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Venous Congestion Validation study

Venous Congestion Validation study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22315
Enrollment
30
Registered
2018-06-08
Start date
2018-07-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Pulmonary hypertension, right-heart catheterization, echocardiography, MRI, hartfalen, pulmonale hypertensie, rechts kathterisatie, echocardiografie

Interventions

None listed

Sponsors

MUMC+
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients (i.e. >18 years of age) 2. Receiving right-heart catheterization for a clinical indication

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Contacts

Public ContactNGHM Marcks
nick.marcks@mumc.nl043-3875102

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)