Our goal is to build up a deep phenotyped HFpEF cohort, to be able to select the right patients for different HFpEF studies with the final goal of improving the understanding of the pathophysiology of HFpEF. The HFpEF cohort will allow us to…
ID
Source
Brief title
Condition
- Other condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Health condition
hartaandoeningen, falen van de hartfunctie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) Set up a cohort of HFpEF patients with an detailed clinical
characterization of their phenotype.
Secondary outcome
2. Set up a cohort of HFpEF patients with detailed clinical characterization of
their phenotype.
3. Set up a biobank, to analyse different biomarker profiles which will help to
stratify HFpEF patients
4. Investigate if patients without HFpEF, hypertensive controls that will be
included in the *HFpEF-cohort perfusion and metabolism study*( NL57468.068.16/
METC162032) have different biomarker profiles compared to the HFpEF patients.
5. Isolate monocytes, neutrophils, T cells and platelets in HFpEF and
hypertensive control patients included in the *HFpEF-cohort perfusion and
metabolism study* (NL57468.068.16/METC162032) to understand better the
pathophysiology, phenotype HFpEF patients and assess the differences with
patients without HFpEF.
6. Evaluate the changes in biomarker, urine and cellular expression (monocytes,
neutrophils, T cells and platelets) after one year of all HFpEF patients
included in the cohort and clinically followed up in out out-patient clinic.
Evaluate whether our personalized, multidisciplinary treatment strategy
improves quality of life and exercise tolerability, and reduces
hospitalizations
7. Increase awareness around this challenging syndrome.
8. Evaluate platelet function by analysing extracellular vesicles in blood of
hypertensive control patients that in future projects will be compared to HFpEF
patients.
Background summary
Heart failure with preserved ejection fraction (HFpEF) is a complex syndrome,
with high morbidity and mortality. In the last decade, with 1% of incidence
increase per year, HFpEF has become a health care problem of epidemic
proportion.
Patient characteristics of HFpEF differ from HFrEF. HFpEF patients are likely
to be older, more often female, have a higher body mass index and are more
likely to be obese. Cardiovascular and non-cardiovascular comorbidities are
highly associated with HFpEF including diabetes, atrial fibrillation (AF) and
hypertension and may significantly contribute to the patients* symptoms.
Recently a new paradigm for the development of HFpEF has been proposed, which
identifies a systemic pro-inflammatory state induced by comorbidities as the
origin of microvascular endothelial cell inflammation and subsequent concentric
cardiac remodelling and dysfunction.
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. Targeted,
instead of a one-size-fits-all, treatment seems the only promising approach for
treating HFpEF. To be able to design a targeted, phenotype-specific HFpEF
treatment, the matrix relating clinical phenotypes and underlying
pathophysiological mechanisms has to be clarified.
Study objective
Our goal is to build up a deep phenotyped HFpEF cohort, to be able to select
the right patients for different HFpEF studies with the final goal of improving
the understanding of the pathophysiology of HFpEF. The HFpEF cohort will allow
us to understand the relationship between the different comorbidities and the
clinical outcome.
Moreover, the HFpEF cohort will allow us to select the right patients to
included in phase 2 and 3 medical trials.
We also want to analyse if the analysis of different blooed, of urine biomarker
profiles will help to stratify HFpEF patients. Moreover, we will include 20
control hypertensive patients as a control group to be able to analyse the
difference in clinical parameters and biomarkers between HFpEF and hypertensive
patients.
Study design
This is a single centre study, to recruit a prospective cohort of HFpEF
patients and 20 hypertensive control patients. To assess the discriminative
value of biomarkers for the diagnosis and prognosis of HFPEF we will use an
already existing control group of patients without heart failure. Blood samples
for biomarker profiling and cell isolation (monocytes, neutrophils, T cells and
platelets) and urine samples of HFpEF patients will be obtained at the moment
that these patients are being screened in the HFpEF outpatient clinic and after
one year a follow up biobank screening will be performed. We will also include
20 control hypertensive patient*s blood and urine samples in our biobank. From
the blood analysis we will also isolate cells (monocytes, neutrophils, T cells,
extracellular vesicles and platelets). These hypertensive control patients do
not have HFpEF and they will not be further followed up. The reason of the
inclusion of these 20 control patients is to be able to compare the results of
age and comorbidity compared HFpEF patients with their blood and urine
biomarker profiling. Further follow up does not add any additional value to
this comparison. The reason why extracellular vesicles are only isolated from
hypertensive control patients is that almost all HFpEF patients already have
been include in the *HFpEF-cohort perfusion and metabolism
study* (NL57468.068.16/METC162032), but the 20 hypertensive controls have still
to be included. The result of these blood analysis, included the extracellular
vesicle isolation will be compared to HFpEF patients in future projects.
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
All patients referred with exertional dyspnea to the HFpEF clinic from the
general HF, general cardiology outpatient clinic or directly from their general
practitioners above 18 years that have the ability to give the informed consent
and sign it will be included in the cohort and blood and urine samples for the
biobank will be obtained. , 20 hypertensive control patients will be included.
These are their inclusion criteria:
o Age > 50 years
o Estimated glomerular filtration reserve (eGFR) >30 ml/min
o Body weight<130kg
o No coronary artery disease (CAD; coronary stenosis>70% or history of CABG)
o No heart failure
o Preserved left ventricular ejection fraction (LVEF) (>= 50%) on
echocardiography
o No left ventricular hypertrophy (lateral and septal left ventricular wall
=<10mm)
o No left atrium enlargement
o No diastolic dysfunction type 2 or 3
o Blood pressure >140/90 mmHg or use of anti-hypertensive therapy
o Normal cardiac structure and function on echocardiography
Exclusion criteria
- Inability to give informed consent or refusal to participate in the study
- Age <18 years.
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 | NL67997.068.18 |