Within this project we aim to determine the energetic conditions that underlie the transition to hypertrophy of the HOCM heart. A prospective comparison will be made between results of PET, MRI and function of cardiac myofilaments (in vitro). Also,…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation of energetic properties of the HOCM-heart (in vivo assessment with
PET and MRI) with it*s in vitro (myofilamental) efficiency of contraction.
Secondary outcome
- Comparison of energymetabolism (in vivo, in vitro) between HCM, aortic valve
stenosis and non-hypertrophic carriers.
- Histological determination of interstitial fibrosis and it*s relation to
septal (regional) contraction using CMR tagging.
- Peak strain values compared to contractile velocities of myofilaments.
- Relation between existence of myocardial disarray and the extent of
remodelling.
Background summary
Disturbed energetic homeostasis of the myocardium is thought to play a role in
the pathogenesis of HCM related hypertrophy.
Study objective
Within this project we aim to determine the energetic conditions that underlie
the transition to hypertrophy of the HOCM heart. A prospective comparison will
be made between results of PET, MRI and function of cardiac myofilaments (in
vitro).
Also, energetic myocardial homeostasis will be compared between HOCM patients
and patients with aortic valve stenosis (having concentric hypertrophy) and
carriers (without left ventricular hypertrophy), all selected for surgery
(except carriers), since we expect metabolic differences in HCM-related
hypertrophy, concentric hypertrophy and normal non- overloaded myocardium.
Study design
Study design: prospective, open, multicenter
Study burden and risks
Patients will undergo a echocardiography, PET/MRI- investigations and a
exercisetest in supine position for a maximum of 1,5 hour per investigation. To
minimize the burden of travelling, both procedures will be carried out on the
same day. For intravenous administration of the contrast-agent Gadolinium-DTPA
(Dotarem ©), a venflon will be inserted in the vena brachialis. Patients with
renal failure (glomerular filtration rate (GFR) < 30 ml/min) will be excluded
to avoid development of Gadolinium-DTPA induced nephrogenic systhemic fibrosis
(NSF). Obtainment of (single) LV septal biopsies in AVS-patients is regarded
safe, due to extensive experience of operators, clear visibility of the
interventricular septum after thoracotomy, and the small size of (single)
biopsies (2mm x 200µm x 0.15mm). As a result, the risk for conduction
abnormalities is negligible small. For comparison, obtainment of endomyocardial
biopsies during catheterisation has a low complication rate, while multiple
(larger) biopsies are taken without clear visibility
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
HOCM-patients scheduled for classic myectomy and eligible for CMR-and PET imaging. Indication for myectomy was based on a significant LV outflow tract (LVOT) pressure gradient >=30 mmHg at rest or provoked as documented by echocardiography and symptoms, despite optimal medical treatment.
Aortic valve stenosis patients selected to undergo valve surgery, according to the ESC-guidelines on the management of valvular heart disease.
Non-hypertrophic carriers (NHC) eligible for CMR- and PET imaging;Ref. Vahanian A et al. Guidelines on the management of valvular heart disease: The Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology. Eur Heart J. 2007 Jan;28(2):230-68. ;Protocol page 11-12
Exclusion criteria
Any absolute or relative contra-indication for CMR imaging (i.e. pacemaker and claustrophobia) or failure to give informed consent. Severely impaired renal function with a glomerular filtration rate (GFR) <30 ml/min.
Protocol page 11-12
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 | NL29526.029.09 |