Primary Objective:- To investigate the association between temporal evolutions of blood biomarkers and clinical adverse events, in order to produce a dynamic, individual, and accurate prediction model for patients with HFpEFSecondary Objective(s):-…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is a combined endpoint of urgent visit resulting in
intravenous therapy for HF, hospital readmission for acute or worsened HF, and
cardiovascular death.
Secondary outcome
The secondary endpoints are:
- the separate components of the combined primary endpoint; urgent visit
resulting in intravenous therapy for heart failure, hospital readmission for
acute or worsened HF, and cardiovascular death.
- The combined endpoint urgent visit resulting in intravenous therapy for HF,
hospital readmission for acute or worsened HF, and all-cause death.
- All-cause death
- Myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal),
percutaneous coronary intervention (PCI) and coronary artery bypass grafting
(CABG)
- Cardiovascular disease (includes all of the above, except all-cause death)
Background summary
Heart failure with preserved ejection fraction (HFpEF) is a dynamic,
heterogeneous clinical syndrome. Its prognosis is just as ominous as that of
heart failure with reduced ejection fraction (HFrEF), with approx. 50%
mortality in the first five years after diagnosis. There is much to gain in the
assessment of individual prognosis of HFpEF patients, in order to contribute to
better timing of additional treatment and therefore to a more favourable
disease course. Repeated blood biomarker measurements may detect unfavourable
changes before they become clinically apparent, and could herewith contribute
to improved risk assesment. Moreover, blood biomarkers could be used to derive
HFpEF sub-phenotypes with differences in clinical characteristics and
prognosis. Such protein-based sub-phenotyping could help us gain further
insights into the underlying pathophysiological mechanisms of HFpEF.
Study objective
Primary Objective:
- To investigate the association between temporal evolutions of blood
biomarkers and clinical adverse events, in order to produce a dynamic,
individual, and accurate prediction model for patients with HFpEF
Secondary Objective(s):
- To describe temporal evolution of biomarkers in patients that experience the
primary endpoint and in patients that do not
- To uncover HFpEF sub-phenotypes based on baseline levels and temporal
evolutions of blood biomarkers
- To investigate differences in clinical characteristics and prognosis of these
HFpEF sub-phenotypes.
- To obtain insights into underlying pathophysiological mechanisms of HFpEF,
based on these sub-phenotypes.
Study design
This is a prospective, observational multi-center cohort study. It will be
conducted at the Cardiology departments of the Erasmus Medical Center (EMC) as
well as five peripheral hospitals. A total of 200 HFpEF patients will be
included in the study through the outpatient clinics. The follow-up period is a
minimum of 2 years and a maximum of 3.5 years. Clinical data will be collected
at baseline, and blood samples will be repeatedly collected, at baseline
followed by 6-month intervals. Protein measurements will be performed at the
end of follow-up.
Study burden and risks
The regular treatment of the patients will not be interfered with as this is an
observational study. The main burden of this study consists of 5 to 8 visits to
the outpatient clinic during 2 to 3.5 years of follow-up. However, by combining
the study visits with planned outpatient clinic visits as much as possible,
extra visits will be kept to a minimum. Procedures during the extra study
visits include venipuncture and also baseline echocardiography. Risks
associated with these procedures are generally considered negligible. There are
no individual benefits of participation, besides the contribution to obtaining
scientific knowledge for the future.
's-Gravendijkwal 230
Rotterdam 3015CE
NL
's-Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
- Age of 18 years or older
AND
- Capable of understanding and signing informed consent
AND
- A diagnosis of HFpEF according to the HFA-PEFF diagnostic algorithm of the
ESC,
OR
- a high (90%) probability of HFpEF according to the H2FPEF score, i.e. a score
of 6 or higher
Exclusion criteria
-History of LVEF <=40%
-Scheduled for surgery or intervention for both coronary and non-coronary
indication within 6 months of inclusion
-Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 (CKD-EPI) or
requiring dialysis at the time of screening
-Acute or chronic liver disease, defined by serum levels of transaminases or
alkaline phosphatase more than three times the upper limit of normal at
screening
-COPD Gold stage IV
-Congenital heart disease
-Pregnancy
-Coexistent condition with life expectancy of <1 year
-Unlikely to appear at all scheduled follow-up visits
-Linguistic barrier
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 | NL80596.078.22 |