October 18, 2010European Journal of Heart Failure
Assessment of a Novel Device-Based Diagnostic Algorithm to Monitor Patient Status in Moderate-To-Severe Heart Failure: Rationale and Design of the CLEPSYDRA Study
Why the study?
Does the physiological diagnostic (PhD) algorithm accurately detect heart failure events in patients with moderate-to-severe heart failure?
Population
Patients with moderate-to-severe heart failure, on stable optimal pharmacological therapy, QRS ≥120 ms, and…
Design
Cohort, non-randomized, double-blinded
Follow-up
minimum of 13 months
Authors
Discussion
Loading...
Member takes
Implication
The CLEPSYDRA study is designed to evaluate the sensitivity of a novel device-based diagnostic algorithm (PhD) for detecting worsening heart failure events in patients with moderate-to-severe heart failure.
Structured PICO
Does the physiological diagnostic (PhD) algorithm accurately detect heart failure events in patients with moderate-to-severe heart failure?
P
Population
Patients with moderate-to-severe heart failure, on stable optimal pharmacological therapy, QRS ≥120 ms, and ejection fraction ≤0.35%. 214 patients enrolled at time of submission.
I
Intervention
Physiological diagnostic (PhD) algorithm combining data from minute ventilation and accelerometer sensors integrated into electronic implantable devices
O
Outcome
Sensitivity of the PhD (proportion of HF-related clinical events occurring within a 4-week period after a PhD HF indication)surrogate
The CLEPSYDRA study is designed to evaluate the sensitivity of a novel device-based diagnostic algorithm (PhD) for detecting worsening heart failure events in patients with moderate-to-severe heart failure.
Cite This Study
Auricchio et al. (2010) studied this question.