Primary Objectives: - To investigate whether disease progression in individual patients with CHF can be accurately assessed by serial measurements of disease-related (novel) biomarkers.- To investigate whether dynamic biomarker patterns as…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the composite of cardiovascular death, cardiac
transplantation, left ventricular assist device implantation, and
re-hospitalization for the management of acute or worsened heart failure.
Secondary outcome
Secondary endpoints include:
- The individual components of the primary endpoint, i.e. cardiovascular death,
cardiac transplantation, left ventricular assist device implantation and
re-hospitalization for acute or worsened heart failure
- 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)
- All-cause mortality
Background summary
Diagnosis of decompensation in patients with chronic heart failure (CHF) and
initiation of additional treatment is currently only possible when symptoms
have become manifest. Consequently, treatment also can only start at this
stage. As such, there is an urgent need for reliable non-invasive measures of
pre-symptomatic decline of cardiac function.
HF results from a complex interplay among neurohormonal, inflammatory and
biochemical changes. Biomarkers have the potential to monitor subtle changes in
the heart that reflect and possibly predict adverse changes before they become
clinically apparent. Use of serial biomarker measurements (as opposed to a
single measurement at baseline) may provide information on individual patterns
of change and may therefore contribute to personalized medicine. In the current
study we will investigate whether such serial biomarker measurements can be
used to improve prognostication in chronic heart failure patients.
As a substudy, we will investigate whether 2 new echocardiographic techniques
improve prognostication in chronic heart failure patients. Until now, the
state-of-the-art echocardiographic technique used in chronic heart failure
patients in Tissue Doppler. However, this technique has limitations such as the
poor signal-to-noise ratio, and therefore, new alternatives are needed. In th
current study, we will investigate which echocardiographic technique is best
suited to visualize cardiac function and we will correlate the prognostic value
of the echocardiographic techniques with serial biomarker measurements.
Should the serial biomarker measurements and the new echocardiographic
techniques prove to be useful in prognostication, then this would contribute to
individualized medicine in patients with heart failure. Treatment would become
possible at an earlier stage and the progression and the effect of treatment
could be monitored more closely. This could contribute to improved clinical
outcomes and improved quality of life in patients with heart failure.
Study objective
Primary Objectives:
- To investigate whether disease progression in individual patients with CHF
can be accurately assessed by serial measurements of disease-related (novel)
biomarkers.
- To investigate whether dynamic biomarker patterns as determined during serial
measurements provide additional prognostic value in individual patients with
CHF when compared to the static risk models that include a single biomarker
measurement at baseline. In other words, to examine how the initial assessment
of prognosis is influenced by the results of repeated biomarker measurements
over a longer period of time.
- To compare serial biomarker patterns in chronic HF patients with diminished
and normal ejection fraction and thereby further elucidate etiologic
mechanisms.
Objectives of the echocardiographic substudy:
- To compare Speckle tracking with TDI in CHF patients; relate measurements by
Speckle tracking and TDI to cardiovascular outcome
- To assess the feasibility of applying 3D-echocardiography in a CHF
population; compare 2D- with real-time 3D-echocardiography in CHF patients;
relate measurements by 2D- and 3D-echocardiography to outcome
- To correlate serial echocardiographic measurements with serial biomarker
values.
Study design
This is a prospective, observational, multi-center, cohort study.
Study burden and risks
The main burden of this study consists of extra visits to the outpatient clinic
(twice per year) and of extra venipunctures (a total of 5 times) during a
maximum period of 30 months.
's Gravendijkwal 230 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
1. Men and women, aged 18 years or older, capable of understanding and signing informed consent
2. Diagnosis of chronic heart failure, systolic and diastolic, according to the guidelines of the European Society of Cardiology (ESC)
Exclusion criteria
1. Heart failure secondary to circulatory high output conditions
2. Scheduled for surgery or intervention for both coronary and non-coronary indication within 6 months of inclusion
3. Severe renal failure for which dialysis is needed
4. Coexistent condition with life expectancy * 1 year
5. Unlikely to appear at all scheduled follow-up visits
6. Known moderate or severe liver disease
7. COPD Gold stage IV
8. Congenital heart disease
9. 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 | NL34532.078.10 |