To investigate the prevalence of transthyretin amyloid cardiomyopathy in HFpEF patients with a cardiac implantable electronic device (CIED) such as a pacemaker or Implantable Cardioverter Defibrillator (ICD)
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The prevalence of ATTR, measured by bone scintigraphy, in HFpEF patients with
CIED.
Secondary outcome
A) To assess the frequency of (re-)hospitalization of HFpEF patients with a
CIED diagnosed with or without transthyretin amyloid cardiomyopathy.
B) To assess the clinical characteristics of HFpEF patients also diagnosed with
transthyretin amyloid cardiomyopathy.
C) To assess the clinical characteristics of HFpEF patients that decrease the
likelihood of the presence of transthyretin amyloid cardiomyopathy.
D) To assess the mortality of HFpEF patients with a CIED diagnosed with or
without transthyretin amyloid cardiomyopathy.
Background summary
Transthyretin-derived amyloidosis (ATTR) is a specific cause of heart failure
with preserved ejection fraction (HFpEF). The impact of ATTR on HFpEF leads to
poorer prognosis. Therefore, screening for ATTR amyloidosis in HFpEF is
meaningful. However, the HFpEF population is heterogeneous and the prevalence
of ATTR in HFpEF is not definitive established. The prevalence of ATTR in
specific HFpEF subgroups may be higher than the overall prevalence of 13%. As
heart failure symptoms and advanced conduction disturbances are often observed
in ATTR patients, we hypothesise that the prevalence of ATTR in HFpEF patients
with conduction disturbances for which pacemaker implantation was needed, is
higher than the general HFpEF population.
Study objective
To investigate the prevalence of transthyretin amyloid cardiomyopathy in HFpEF
patients with a cardiac implantable electronic device (CIED) such as a
pacemaker or Implantable Cardioverter Defibrillator (ICD)
Study design
Single centre, prospective, observational study.
Study burden and risks
In bone scintigraphy the tracer 99mTc-HDP is used. It is a minimally invasive
procedure, as only the tracer needs to be administered intravenously. A small
possibility of an allergic reaction to the tracer is possible. The expected
radiation dose from the entire procedure is 4.5 mSv per scan. There is no risk
for other people that come in contact with the patient after the scan.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
Heart failure, NYHA 2 or 3.
CIED
LVEF > 40%
NT-proBNP >400 ng/L sinus rhythm; > 1200 ng/L atrial fibrillation
Exclusion criteria
Unwilling or unable to sign informed consent.
Life expectancy < 1 year.
Signficant coronary artery disease or myocardial infarction < 3 months
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 | NL72578.042.20 |