Fluid status telemedicine alerts for heart failure: a randomized controlled trial
Key result
Fluid status telemedicine alerts fail to reduce death or CV hospitalization versus standard care.
- HR 0.87
- 95% CI 0.72-1.04
- P=0.13
- n=1,002
Why the study?
Does automated fluid status alert notification via telemedicine reduce the composite of all-cause death and cardiovascular hospitalization in ICD patients with advanced heart failure?
Population
1002 patients recently implanted with an implantable cardioverter defibrillator with or without cardiac…
Comparison
Automated fluid status alerts transmitted as… vs Standard care (no alerts).
Design
RCT, 1:1
Follow-up
average 1.9 years
Authors
Discussion
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Implication
Does not support routine fluid status alerts in advanced HF with ICDs; challenges benefit assumptions and leaves optimization questions open for future trials.
Study Design
Type
RCT (n=1,002)
Randomization
1:1
Structured PICO
Does automated fluid status alert notification via telemedicine reduce the composite of all-cause death and cardiovascular hospitalization in ICD patients with advanced heart failure?
P
Population
1002 patients recently implanted with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy, meeting one of three conditions: prior HF hospitalization, recent diuretic treatment, or recent brain natriuretic peptide increase.
I
Intervention
Automated fluid status alerts transmitted as inaudible text messages to the responsible physician, followed by a protocol-specified algorithm with remote review of device data and telephone contact to assess symptoms and initiate treatment.
C
Comparator
Standard care (no alerts).
O
Outcome
Composite of all-cause death and cardiovascular hospitalization.composite
Main Result
Effect estimate: HR 0.87 (95% CI 0.72-1.04)
Absolute Event Rate: 45% vs 48.1%
p-value: p=0.13
Automated fluid status telemedicine alerts did not significantly reduce the composite of all-cause death and cardiovascular hospitalization in ICD patients with advanced heart failure.
Limitations
- Adherence to treatment protocols by physicians and patients might be a challenge
- 24% of alerts were not transmitted and only 30% were followed by a medical intervention
- Adherence to treatment protocols by physicians and patients might be a challenge (24% of alerts not transmitted and 30% followed by a medical intervention)
Cite This Study
Böhm et al. (2016) conducted an RCT in Heart failure (n=1,002). Automated fluid status telemedicine alerts vs. Standard care (no alerts) was evaluated on Composite of all-cause death and cardiovascular hospitalization (HR 0.87, 95% CI 0.72-1.04, p=0.13). Fluid status telemedicine alerts did not significantly reduce all-cause death or cardiovascular hospitalization compared to standard care (HR 0.87; 95% CI 0.72-1.04; P=0.13).