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

Evaluation of Heart Failure with preserved Ejection Fraction and peripheral microvascular dysfunction - HFpEF and peripheral microcirculation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55466

Enrollment

1850

Registered

2019-04-03

Start date

2019-04-25

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

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Countries

Netherlands

Outcome results