To identify differences in peripheral microvascular function in HFpEF patients compared to controls without HFpEF, corrected for important confounders of microvascular function
ID
Source
Brief title
Condition
- Other condition
- Heart failures
Synonym
Health condition
bloedvataandoeningen, verminderde functie van microcirculatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is peripheral microvascular function assessed by
flicker-light induced retinal microvascular %-dilation measured with Dynamic
Vessel Analyzer, corrected for the most important confounders of microvascular
function.
Secondary outcome
- Difference in peripheral microvascular function assessed by heat-induced skin
hyperaemia, finger capillary recruitment, or glycocalyx assessment in HFpEF
patients compared to matched controls.
- Difference in macrovascular function assessed by carotid-femoral pulse wave
velocity, intima-media thickness ratio, or ankle/arm-index in HFpEF patients
compared to matched controls.
- Difference in physical activity assessed by the modified Champs questionnaire
in HFpEF patients compared to matched controls.
Background summary
The diversity in clinical phenotypes and poor understanding of the underlying
pathophysiology of heart failure with preserved ejection fraction (HFpEF) is
the main reason why no effective treatments have been found yet.
Microcirculation dysfunction is thought to play a central role in development
of HFpEF, evidence of this concept is increasing. Moreover, it is unclear
whether microvascular function differences lead to the observed higher
prevalence of HFpEF in women.
Study objective
To identify differences in peripheral microvascular function in HFpEF patients
compared to controls without HFpEF, corrected for important confounders of
microvascular function
Study design
This is a case-control study. Peripheral microvascular and macrovascular
assessments are performed within the Maastricht Study infrastructure and comply
with previously approved Standard Operating Procedures (SOP*s). Clinical data
resulted from clinical diagnostic tests performed during standard clinical care
will be collected for characterization of the study population and for pooled
analysis.
Study burden and risks
There is not any risk associated with the participation in this study.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
HFpEF patients:
- HFpEF diagnosis based on ESC 2016 diagnostic criteria.
- Aged 60 years or older., Controls with diabetes mellitus:
- Diabets mellitus diagnosis based on World Health Organization 2006 criteria.
- Aged 60 years or older., Controls without DM:
- No diabets mellitus diagnosis based on World Health Organization 2006
criteria.
- Aged 60 years or older.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
HFpEF patients:
- Inability to give informed consent.
- Contraindications for pupil dilation by ocular drips, which is needed for the
primary endpoint of this study assessed by flicker-light induced retinal vessel
reactivity: a history of acute glaucoma, previous allergic reaction to ocular
dilation drips. pregnancy or giving breastfeeding, current presence of
intraocular oil or gas after retinal detachment.
- Contraindication for flicker-light induced retinal vessel reactivity
assessment: history of photosensitive epilepsy.,
Controls with diabetes mellitus:
- A history of heart failure.
Controls without diabetes mellitus:
- A history of heart failure.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL68796.068.19 |
| OMON | NL-OMON23162 |