To assess the risk profile associated with the combined endpoint of all-cause mortality and HF hospitalizations in HF patients with LVEF >0.40.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of the combined endpoint of all-cause mortality and heart faillure
hospitalizations.
Secondary outcome
1. To assess the risk profile associated with incident atrial fibrillation (AF)
in patients without baseline or history of AF.
2. To assess the risk profile associated with HF hospitalizations, all-cause
mortality, cardiovascular mortality and sudden death separately.
3. To assess the risk profile associated with cardiac amyloid deposition.
Background summary
Heart failure (HF) with a left ventricular ejection fraction (LVEF) >0.40 is a
large medical problem, for which no drug or device has a recommendation in
current HF guidelines. The prevalence of mortality and HF hospitalizations in
HF with LVEF >0.40 is high, but the identification of predictors for increased
risk of mortality and HF hospitalizations in this patient category remains
difficult. The hypothesis of this study is that the risk of all-cause mortality
and HF hospitalizations can be measured by clinical factors, imaging parameters
and circulating biomarkers, and that these factors can be used in a risk
profile.
Study objective
To assess the risk profile associated with the combined endpoint of all-cause
mortality and HF hospitalizations in HF patients with LVEF >0.40.
Study design
Single-center, prospective, non-randomized, observational study. Total duration
is 5 years.
Study burden and risks
The present study may render important insights into the incidence of all-cause
mortality and heart failure hospitalizations in patients with HFpEF.
Eventually, this may lead to improved risk stratification, therapeutic choices
and hence patient-tailored therapy. At present no drug or device therapy has
been proven beneficial in patients with HFpEF. Blood sampling occurs during
vena punctures performed for usual care. Risks of a vena puncture are very
slight and include excessive bleeding, fainting or feeling light-headed,
hematoma, local infection. Obtaining a blood sample from some people may be
more difficult than from others. The usage of positron emitting isotopes in the
99m technetium scan translates to an exposure to ionizing radiation. Because of
the potential hazards of radiation exposure, guidelines for the exposure of
healthy volunteers are laid down in *Besluit stralingsbescherming, artikel 60,
staatblad 2001, 397* in accordance with the guidelines of the International
Commission on Radiological Protection (ICRP). The radiation dose of 99mTc-HDP
is 0.0057 mSv/MBq for adults. Patients will receive a total dose of 500 MBq IV,
which translates to a total radiation dose of ± 2.9 mSv for the 99mTc-HDP scan.
The radiation of a low dose CT is approximately 0.5 mSv, which totals to a dose
of 3.4 mSv combined with the 99mTc-HDP scan. This complies with category IIb,
ICRP 62. The radation dose is calculated by our local clinical physicist. There
are no other study-related procedures required. There are no other
study-related procedures required.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Clinical criteria: 1. Age >18 years 2. Written informed consent 3. HF with
moderate to severe symptoms NYHA II or III 4. Hospitalization or emergency room
visit for HF or symptom relief with diuretics 5. Sinus rhythm or AF,
Echocardiographic criteria: 1. LVEF >40% 2. Left atrial size (volume >=29 mL/m2
or LA parasternal diameter >=45 or left ventricular hypertrophy (septal
thickness or posterior wall thickness >=11 mm) of left ventricular diastolic
dysfunction (E/e* >=13 or mean e* septal and lateral wall <9 cm/s)., Biomarker
criteria: 1. BNP >31ng/L or NT-pro-BNP>125ng/L if sinus rhythm 2. BNP >75ng/L
or NT-pro-BNP>300ng/L if atrial fibrillation
Exclusion criteria
1. Patients unwilling or unable to sign informed consent 2. Patients with a
pacemaker or ICD 3. Indication for ICD therapy according to the European
Society of Cardiology (ESC) guidelines 4. Life expectancy of less than one year
5. Significant coronary artery disease or myocardial infarction < 3 months 6.
Complex congenital heart disease 7. Pregnancy
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 |
|---|---|
| ClinicalTrials.gov | NCT01989299 |
| CCMO | NL75981.042.21 |