The main objective of the HELPFulUP study is to investigate deterioration of the diastolic function towards HFpEF in individuals with pre-clinical LVDD The secondary objective is to relate the progression towards HFpEF to clinical characteristics…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The deterioration of LVDD towards HFpEF (stage C/D heart failure), measured by
(stress) cardiac ultrasonography assessing functional and structural
parameters, combined with natriuretic peptide measurements and clinical
evaluation.
Secondary outcome
Paramaters that are collected for exploratory etiological hypothesis generation
and further phenotyping of the heterogeneous population of patients with
deteriorating diastolic function and HFpEF. Parameters include clinical
factors, echocardiography paramaters (such as global longitudinal strain of the
left ventricle and the left atrium calculated from standard echocardiography
images) and biomarker parameters that can help to explain what individuals in
stage B heart failure are at high risk of progression to stage C/D heart
failure. Promising blood biomarkers (e.g. omics related to vascular
dysfunction) will be measured again, and promising new biomarkers, e.g. BNP
measurements after exercise will be added. To further elaborate the cardiorenal
syndrome within our cohort urine biomarkers will be measured.
Background summary
Heart failure with preserved ejection fraction (HFpEF) is a syndrome with
numerous comorbidities, leads to high hospitalisation rates, and a low
health-related quality of life. The pre-clinical stage is often characterized
by left ventricular diastolic dysfunction (LVDD). The deterioration from LVDD
to HFpEF is more common among women compared to men, whereas the prevalence of
LVDD is equally distributed among both sexes. Currently, it is hard to predict
which individual with (pre-clinical) LVDD (stage B heart failure) has an
elevated risk of developing HFpEF (stage C or D heart failure).
Study objective
The main objective of the HELPFulUP study is to investigate deterioration of
the diastolic function towards HFpEF in individuals with pre-clinical LVDD
The secondary objective is to relate the progression towards HFpEF to clinical
characteristics and additional examinations, as well as to (repeated) biomarker
measurements.
Study design
Longitudinal cohort study.
Study burden and risks
The participants selected for follow-up plus (stress) echocardiography will
have one visit scheduled at the UMC Utrecht that will take maximally 90 minutes
of their time. To the best of our knowledge, the ultrasound waves do not have a
negative health effect, and patients are electrocardiographically monitored
during exercise. For exercise testing there is a very low risk for fatal events
or events occurring that require hospitalisation (event rate 1:10.000). The
risks of a venous blood withdrawal are a local hematoma or infection, and a
vasovagal response. We will also ask the participant to collect urine for
routine measurement and biobank storage.
The potential benefits for participants is that clinically relevant cardiac
abnormalities can be discovered in an early phase of the disease and thus
facilitating early intervention and treatment. To facilitate such management, a
report of the BNP values, ultrasound parameters and its interpretation and
management recommendation will be sent to the patient*s own treating
physician/general practitioner.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Participants of the HELPFul study with a baseline diagnosis of LVDD without
clinical signs or symptoms of heart failure (stage B heart failure)
- Participants consenting to be contacted for follow-up studies of the HELPFul
study
- Participants who are able to read and understand the Dutch language.
- Participants who are willing and able to provide written informed consent for
participation in this study.
- Participants who agreed that results of the follow-up measurements are
reported to the treating physician.
Exclusion criteria
- Participants who received a heart transplantation or left ventricular assist
device (LVAD) in the period between baseline and follow-up.
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 | NL76102.041.21 |