemodynamic response may contribute to better
medical treatment and optimized follow-up strategies in this patient group.

Study objective

To perform a detailed non-invasive analysis of mechanical activation under
different volume loading conditions and to describe the accompanying
hemodynamic response.

Study design

Prospective, observational, follow-up study. Study duration has been defined as
a maximum of two years follow-up.

Study burden and risks

Although non-invasive, CMR can cause nausea, headache or general discomfort,
especially in subjects suffering from claustrophobia.

Public
Onze Lieve Vrouwe Gasthuis

Jan Tooropstraat 164
Amsterdam 1061AE
NL
Scientific
Onze Lieve Vrouwe Gasthuis

Jan Tooropstraat 164
Amsterdam 1061AE
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Patients at least 18 years of age.
Patients undergoing hemodialysis.

Exclusion criteria

Unable to give informed consent.
Any contraindication for MRI, e.g. claustrophobia.
Weight > 200 kilo.
Participation in another clinical trial.
Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.

Design

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Basic science

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
45
Type :
Anticipated

Approved WMO
Date :
Application type :
First submission
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL58898.100.16