Browsing by Author "Winkler, Sebastian"
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- ItemEfficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial.(0000-00-00) Koehler, Friedrich; Koehler, Kerstin; Deckwart, Oliver; Prescher, Sandra; Wegscheider, Karl; Kirwan, Bridget-Anne; Winkler, Sebastian; Vettorazzi, Eik; Bruch, Leonhard; Oeff, Michael; Zugck, Christian; Doerr, Gesine; Naegele, Herbert; Störk, Stefan; Butter, Christian; Sechtem, Udo; Angermann, Christiane; Gola, Guntram; Prondzinsky, Roland; Edelmann, Frank; Spethmann, Sebastian; Schellong, Sebastian M; Schulze, P Christian; Bauersachs, Johann; Wellge, Brunhilde; Schoebel, Christoph; Tajsic, Milos; Dreger, Henryk; Anker, Stefan D; Stangl, KarlBACKGROUND Remote patient management in patients with heart failure might help to detect early signs and symptoms of cardiac decompensation thus enabling a prompt initiation of the appropriate treatment and care before a full manifestation of a heart failure decompensation We aimed to investigate the efficacy of our remote patient management intervention on mortality and morbidity in a well defined heart failure population METHODS The Telemedical Interventional Management in Heart Failure II TIM HF2 trial was a prospective randomised controlled parallel group unmasked with randomisation concealment multicentre trial with pragmatic elements introduced for data collection The trial was done in Germany and patients were recruited from hospitals and cardiology practices Eligible patients had heart failure were in New York Heart Association class II or III had been admitted to hospital for heart failure within 12 months before randomisation and had a left ventricular ejection fraction LVEF of 45 or lower or if higher than 45 oral diuretics were being prescribed Patients with major depression were excluded Patients were randomly assigned 1 1 using a secure web based system to either remote patient management plus usual care or to usual care only and were followed up for a maximum of 393 days The primary outcome was percentage of days lost due to unplanned cardiovascular hospital admissions or all cause death analysed in the full analysis set Key secondary outcomes were all cause and cardiovascular mortality This study is registered with ClinicalTrials gov number NCT01878630 and has now been completed FINDINGS Between Aug 13 2013 and May 12 2017 1571 patients were randomly assigned to remote patient management n 796 or usual care n 775 Of these 1571 patients 765 in the remote patient management group and 773 in the usual care group started their assigned care and were included in the full analysis set The percentage of days lost due to unplanned cardiovascular hospital admissions and all cause death was 4 88 95 CI 4 55 5 23 in the remote patient management group and 6 64 6 19 7 13 in the usual care group ratio 0 80 95 CI 0 65 1 00 p 0 0460 Patients assigned to remote patient management lost a mean of 17 8 days 95 CI 16 6 19 1 per year compared with 24 2 days 22 6 26 0 per year for patients assigned to usual care The all cause death rate was 7 86 95 CI 6 14 10 10 per 100 person years of follow up in the remote patient management group compared with 11 34 9 21 13 95 per 100 person years of follow up in the usual care group hazard ratio HR 0 70 95 CI 0 50 0 96 p 0 0280 Cardiovascular mortality was not significantly different between the two groups HR 0 671 95 CI 0 45 1 01 p 0 0560 INTERPRETATION The TIM HF2 trial suggests that a structured remote patient management intervention when used in a well defined heart failure population could reduce the percentage of days lost due to unplanned cardiovascular hospital admissions and all cause mortality FUNDING German Federal Ministry of Education and Research
- ItemImpact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study.(2011-05-03) Koehler, Friedrich; Winkler, Sebastian; Schieber, Michael; Sechtem, Udo; Stangl, Karl; Böhm, Michael; Boll, Herbert; Baumann, Gert; Honold, Marcus; Koehler, Kerstin; Gelbrich, Goetz; Kirwan, Bridget-Anne; Anker, Stefan D; ,BACKGROUND This study was designed to determine whether physician led remote telemedical management RTM compared with usual care would result in reduced mortality in ambulatory patients with chronic heart failure HF METHODS AND RESULTS We enrolled 710 stable chronic HF patients in New York Heart Association functional class II or III with a left ventricular ejection fraction 35 and a history of HF decompensation within the previous 2 years or with a left ventricular ejection fraction 25 Patients were randomly assigned 1 1 to RTM or usual care Remote telemedical management used portable devices for ECG blood pressure and body weight measurements connected to a personal digital assistant that sent automated encrypted transmission via cell phones to the telemedical centers The primary end point was death from any cause The first secondary end point was a composite of cardiovascular death and hospitalization for HF Baseline characteristics were similar between the RTM n 354 and control n 356 groups Of the patients assigned to RTM 287 81 were at least 70 compliant with daily data transfers and no break for 30 days except during hospitalizations The median follow up was 26 months minimum 12 and was 99 9 complete Compared with usual care RTM had no significant effect on all cause mortality hazard ratio 0 97 95 confidence interval 0 67 to 1 41 P 0 87 or on cardiovascular death or HF hospitalization hazard ratio 0 89 95 confidence interval 0 67 to 1 19 P 0 44 CONCLUSIONS In ambulatory patients with chronic HF RTM compared with usual care was not associated with a reduction in all cause mortality CLINICAL TRIAL REGISTRATION URL http www ClinicalTrials gov Unique identifier NCT00543881
- ItemA new telemonitoring system intended for chronic heart failure patients using mobile telephone technology--feasibility study.(2011-11-14) Winkler, Sebastian; Schieber, Michael; Lücke, Stephanie; Heinze, Peter; Schweizer, Thomas; Wegertseder, Dominik; Scherf, Michael; Nettlau, Herbert; Henke, Sascha; Braecklein, Martin; Anker, Stefan D; Koehler, FriedrichBACKGROUND Remote monitoring is one modality of structured care in chronic heart failure The purpose of this study was to evaluate the feasibility of a new wireless telemonitoring system via a mobile phone network METHODS Portable home devices for electrocardiogram blood pressure body weight and self assessment measurements were connected via Bluetooth to a personal digital assistant PDA that performs automated encrypted transmission via mobile phone Two telemedical centres were set up RESULTS 30 healthy volunteers were enrolled and followed for 26 days A total of 4002 single measurements were taken 133 37 per person No data was lost or incorrectly allocated 880 of 937 94 of the ECG recordings had sufficient diagnostic quality for rhythm analysis and single beat measurements 50 continuous ECG streams 312 min without disruption were performed Total system availability was 96 6 including that of the mobile phone network CONCLUSIONS Mobile phone technology is suitable for continuous and secure medical data transmission To evaluate the clinical use in chronic heart failure patients a large multicentre randomized controlled trial ClinicalTrials gov Identifier NCT00543881 was started
- ItemTele-accelerometry as a novel technique for assessing functional status in patients with heart failure: feasibility, reliability and patient safety.(2013-10-25) Jehn, Melissa; Prescher, Sandra; Koehler, Kerstin; von Haehling, Stephan; Winkler, Sebastian; Deckwart, Oliver; Honold, Marcus; Sechtem, Udo; Baumann, Gert; Halle, Martin; Anker, Stefan D; Koehler, FriedrichThe six minute walk test 6MWT is an established measure of functional exercise capacity associated with clinical prognosis in Chronic Heart Failure CHF The aim of this study is to evaluate the employment of tele accelerometry for the remote assessment of 6MWT in CHF
- ItemTelemedical Interventional Management in Heart Failure II (TIM-HF2), a randomised, controlled trial investigating the impact of telemedicine on unplanned cardiovascular hospitalisations and mortality in...(0000-00-00) Koehler, Friedrich; Koehler, Kerstin; Deckwart, Oliver; Prescher, Sandra; Wegscheider, Karl; Winkler, Sebastian; Vettorazzi, Eik; Polze, Andreas; Stangl, Karl; Hartmann, Oliver; Marx, Almuth; Neuhaus, Petra; Scherf, Michael; Kirwan, Bridget-Anne; Anker, Stefan DBACKGROUND Heart failure HF is a complex chronic condition that is associated with debilitating symptoms all of which necessitate close follow up by health care providers Lack of disease monitoring may result in increased mortality and more frequent hospital readmissions for decompensated HF Remote patient management RPM in this patient population may help to detect early signs and symptoms of cardiac decompensation thus enabling a prompt initiation of the appropriate treatment and care before a manifestation of HF decompensation OBJECTIVE The objective of the present article is to describe the design of a new trial investigating the impact of RPM on unplanned cardiovascular hospitalisations and mortality in HF patients METHODS The TIM HF2 trial is designed as a prospective randomised controlled parallel group open with randomisation concealment multicentre trial with pragmatic elements introduced for data collection Eligible patients with HF are randomised 1 1 to either RPM usual care or to usual care only and are followed for 12 months The primary outcome is the percentage of days lost due to unplanned cardiovascular hospitalisations or all cause death The main secondary outcomes are all cause and cardiovascular mortality CONCLUSION The TIM HF2 trial will provide important prospective data on the potential beneficial effect of telemedical monitoring and RPM on unplanned cardiovascular hospitalisations and mortality in HF patients TRIAL REGISTRATION ClinicalTrials gov Identifier NCT01878630
- ItemTelemedical Interventional Monitoring in Heart Failure (TIM-HF), a randomized, controlled intervention trial investigating the impact of telemedicine on mortality in ambulatory patients with heart failure:...(2010-11-24) Koehler, Friedrich; Winkler, Sebastian; Schieber, Michael; Sechtem, Udo; Stangl, Karl; Böhm, Michael; Boll, Herbert; Kim, Simone S; Koehler, Kerstin; Lücke, Stephanie; Honold, Marcus; Heinze, Peter; Schweizer, Thomas; Braecklein, Martin; Kirwan, Bridget-Anne; Gelbrich, Goetz; Anker, Stefan D; ,Remote patient management telemonitoring may help to detect early signs of cardiac decompensation allowing optimization of and adherence to treatments in chronic heart failure CHF Two meta analyses have suggested that telemedicine in CHF can reduce mortality by 30 35 The aim of the TIM HF study was to investigate the impact of telemedical management on mortality in ambulatory CHF patients Methods CHF patients New York Heart Association NYHA II III left ventricular ejection fraction LVEF 35 with a history of cardiac decompensation with hospitalization in the past or therapy with intravenous diuretics in the prior 24 months no decompensation required if LVEF 25 were randomized 1 1 to an intervention group of daily remote device monitoring electrocardiogram blood pressure body weight coupled with medical telephone support or to usual care led by the patients local physician In the intervention group 24 7 physician led medical support was provided by two central telemedical centres A clinical event committee blinded to treatment allocation assessed cause of death and reason for hospitalization The primary endpoint was total mortality The first secondary endpoint was a composite of cardiovascular mortality or hospitalization due to heart failure Other secondary endpoints included cardiovascular mortality all cause and cause specific hospitalizations all time to first event as well as days lost due to heart failure hospitalization or cardiovascular death in of follow up time and changes in quality of life and NYHA class Overall 710 CHF patients were recruited The mean follow up was 21 5 7 2 months with a minimum of 12 months Perspective The study will provide important prospective outcome data on the impact of telemedical management in patients with CHF