Evaluate whether patients with elevated Lp(a) are characterized by increased active calcification of the aortic valve.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference between groups in 18F-NaF uptake in
the aortic valve, expressed as tissue-to-background ratio.
Secondary outcome
- To evaluate the in vitro calcification capacity of plasma Lp(a) from
participants
Background summary
Calcific aortic valve disease has a high unmet clinical need. Recent studies
demonstrate that elevated lipoprotein(a) (Lp(a)) is highly likely to be
causally related to aortic valve stenosis. 18F-NaF PET/CT imaging in patients
with aortic stenosis allows for non-invasive detection of active
microcalcification.
Study objective
Evaluate whether patients with elevated Lp(a) are characterized by increased
active calcification of the aortic valve.
Study design
Single center, cross-sectional study.
Study burden and risks
The results of this study contribute to the recognition of treatable risk
factors and development of imaging approaches to ultimately reduce morbidity
and mortality in aortic valve stenosis. Considering there are currently no
medical therapies to slow progression of aortic valve stenosis, there is a
clear medical need to recognize treatable risk factors and establish diagnostic
modalities which directly assess disease activity. With the advent of
Lp(a)-lowering therapies, we envision 18F-NaF imaging as a method to select
patients at risk and monitor therapeutic effects.
In the present study, participating subjects receive no direct or immediate
benefits. The burden and risk of participating in this study is estimated to be
low. Patients will visit the clinical trial unit at least once for PET/CT
imaging procedures (90 minutes). Depending on whether prior Lp(a) levels and
echocardiograms are available another screening visit may be needed (60 min).
There are no direct adverse effects associated with PET/CT scanning. The
maximum exposure related to PET/CT scanning is 9.9 mSv in this study. However,
patients included in this study have aortic valve stenosis and while
progression rates may vary between patients, progression to severe stenosis
and/or symptomatic stenosis is associated with a low event-free survival rate.
The potential benefits of establishing novel treatable risk factors for aortic
valve stenosis is expected to compensate for the radiation risk. In addition,
this study is relevant for a much larger group of aortic valve stenosis
patients, who will not have to be exposed to these risks due to this study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Adult patients, aged 45-80 years old
- Mild to moderate aortic valve stenosis: on echocardiography, aortic valve maximum velocity is >2.0 m/sec
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Severe aortic valve stenosis
- History of radiotherapy of the thorax
- History of rheumatic fever
- Renal insufficiency, defined as eGFR < 30 ml/min
- Hyperparathyroidism
- Paget*s disease of the bone
- Any other treatment or clininically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
- Standard contra-indications to PET/CT
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 | NL62677.018.17 |