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Home or Hospital Heart Failure - HHH
Description:
The goal of the trial was to evaluate telemonitoring of respiration and vital signs compared with control among patients with stable heart failure (HF).
Study Design
Patients Screened: 3,036
Patients Enrolled: 461
Mean Follow Up: One year
Mean Patient Age: Mean age 60 years
Female: 15
Patient Populations:
Age >18 years with clinical history of HF; NYHA class II-IV; LVEF ≤40%; etiology ischemic, idiopathic, hypertensive, or valvular; ≥ one HF hospitalization in the prior 12 months; abnormal echo diastolic pattern; and optimal medical therapy
Exclusions:
Age >80 years; other forms of cardiomyopathy; myocardial infarction, percutaneous transluminal coronary angioplasty, or bypass surgery in the prior 6 months; ventricular pacemaker stimulation; chronic renal insufficiency; or poor compliance in the management of the telemonitoring system
Primary Endpoints:
Hospitalization due to HF
Secondary Endpoints:
Composite of cardiac death or hospitalization due to HF; all-cause mortality; prevalence of breathing abnormalities
Drug/Procedures Used:
Patients were randomized 2:1 to telemonitoring (n = 301) or control (n = 160). In the telemonitoring group, respiration and vital signs were recorded and transmitted via a telephone line. Within the telemonitoring group, randomization was further divided into three groups: 1) answering machine plus nurse telephone contact (n = 106); 2) addition of weekly vital signals (n = 94); and 3) addition of weekly vital signals and ECG respiration position (n = 101). All patients were treated with usual care.
Principal Findings:
Patients were enrolled in Italy (46%), Poland (41%), and the United Kingdom (13%). Vital sign transmission was completed in 81% of transmissions and respiratory transmission was complete in 92%. HF etiology was ischemic in the majority of patients (56%). New York Heart Association (NYHA) class ≥3 was present in 40% of patients and mean left ventricular ejection fraction (LVEF) was 29%.
There was no difference in the primary endpoint of hospitalizations due to HF by 12 months between the groups (16.9% with telemonitoring vs. 16.3% with control, p = 0.97). There was also no difference in all-cause mortality between the treatment groups or the composite of hospitalization due to HF or mortality (20.6% vs. 18.8%, p = NS).
Patients with apnea/hypopnea index ≥15 events per hour had a significantly higher cardiac death rate compared with those with an index <15 events per hour (p = 0.0006).
Interpretation:
Among patients with stable HF, telemonitoring of respiration and vital signs was feasible, but was not associated with a difference in the primary endpoint of HF hospitalizations compared with the usual care control group.
In addition to a lack efficacy in the primary endpoint, there was also no difference between groups in the secondary endpoints of mortality or the composite of death or HF hospitalization. Although use of the telemonitoring device appeared feasible and had a high rate of successful transmissions (>80%), it should be noted that patients with poor compliance in the management of the telemonitoring system were excluded from the trial.
Given the lack of efficacy and the presumably higher costs associated with the device, the clinical applicability of the device is unclear at this time, although it is possible that integration of the device into patient management, which was not done in the present study, could be useful. An additional finding of the study was the high mortality rate in HF patients with severe sleep apnea.
References:
Presented by A. Mortara, European Society of Cardiology Scientific Congress, September 2006.
Mortara A, Pinna GD, Johnson P, et al. Home telemonitoring in heart failure patients: the HHH study (Home or Hospital in Heart Failure). Eur J Heart Fail. 2009 Mar;11(3):312-8.
Keywords: Telephone, Heart Failure, Stroke Volume, Electrocardiography, Hospitalization, Sleep Apnea Syndromes
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