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Bio-impedance monitoring in patients hospitalized with acute decompensated heart failure


- candidate number22695
- NTR NumberNTR5356
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-aug-2015
- Secondary IDsB1260201523663 
- Public TitleBio-impedance monitoring in patients hospitalized with acute decompensated heart failure
- Scientific TitleAssessing the haemodynamic status, invasively and non-invasively, in patients hospitalized with acute decompensated heart failure (part II)
- ACRONYM
- hypothesisThe primary objective of this study is to explore the correlation between invasive and non-invasive haemodynamic variables and monitor the effect of treatment during admission for acute decompensated heart failure. In particular to investigate correlations between device data (trans-thoracic impedance) and invasive measures of pulmonary capillary wedge pressures.

The secondary objective is to investigate the relationship between device data at discharge and risk of readmission/death at 6 months.
- Healt Condition(s) or Problem(s) studiedHeart failure
- Inclusion criteria- Age ≥ 18 years
- Presence of an impedance-enabled CRT and/or ICD device > 2 months
- Hospitalized because of symptoms/ signs of decompensation
- Objective evidence of cardiac dysfunction
- NTproBNP on admission > 450 pg/ml
- Follow-up exclusively in the OLV Hospital of Aalst
- Need for treatment with diuretics (IV or oral), in higher dose than maintenance dose
- Exclusion criteria- Severe pulmonary disease (one minute forced expiratory volume below 1.0L/s)
- Poor echo window
- Anticoagulant therapy
- Need for ventilation
- Prisoners
- Pregnancy
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 10-jul-2015
- planned closingdate1-jul-2016
- Target number of participants20
- InterventionsN/A
- Primary outcomeThe ability of the device data to detect improvements in haemodynamic status.
- Secondary outcomePrognostic ability of the device data at discharge and 6-month re-admission or death.
- Timepoints
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD Riet Dierckx
- CONTACT for SCIENTIFIC QUERIESMD Riet Dierckx
- Sponsor/Initiator Philips Research Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Philips Research Eindhoven
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD11-aug-2015 - 25-aug-2015


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