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ID
Source
Brief title
Health condition
Heart Failure, Pulmonary hypertension, right-heart catheterization, echocardiography, MRI, hartfalen, pulmonale hypertensie, rechts kathterisatie, echocardiografie
Sponsors and support
CVON (Cardiovasculair Onderzoek Nederland)
Intervention
Outcome measures
Primary outcome
Our primary endpoint will be the differences and the correlation between pressures in mmHg measured during right heart catheterization, and MRI measurements of venous congestion parameters (flow pattern and dimension changes of vena cava superior).
Secondary outcome
i. The differences and the correlation between pressures in mmHg, measured during right heart catheterization and echocardiographic measurements of CVP (vena cava inferior). Additionally, echocardiographic measurement of vena jugularis interna flow will be included.
ii. The differences and the correlation between measurements of echocardiography and MRI.
iii. Correlation between NT-proBNP and right-sided intra-cardiac pressures
Background summary
Venous congestion due to elevated central venous pressure (CVP) contributes to impaired organ function. In fact, it may be even more important than arterial hypoperfusion as it impedes drainage of blood flow, resulting in accumulation of deoxygenated blood, causing cell damage and increased fibrosis, as shown for kidney and liver function(1-3) . It is, however, completely unknown if this also applies to the brain. Still, it has recently been shown that venous abnormalities are related to structural brain changes seen in cerebral small vessel disease (SVD). Jugular vein reflux measured by Duplex, which is related to CVP (4) might be related to white matter changes(5) and to increased intracranial pressure(6). Therefore, we hypothesize that elevated CVP and venous congestion might be related to structural and functional abnormalities of the brain independently of cardiac output. By analyzing the MRI data from the Heart -Brain Connection study (multicenter CVON research), we have the unique opportunity to address this clinically highly relevant question. However, assessment of CVP and venous congestion by MRI has not yet been validated.
Study objective
We hypothesize that MRI measurements of flow and structure of superior vena cava is capable to estimate venous congestion with sufficient accuracy.
Study design
One visit only.
Intervention
Not applicable
Inclusion criteria
1. Adult patients (i.e. >18 years of age)
2. Receiving right-heart catheterization for a clinical indication
Exclusion criteria
1. Contra-indication for MRI or unable to undergo MRI protocol due to physical condition
- Current atrial fibrillation/atrial flutter
- Current premature ventricular contractions (PVCs) exceeding 10% of total number of heartbeats, e.g. a heart rate of 60/min and >6 PVCs
- BMI > 40.0 kg/m2 or body habitus not suited for undergoing MRI
- Claustrophobic patients
- Implanted device (i.e. pacemaker, loop recorder, implantable cardiac defibrillator, neurostimulator)
- Magnetic metals in the body that do not allow MRI
2. Participation in ongoing trials for therapeutic interventions including randomized controlled trials and clinical trials of investigational medicinal products
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7086 |
| NTR-old | NTR7284 |
| CCMO | NL66255.068.18 |
| OMON | NL-OMON46220 |