Evaluation of Heart Failure with preserved Ejection Fraction and peripheral microvascular dysfunctio

Completed

Conditions: bloedvataandoeningen, verminderde functie van microcirculatie
Heart failure with preserved ejection fraction
heart failure with preserved pump function
10019280

Registration Number: NL-OMON55466

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 2278

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is peripheral microvascular function assessed by<br /><br>flicker-light induced retinal microvascular %-dilation measured with Dynamic<br /><br>Vessel Analyzer, corrected for the most important confounders of microvascular<br /><br>function.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Difference in peripheral microvascular function assessed by heat-induced skin<br /><br>hyperaemia, finger capillary recruitment, or glycocalyx assessment in HFpEF<br /><br>patients compared to matched controls.<br /><br>- Difference in macrovascular function assessed by carotid-femoral pulse wave<br /><br>velocity, intima-media thickness ratio, or ankle/arm-index in HFpEF patients<br /><br>compared to matched controls.<br /><br>- Difference in physical activity assessed by the modified Champs questionnaire<br /><br>in HFpEF patients compared to matched controls.</p><br>