Effect Modification of Remote Patient Management by Sex and Marital Status Among Patients With Heart Failure in Germany: Findings From the Extended Interdisciplinary Network Heart Failure Trial.

BACKGROUND

Previous randomized trials of different remote patient management (RPM) strategies have yielded heterogeneous results in heart failure (HF) populations. It remains unclear whether the effects of RPM are modulated by patient sex and marital status.

METHODS

We conducted a secondary analysis of the multicenter, randomized E-INH study (Extended Interdisciplinary Network Heart Failure), which enrolled patients hospitalized with acute systolic HF and a left ventricular ejection fraction ≤40% between 2004 and 2007. Participants were assigned in a 1:1 ratio to receive a telephone-based, nurse-coordinated multidisciplinary RPM strategy (HeartNetCare-HF) plus usual care or usual care alone for 18 months, followed by 42 months of intervention-free follow-up. Patients with available marital status information were included in the present analysis. Flexible parametric Royston-Parmar survival models were used to assess interactions between RPM, sex, and marital status for all-cause death, HF hospitalization, and the composite end point at 18 and 60 months.

RESULTS

Of the 1022 randomized participants, 1008 provided information on marital status (mean age, 68±13 years; 28% were women, and 63% were married). Sex and marital status modified the effect of RPM on all-cause death, with a significant 3-way interaction at 18 (P=0.015) and 60 (P=0.004) months. At 60 months, all-cause mortality ranged from 28% among married women receiving RPM to almost 60% among unmarried men receiving usual care. The greatest impact of RPM versus usual care on all-cause death was observed among married women: adjusted hazard ratios were 0.32 (95% CI, 0.10-0.98) and 0.44 (0.22-0.88) at 18 and 60 months, respectively.

CONCLUSIONS

These findings indicate that the benefits from the RPM strategy HeartNetCare-HF in patients discharged after hospitalization for acute systolic HF were modulated by sex and marital status, both individually and in combination. Future studies are needed to evaluate whether tailoring RPM interventions according to patient sex and marital status optimizes outcomes in patients with HF.