The aim of the proposed study is to examine whether CRT has a positive effect on microvascular function and health outcomes, and whether psychological factors may moderate the effect of CRT on health outcomes.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: Microvascular function as measured by blood flow response to
endothelium-dependent and endothelium-independent vasoactieve stimuli
(acetylcholine, nitroprusside, local heating); health status; cardiac symptoms;
health care consumption.
Secondary outcome
Secondary: Mortality; morbidity (defined as hospitalisation for cardiac
reasons).
The primary endpoint, health care consumption, and the secondary endpoints,
mortality and morbidity, will be assessed at T4 (i.e. 14 months post-CRT), with
the information being obtained through the patients* medical records.
Background summary
In chronic heart failure (CHF), the heart is no longer capable of pumping
sufficient blood to fulfil the nutritional and oxygen needs of organs and
tissues. Also, microvascular function is compromised. A subgroup of CHF
patients can be treated with cardiac synchronization therapy (CRT), eventually
CRT combined with an Implantable Cardioverter Defibrillator (ICD). However, the
effects of CRT on microvascular function are not known. Furthermore, not all
patients experience improvements following CRT, and it is important to gain
knowledge about clinical and psychological parameters that predict poor health
outcomes in post-CRT patients.
Study objective
The aim of the proposed study is to examine whether CRT has a positive effect
on microvascular function and health outcomes, and whether psychological
factors may moderate the effect of CRT on health outcomes.
Study design
This is a single-centre observational prospective study.
Study burden and risks
The tests are non-invasive, and painless. Extra visits to the hospital will be
reduced to a minimum, because appointments for the proposed study will be
scheduled together with standard pacemaker check-ups. For determination of
microvascular functioning, vasoactive drugs will be administered transdermally
in very low dosages which yield no systemic side-effects. Therefore, there is
minimal risk and minimal burden to patients associated with this study.
Postbus 90107
5000 LA Tilburg
NL
Postbus 90107
5000 LA Tilburg
NL
Listed location countries
Age
Inclusion criteria
diagnosis ofchronic heart failure with a left ventricular ejection fraction of 40% or less
being on optimal medical therapy
NYHA functional class III/IV
QRS duration of >=120msec
In addition, at least one of the following echocardiographic criteria has to be fulfilled: an aortic pre-ejection delay>140msec, an interventricular mechanical delay>40 msec, or delayed activation of the posterolateral left ventricular wall
Exclusion criteria
Inability to read, write or understand Dutch, a history of psychiatric illness other than mood disorders (depression/anxiety), significant cognitive impairments (e.g. dementia) or life-treating co morbidities (e.g. cancer).
Design
Recruitment
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 | NL19332.028.07 |