CHAMPION trial
A trial in US adults with NYHA class III heart failure and a past hospital stay for heart failure. The registry results describe 550 implanted patients, and the registry says the sensor is implanted in the pulmonary artery. Clinicians used daily pressure readings from it to adjust care in the treatment group; the control group had standard care. Over 6 months, the treatment group had fewer hospital admissions for heart failure. Only the patients, not the clinicians, were masked to the assignment.
Also called CHAMPION · CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
- Study
- In this atlas
Overview
- Design
- Randomized, parallel-group, single-blind trial of heart-failure management guided by an implanted wireless pulmonary artery pressure sensor, against standard care. The registry records masking as single and the phase as not applicable. Only patients were masked.
- Phase
- Not applicable
- Enrolled
- 550 participants
- Sponsor
- Not recorded
- Funder
- Not recorded
- Registry
-
NCT00531661
-
- Started
- Primary completion
- (actual)
- Completion
- (actual)
- Results first posted
- Countries
- United States
- Care setting
- Not reported
- Registry status
- “COMPLETED”
Technical summary
Industry-sponsored randomized single-blind trial (NCT00531661; the registry lead sponsor is CardioMEMS) of a wireless implantable hemodynamic monitoring system, the device that FDA approved under PMA P100045. The Lancet abstract reports 83 heart-failure-related hospitalisations in the treatment group (270 people) against 120 in the control group (280 people) at 6 months, hazard ratio 0.70 (95% CI 0.60 to 0.84). PubMed links an erratum (Lancet 2012;379:412) that was not read. The registry count of 550 is the registry's actual enrollment; the abstract gives the two group sizes (270 and 280) for the 6-month analysis. The full text was not read. The abstract names CardioMEMS as the funder.
Arms
-
Treatment group
Intervention CardioMEMS HF System
Standard heart-failure care plus management based on pulmonary artery pressure readings from the implanted sensor system (registry and abstract). Only patients were masked to assignment.
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Control group
Intervention
Standard heart-failure care alone (registry and abstract).
Findings
No findings are published for this study.
Record details
- Record id
cardio:champion-trial- Content hash
e76d3277dbee57b6398da41ced4104bb2afb6dcc4cd7075cfffdddbd21f7d3f9