HFpEF patients have impaired peripheral microvascular function compared to controls without HFpEF, with correction for important confounders of microvascular function.
ID
Source
Brief title
Condition
- Heart failures
Health condition
Heart Failure with preserved Ejection Fraction (HFpEF)
Research involving
Sponsors and support
Intervention
- Other intervention
Outcome measures
Primary outcome
Secondary outcome
- Additional analyses similarly performed include finger capillary recruitment, and sublingual glycocalyx assessment
- Difference in macrovascular function assessed by carotid-femoral pulse wave velocity, intima-media thickness ratio, or ankle/arm-index in HFpEF patients compared to control individuals, corrected for the most important confounders of microvascular function and HFpEF.
- Difference in physical activity assessed by the modified Champs questionnaire in HFpEF patients compared to control individuals, corrected for the most important confounders of microvascular function and HFpEF.
Background summary
About 142.000 individuals in the Netherlands have the diagnosis heart failure. About 50% of these people have heart failure with preserved ejection fraction (HFpEF). HFpEF is a complex syndrome with a high morbidity and mortality. The incidence of HFpEF has increased the past decennium with 1% per year. The diversity in clinical phenotype and limited understanding of the underlying pathophysiology of HFpEF is one of the most important reasons why we have no effective therapy to date. The heterogeneity of HFpEF could potentially be the puzzle in which we find a therapy. It is therefore important to extensively map HFpEF patients to clarify which elements are deflected and how these elements interact with each other. Based on multiple studies the current hypothesis is that microvascular dysfunction plays a key role in the development of HFpEF, the evidence in HFpEF patients is increasing but still limited. With this study we intend to further clarify the peripheral microvascular function in HFpEF patients in a non-invasive manner. Results of this study can give additional information regarding phenotypes of HFpEF and potentially offer a new therapeutical window.
Study objective
HFpEF patients have impaired peripheral microvascular function compared to controls without HFpEF, with correction for important confounders of microvascular function.
Study design
1
Intervention
Age
Inclusion criteria
Patients with HFpEF were eligible to participate in this study based on the following inclusion criteria:
- HFpEF diagnosis based on the European Society of Cardiology (ESC) heart failure 2016 guidelines’ diagnostic criteria.
- Aged 60 years or older.
Controls
Data of controls already participating in the Maastricht Study was used. All controls signed informed consent prior to using their data for the current study.
Controls were selected based on the following inclusion criteria:
- Aged 60 years or older
- Data available of primary endpoint
Exclusion criteria
- 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 were excluded based on the following criteria:
- A history of HF at baseline or HF during one-year follow-up after baseline.
- Suspected severe cardiac valve disease or decreased left ventricular ejection fraction during baseline echocardiography. Or if no echocardiography was performed.
- Inclusion as HFpEF patient in the current study.
Design
Recruitment
IPD sharing statement
Plan description
Postbus 5800
6202 AZ Maastricht
043 387 6009
secretariaat.metc@mumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7655 |
| CCMO | NL68796.068.19 |
| OMON | NL-OMON55466 |