BACKGROUND: Meta-analyses have suggested that remote telemedical management (RTM) positively affects clinical outcomes in chronic HF patients. The results of two recent randomised RTM trials do not corroborate these results. We aim to report prospectively defined and exploratory subgroup analyses for the TIM-HF trial and to identify a patient profile that could potentially benefit from RTM for further investigation in randomised clinical trials. METHODS: In TIM-HF, 710 stable chronic HF patients, in NYHA class II or III with a history of HF decompensation within 2 years previously or a LVEF ≤ 25% were randomly assigned (1:1) to RTM or usual care. The primary outcome was total death and secondary outcomes included days lost due to death or HF hospitalisation and a composite of cardiovascular death and HF hospitalisation. Twelve subgroups were prospectively defined and patient profiling was investigated for the subgroup with a prior history of HF decompensation, an LVEF ≥ 25% and a PHQ-9 score<10. RESULTS: The subgroup treatment effects were significant for total mortality for the PHQ-9 subgroup only (p for interaction<0.027). For the outcome 'number of days lost due to hospitalisation for HF or death', the subgroup treatment effects were significant (p for interaction<0.05) for patients with a prior HF decompensation or an ICD implant or a PHQ score of <10 and for the patient-profiling subgroup. CONCLUSIONS:Telemedicine management may not be appropriate for all HF patients. Future research needs to investigate which HF population may benefit from this intervention.
RCT Entities:
BACKGROUND: Meta-analyses have suggested that remote telemedical management (RTM) positively affects clinical outcomes in chronic HF patients. The results of two recent randomised RTM trials do not corroborate these results. We aim to report prospectively defined and exploratory subgroup analyses for the TIM-HF trial and to identify a patient profile that could potentially benefit from RTM for further investigation in randomised clinical trials. METHODS: In TIM-HF, 710 stable chronic HF patients, in NYHA class II or III with a history of HF decompensation within 2 years previously or a LVEF ≤ 25% were randomly assigned (1:1) to RTM or usual care. The primary outcome was total death and secondary outcomes included days lost due to death or HF hospitalisation and a composite of cardiovascular death and HF hospitalisation. Twelve subgroups were prospectively defined and patient profiling was investigated for the subgroup with a prior history of HF decompensation, an LVEF ≥ 25% and a PHQ-9 score<10. RESULTS: The subgroup treatment effects were significant for total mortality for the PHQ-9 subgroup only (p for interaction<0.027). For the outcome 'number of days lost due to hospitalisation for HF or death', the subgroup treatment effects were significant (p for interaction<0.05) for patients with a prior HF decompensation or an ICD implant or a PHQ score of <10 and for the patient-profiling subgroup. CONCLUSIONS: Telemedicine management may not be appropriate for all HF patients. Future research needs to investigate which HF population may benefit from this intervention.
Authors: Mateusz Tajstra; Adam Sokal; Arkadiusz Gwóźdź; Marcin Wilczek; Adam Gacek; Konrad Wojciechowski; Elżbieta Gadula-Gacek; Elżbieta Adamowicz-Czoch; Katarzyna Chłosta-Niepiekło; Krzysztof Milewski; Piotr Rozentryt; Zbigniew Kalarus; Mariusz Gąsior; Lech Poloński Journal: Ann Noninvasive Electrocardiol Date: 2016-12-25 Impact factor: 1.468
Authors: Natalie M Jayaram; Yevgeniy Khariton; Harlan M Krumholz; Sarwat I Chaudhry; Jennifer Mattera; Fengming Tang; Jeph Herrin; Beth Hodshon; John A Spertus Journal: Circ Cardiovasc Qual Outcomes Date: 2017-12
Authors: Nils Reiss; Thomas Schmidt; Michael Boeckelmann; Sebastian Schulte-Eistrup; Jan-Dirk Hoffmann; Christina Feldmann; Jan D Schmitto Journal: J Thorac Dis Date: 2018-06 Impact factor: 2.895