TY - CHAP A1 - Völler, Heinz A1 - Salzwedel, Annett A1 - Reibis, Rona Katharina A1 - Eichler, Sarah A1 - Buhlert, Hermann A1 - Kaminski, Stefan A1 - Wegscheider, Karl T1 - Cardiopulmonary exercise testing is predictive of return to work in cardiac patients after multicomponent rehabilitation T2 - European heart journal Y1 - 2015 SN - 0195-668X SN - 1522-9645 VL - 36 SP - 635 EP - 636 PB - Oxford Univ. Press CY - Oxford ER - TY - JOUR A1 - Völler, Heinz A1 - Salzwedel, Annett A1 - Nitardy, Aischa A1 - Buhlert, Hermann A1 - Treszl, Andras A1 - Wegscheider, Karl T1 - Effect of cardiac rehabilitation on functional and emotional status in patients after transcatheter aortic-valve implantation JF - European journal of preventive cardiology : the official ESC journal for primary & secondary cardiovascular prevention, rehabilitation and sports cardiology N2 - Background Transcatheter aortic-valve implantation (TAVI) is an established alternative therapy in patients with severe aortic stenosis and a high surgical risk. Despite a rapid growth in its use, very few data exist about the efficacy of cardiac rehabilitation (CR) in these patients. We assessed the hypothesis that patients after TAVI benefit from CR, compared to patients after surgical aortic-valve replacement (sAVR). Methods From September 2009 to August 2011, 442 consecutive patients after TAVI (n=76) or sAVR (n=366) were referred to a 3-week CR. Data regarding patient characteristics as well as changes of functional (6-min walk test. 6-MWT), bicycle exercise test), and emotional status (Hospital Anxiety and Depression Scale) were retrospectively evaluated and compared between groups after propensity score adjustment. Results Patients after TAVI were significantly older (p<0.001), more female (p<0.001), and had more often coronary artery disease (p=0.027), renal failure (p=0.012) and a pacemaker (p=0.032). During CR, distance in 6-MWT (both groups p0.001) and exercise capacity (sAVR p0.001, TAVI p0.05) significantly increased in both groups. Only patients after sAVR demonstrated a significant reduction in anxiety and depression (p0.001). After propensity scores adjustment, changes were not significantly different between sAVR and TAVI, with the exception of 6-MWT (p=0.004). Conclusions Patients after TAVI benefit from cardiac rehabilitation despite their older age and comorbidities. CR is a helpful tool to maintain independency for daily life activities and participation in socio-cultural life. KW - Cardiac rehabilitation KW - emotional status KW - functional capacity KW - surgical aortic valve replacement (sAVR) KW - transcatheter aortic valve implantation (TAVI) Y1 - 2015 U6 - https://doi.org/10.1177/2047487314526072 SN - 2047-4873 SN - 2047-4881 VL - 22 IS - 5 SP - 568 EP - 574 PB - Sage Publ. CY - London ER - TY - CHAP A1 - Völler, Heinz A1 - Eichler, Sarah A1 - Harnath, Axel A1 - Kamke, Wolfram A1 - Butter, Christian A1 - Kraehe, Mathias A1 - Schikora, Martin A1 - Jachczyk, J. A1 - Salzwedel, Annett T1 - Case management in patients after TAVI: are frailty and exercise capacitiy predictors for decision making process? T2 - European heart journal Y1 - 2015 SN - 0195-668X SN - 1522-9645 VL - 36 SP - 635 EP - 635 PB - Oxford Univ. Press CY - Oxford ER - TY - JOUR A1 - Skobel, Erik A1 - Kamke, Wolfram A1 - Bönner, Gerd A1 - Alt, Bernd A1 - Purucker, Hans-Christian A1 - Schwaab, Bernhard A1 - Einwang, Hans-Peter A1 - Schröder, Klaus A1 - Langheim, Eike A1 - Völler, Heinz A1 - Brandenburg, Alexandra A1 - Graml, Andrea A1 - Woehrle, Holger A1 - Krüger, Stefan T1 - Risk factors for, and prevalence of, sleep apnoea in cardiac rehabilitation facilities in Germany: The Reha-Sleep registry JF - European journal of preventive cardiology : the official ESC journal for primary & secondary cardiovascular prevention, rehabilitation and sports cardiology N2 - Aim To determine the prevalence of, and the risk factors for, sleep apnoea in cardiac rehabilitation (CR) facilities in Germany. Methods 1152 patients presenting for CR were screened for sleep-disordered breathing with 2-channel polygraphy (ApneaLink; ResMed). Parameters recorded included the apnoea-hypopnoea index (AHI), number of desaturations per hour of recording (ODI), mean and minimum nocturnal oxygen saturation and number of snoring episodes. Patients rated subjective sleep quality on a scale from 1 (poor) to 10 (best) and completed the Epworth Sleepiness Scale (ESS). Results Clinically significant sleep apnoea (AHI 15/h) was documented in 33% of patients. Mean AHI was 1416/h (range 0-106/h). Sleep apnoea was defined as being of moderate severity in 18% of patients (AHI 15-29/h) and severe in 15% (AHI 30/h). There were small, but statistically significant, differences in ESS score and subjective sleep quality between patients with and without sleep apnoea. Logistic regression model analysis identified the following as risk factors for sleep apnoea in CR patients: age (per 10 years) (odds ratio (OR) 1.51; p<0.001), body mass index (per 5 units) (OR 1.31; p=0.001), male gender (OR 2.19; p<0.001), type 2 diabetes mellitus (OR 1.45; p=0.040), haemoglobin level (OR 0.91; p=0.012) and witnessed apnoeas (OR 1.99; p<0.001). Conclusions The findings of this study indicate that more than one-third of patients undergoing cardiac rehabilitation in Germany have sleep apnoea, with one-third having moderate-to-severe SDB that requires further evaluation or intervention. Inclusion of sleep apnoea screening as part of cardiac rehabilitation appears to be appropriate. KW - Cardiac rehabilitation KW - sleep apnoea KW - sleep-disordered breathing Y1 - 2015 U6 - https://doi.org/10.1177/2047487314537916 SN - 2047-4873 SN - 2047-4881 VL - 22 IS - 7 SP - 820 EP - 830 PB - Sage Publ. CY - London ER - TY - GEN A1 - Skobel, Erik A1 - Kamke, Wolfram A1 - Bönner, Gerd A1 - Alt, Bernd A1 - Purucker, Hans-Christian A1 - Schwaab, Bernhard A1 - Einwang, Hans-Peter A1 - Schröder, Klaus A1 - Langheim, Eike A1 - Völler, Heinz A1 - Brandenburg, Alexandra A1 - Graml, Andrea A1 - Woehrle, Holger A1 - Krüger, Stefan T1 - Risk factors for, and prevalence of, sleep apnoea in cardiac rehabilitation facilities in Germany BT - the Reha-Sleep registry T2 - Postprints der Universität Potsdam : Humanwissenschaftliche Reihe N2 - Aim To determine the prevalence of, and the risk factors for, sleep apnoea in cardiac rehabilitation (CR) facilities in Germany. Methods 1152 patients presenting for CR were screened for sleep-disordered breathing with 2-channel polygraphy (ApneaLink; ResMed). Parameters recorded included the apnoea-hypopnoea index (AHI), number of desaturations per hour of recording (ODI), mean and minimum nocturnal oxygen saturation and number of snoring episodes. Patients rated subjective sleep quality on a scale from 1 (poor) to 10 (best) and completed the Epworth Sleepiness Scale (ESS). Results Clinically significant sleep apnoea (AHI 15/h) was documented in 33% of patients. Mean AHI was 1416/h (range 0-106/h). Sleep apnoea was defined as being of moderate severity in 18% of patients (AHI 15-29/h) and severe in 15% (AHI 30/h). There were small, but statistically significant, differences in ESS score and subjective sleep quality between patients with and without sleep apnoea. Logistic regression model analysis identified the following as risk factors for sleep apnoea in CR patients: age (per 10 years) (odds ratio (OR) 1.51; p<0.001), body mass index (per 5 units) (OR 1.31; p=0.001), male gender (OR 2.19; p<0.001), type 2 diabetes mellitus (OR 1.45; p=0.040), haemoglobin level (OR 0.91; p=0.012) and witnessed apnoeas (OR 1.99; p<0.001). Conclusions The findings of this study indicate that more than one-third of patients undergoing cardiac rehabilitation in Germany have sleep apnoea, with one-third having moderate-to-severe SDB that requires further evaluation or intervention. Inclusion of sleep apnoea screening as part of cardiac rehabilitation appears to be appropriate. T3 - Zweitveröffentlichungen der Universität Potsdam : Humanwissenschaftliche Reihe - 400 KW - cardiac rehabilitation KW - sleep apnoea KW - sleep-disordered breathing Y1 - 2018 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:kobv:517-opus4-404814 IS - 400 ER - TY - JOUR A1 - Salzwedel, Annett A1 - Wegscheider, Karl A1 - Herich, Lena A1 - Rieck, Angelika A1 - Strandt, Gert A1 - Völler, Heinz T1 - Impact of clinical and sociodemographic patient characteristics on the outcome of cardiac rehabilitation in older patients JF - Aging clinical and experimental research N2 - Background Cardiac rehabilitation (CR) seeks to simultaneously improve several outcome parameters related to patient risk factors, exercise capacity and subjective health. A single score, the multiple outcome criterion (MOC), comprised of alterations in 13 outcome variables was used to measure the overall success of CR in an older population. As this success depends on the older patient's characteristics at the time of admission to CR, we attempted to determine the most important influences. Methods The impact of baseline characteristics on the success of CR, measured by MOC, was analysed using a mixed model for 1,220 older patients (70.9 +/- A 7.0 years, 78.3 % men) who enrolled in 12 CR clinics. A multitude of potentially influential baseline patient characteristics was considered including sociodemographic variables, comorbidity, duration of hospital stay, exercise capacity, cardiovascular risk factors, emotional status, and laboratory and echocardiographic data. Results Overall, CR was successful, as indicated by the mean value of the MOC (0.6 +/- A 0.45; min -1.0, max 2.0; positive values denoting improvement, negative ones deterioration). Examples of association with negative MOC values included smoking (MOC -0.15, p < 0.001), female gender (MOC -0.07, p = 0.049), and a longer hospital stay (MOC -0.03, p = 0.03). An example of association with positive MOC value was depression score (MOC 0.06, p = 0.003). Further associations included maximal exercise capacity, blood pressure, heart rate and the rehabilitation centre attended. Conclusion Our results emphasize the necessity to take into consideration baseline characteristics when evaluating the success of CR and setting treatment targets for older patients. KW - Cardiac rehabilitation KW - Composite outcome measure KW - Predictors KW - Rehabilitation success KW - Older patients Y1 - 2015 U6 - https://doi.org/10.1007/s40520-014-0283-2 SN - 1594-0667 SN - 1720-8319 VL - 27 IS - 3 SP - 315 EP - 321 PB - Springer CY - New York ER - TY - JOUR A1 - Salzwedel, Annett A1 - Rieck, Angelika A1 - Reibis, Rona Katharina A1 - Völler, Heinz T1 - Routine initial exercise stress testing for treatment stratification in comprehensive cardiac rehabilitation JF - International journal of rehabilitation research N2 - There is evidence of substantial benefit of cardiac rehabilitation (CR) for patients with low exercise capacity at admission. Nevertheless, some patients are not able to perform an initial exercise stress test (EST). We aimed to describe this group using data of 1094 consecutive patients after a cardiac event (71 +/- 7 years, 78% men) enrolled in nine centres for inpatient CR. We analysed sociodemographic and clinical variables (e.g. cardiovascular risk factors, comorbidities, complications at admission), amount of therapy (e.g. exercise training, nursing care) and the results of the initial and the final 6-min walking test (6MWT) with respect to the application of an EST. Fifteen per cent of patients did not undergo an EST (non-EST group). In multivariable analysis, the probability of obtaining an EST was higher for men [odds ratio (OR) 1.89, P=0.01], a 6MWT (per 10 m, OR 1.07, P<0.01) and lower for patients with diabetes mellitus (OR 0.48, P<0.01), NYHA-class III/IV (OR 0.27, P<0.01), osteoarthritis (OR 0.39, P<0.01) and a longer hospital stay (per 5 days, OR 0.87, P=0.02). The non-EST group received fewer therapy units of exercise training, but more units of nursing care and physiotherapy than the EST group. However, there were no significant differences between both groups in the increase of the 6MWT during CR (123 vs. 108 m, P=0.122). The present study confirms the feasibility of an EST at the start of CR as an indicator of disease severity. Nevertheless, patients without EST benefit from CR even if exercising less. Thus, there is a justified need for individualized, comprehensive and interdisciplinary CR. KW - disease severity KW - exercise stress test KW - multimodal cardiac rehabilitation KW - rehabilitation outcome KW - therapy volume Y1 - 2015 U6 - https://doi.org/10.1097/MRR.0000000000000133 SN - 0342-5282 SN - 1473-5660 VL - 38 IS - 4 SP - 344 EP - 349 PB - Lippincott Williams & Wilkins CY - Philadelphia ER - TY - JOUR A1 - Reibis, Rona Katharina A1 - Jannowitz, Christina A1 - Halle, Martin A1 - Pittrow, David A1 - Gitt, Anselm A1 - Völler, Heinz T1 - Management and outcomes of patients with reduced ejection fraction after acute myocardial infarction in cardiac rehabilitation centers JF - Current medical research and opinion N2 - Background: We aimed to describe the contemporary management of patients with systolic chronic heart failure (CHF) during a cardiac rehabilitation (CR) stay and present outcomes with focus on lipids, blood pressure, exercise capacity, and clinical events. Methods: Comparison of 3199 patients with moderately or severely impaired left ventricular ejection fraction (low EF, 13.3%) and 20,913 patients with slightly reduced or normal LVEF (normal EF, 86.7%) who underwent an inpatient CR period of about 3 weeks in 2009-2010. Results: Patients with low EF compared to those with normal EF were somewhat older (65.1 vs. 63.0 years, p<0.0001), and more often had risk factors such as diabetes mellitus (39.7% vs. 32.0%, p<0.0001) or other comorbidities. The overall rate of patients with regular physical activity of at least 90 minutes per week prior to CR was low overall (54.4%), and reduced in patients with low EF compared to those with normal EF (47.7% vs. 55.5%, p<0.0001). The rate of patients that achieved lower LDL cholesterol (5100 mg/dl), total cholesterol (<200 mg/dl) and triglyceride (<150 mg/dl) values at discharge increased compared to baseline. Mean blood pressure was substantially lower in the low EF group compared to the normal EF group both at baseline (124/75 vs. 130/78 mmHg, p<0.0001) and at discharge (119/72 vs. 124/74 mmHg, p<0.0001). Maximum exercise improved substantially in both groups (at baseline 71 vs. 91 Watts, p<0.0001; at discharge 85 vs. 105 Watts, p<0.0001). Event rates during CR were low, and only 0.3% in the low EF group died. As limitations to this study, information on brain natriuretic peptide (BNP), N-terminal pro-brain natriuretic peptide (NT-pro BNP) and/or cardiac troponin were not documented, and no long-term information was collected beyond the 3-week CR stay. Conclusions: Patients with CHF account for a considerable proportion of patients in CR. Also patients with moderate/severe EF benefited from participation in CR, as their lipid profile and physical fitness improved. KW - Acute myocardial infarction KW - Cardiac rehabilitation Chronic heart failure KW - Control rates KW - Dyslipidemia KW - Lipid profile KW - Observational KW - Risk factor Y1 - 2015 U6 - https://doi.org/10.1185/03007995.2014.977854 SN - 0300-7995 SN - 1473-4877 VL - 31 IS - 2 SP - 211 EP - 219 PB - Taylor & Francis Group CY - London ER - TY - JOUR A1 - Reibis, Rona Katharina A1 - Huber, Matthias A1 - Karoff, Marthin A1 - Kamke, Wolfram A1 - Kreutz, Reinhold A1 - Wegscheider, Karl A1 - Völler, Heinz T1 - Target organ damage and control of cardiovascular risk factors in hypertensive patients Evidence from the multicenter ESTher registry JF - Herz : cardiovascular diseases N2 - This study investigated the incidence of hypertensive target organ damage (TOD), control of cardiovascular risk factors, and the short-term prognosis in hypertensive patients under contemporary guideline-oriented therapy. A total of 1,377 consecutive patients (mean age 58.2 +/- 9.9 years, 82.2 % male) with arterial hypertension were included in the ESTher (Endorganschaden, Therapie und Verlauf - target organ damage, therapy, and course) registry at 15 rehabilitation clinics within the framework of the National Genome Research Network. Cardiovascular risk factors, medication, comorbidities, and glomerular filtration rate (GFR) were assessed. Left ventricular hypertrophy (LVH), left ventricular mass (LVM), left ventricular mass index (LVMI), and left ventricular ejection fraction (LVEF) were determined by two-dimensional echocardiography. The mean follow-up was 513 +/- 159 days. Changes in continuous parameters were tested by the t test, changes in discrete characteristics are presented by means of transition tables and tested with the McNemar test. The mean LVEF was 59.3 +/- 9.9 %, both mean LVM (238.6 +/- 101.5 g) and LVMI (54.0 +/- 23.6 g/m(2.7)) were increased while relative wall thickness (RWT, 0.46 +/- 0.18) indicated the presence of concentric LVH. Of the patients, 10.2 % displayed renal dysfunction (estimated GFR < 60 ml/min/1.73 m(2)). The 1.5-year overall mortality was 1.2 %. Compared with discharge, at follow-up the proportion of patients with blood pressure (BP) values < 140/90 mmHg decreased from 68.7 % to 55.0 % (p < 0.001) and with low-density lipoprotein (LDL) values < 100 mg/dl from 62.6 % to 38.1 % (p < 0.001). At follow-up significantly more patients displayed a GFR value of < 60 ml/min/1.73 m(2) (10.2 % vs. 16.0 %, p < 0.001). A significant proportion of hypertensive rehabilitation participants displayed TOD including LVH and renal dysfunction. Even after stringent BP reduction, a considerable increase in nephropathy could be found after 18 months. KW - Arterial hypertension KW - Prospective study KW - Left ventricular hypertrophy KW - Glomerular filtration rate KW - Cardiac rehabilitation Y1 - 2015 U6 - https://doi.org/10.1007/s00059-014-4189-8 SN - 0340-9937 SN - 1615-6692 VL - 40 SP - 209 EP - 216 PB - Urban & Vogel CY - München ER - TY - JOUR A1 - Piepoli, Massimo F. A1 - Corra, Ugo A1 - Abreu, Ana A1 - Cupples, Margaret A1 - Davos, Costantinos A1 - Doherty, Patrick A1 - Hoefer, Stephan A1 - Garcia-Porrero, Esteban A1 - Rauchi, Bernhard A1 - Vigorito, Carlo A1 - Völler, Heinz A1 - Schmid, Jean-Paul T1 - Challenges in secondary prevention of cardiovascular diseases A review of the current practice JF - International journal of cardiology N2 - With the changing demography of populations and increasing prevalence of co-morbidity, frail patients and more complex cardiac conditions, the modern medicine is facing novel challenges leading to rapid innovation where evidence and experiences are lacking. This scenario is also evident in cardiovascular disease prevention, which continuously needs to accommodate its ever changing strategies, settings, and goals. The present paper summarises actual challenges of secondary prevention, and discusses how this intervention should not only be effective but also efficient. By this way the paper tries to bridge the gaps between research and real-world findings and thereby may find ways to improve standard care. (C) 2014 Elsevier Ireland Ltd. All rights reserved. KW - Cardiac rehabilitation KW - Cardiovascular risk factor KW - Long term management KW - Secondary prevention Y1 - 2015 U6 - https://doi.org/10.1016/j.ijcard.2014.11.107 SN - 0167-5273 SN - 1874-1754 VL - 180 SP - 114 EP - 119 PB - Elsevier CY - Clare ER - TY - JOUR A1 - Muckelbauer, Rebecca A1 - Englert, Heike A1 - Rieckmann, Nina A1 - Chen, Chih-Mei A1 - Wegscheider, Karl A1 - Völler, Heinz A1 - Katus, Hugo A. A1 - Willich, Stefan N. A1 - Müller-Nordhorn, Jacqueline T1 - Long-term effect of a low-intensity smoking intervention embedded in an adherence program for patients with hypercholesterolemia: Randomized controlled trial JF - Preventive medicine : an international journal devoted to practice and theory N2 - Objective. We evaluated the long-term effect of a smoking intervention embedded in an adherence program in patients with an increased risk for cardiovascular disease. Method. Secondary analysis of a randomized controlled trial: In 2002-2004,8108 patients with hypercholesterolemia were enrolled from general practices in Germany. Patients received a 12-month adherence program and statin medication (intervention) or statin medication only (control). The program aimed to improve adherence to medication and lifestyle by educational material, mailings, and phone calls. Smoking was self-reported at baseline and every 6 months during the 3-year follow-up. Results. In total, 7640 patients were analyzed. At baseline, smoking prevalence was 21.7% in the intervention and 21.5% in the control group. Prevalence decreased in both groups to 16.6% vs. 19.5%, 153% vs. 16.8%, and 14.2% vs. 15.6% at the 12-, 24-, and 36-month follow-up. The intervention had a beneficial effect on smoking differing over time (group x time: P = 0.005). The effect was largest after 6 and 12 months [odds ratios (95% confidence intervals): 0.67 (0.54-0.82) and 0.63 (0.51-0.78)]. The effect decreased until the 18-month follow-up [0.72 (0.58-0.90)] and was not significant after 24 months. Conclusion. A low-intensity smoking intervention embedded in an adherence program can contribute to smoking cessation although the intervention effect diminished over time. (C) 2015 Elsevier Inc. All rights reserved. KW - Smoking KW - Smoking cessation KW - Cardiovascular risk factors KW - Health promotion KW - Randomized controlled trial KW - Multiple risk factor intervention KW - Hypercholesterolemia Y1 - 2015 U6 - https://doi.org/10.1016/j.ypmed.2015.05.026 SN - 0091-7435 SN - 1096-0260 VL - 77 SP - 155 EP - 161 PB - Elsevier CY - San Diego ER - TY - JOUR A1 - Huber, Matthias A1 - Lezius, Susanne A1 - Reibis, Rona Katharina A1 - Treszl, Andras A1 - Kujawinska, Dorota A1 - Jakob, Stefanie A1 - Wegscheider, Karl A1 - Völler, Heinz A1 - Kreutz, Reinhold T1 - A Single Nucleotide Polymorphism near the CYP17A1 Gene Is Associated with Left Ventricular Mass in Hypertensive Patients under Pharmacotherapy JF - International journal of molecular sciences N2 - Cytochrome P450 17A1 (CYP17A1) catalyses the formation and metabolism of steroid hormones. They are involved in blood pressure (BP) regulation and in the pathogenesis of left ventricular hypertrophy. Therefore, altered function of CYP17A1 due to genetic variants may influence BP and left ventricular mass. Notably, genome wide association studies supported the role of this enzyme in BP control. Against this background, we investigated associations between single nucleotide polymorphisms (SNPs) in or nearby the CYP17A1 gene with BP and left ventricular mass in patients with arterial hypertension and associated cardiovascular organ damage treated according to guidelines. Patients (n = 1007, mean age 58.0 +/- 9.8 years, 83% men) with arterial hypertension and cardiac left ventricular ejection fraction (LVEF) 40% were enrolled in the study. Cardiac parameters of left ventricular mass, geometry and function were determined by echocardiography. The cohort comprised patients with coronary heart disease (n = 823; 81.7%) and myocardial infarction (n = 545; 54.1%) with a mean LVEF of 59.9% +/- 9.3%. The mean left ventricular mass index (LVMI) was 52.1 +/- 21.2 g/m(2.7) and 485 (48.2%) patients had left ventricular hypertrophy. There was no significant association of any investigated SNP (rs619824, rs743572, rs1004467, rs11191548, rs17115100) with mean 24 h systolic or diastolic BP. However, carriers of the rs11191548 C allele demonstrated a 7% increase in LVMI (95% CI: 1%-12%, p = 0.017) compared to non-carriers. The CYP17A1 polymorphism rs11191548 demonstrated a significant association with LVMI in patients with arterial hypertension and preserved LVEF. Thus, CYP17A1 may contribute to cardiac hypertrophy in this clinical condition. KW - clinical study KW - genetics KW - heart KW - hypertension KW - cytochrome P450 17A1 (Cyp17A1) Y1 - 2015 U6 - https://doi.org/10.3390/ijms160817456 SN - 1422-0067 VL - 16 IS - 8 SP - 17456 EP - 17468 PB - MDPI CY - Basel ER - TY - JOUR A1 - Hofmann, Reiner A1 - Völler, Heinz A1 - Nagels, Klaus A1 - Bindl, Dominik A1 - Vettorazzi, Eik A1 - Dittmar, Ronny A1 - Wohlgemuth, Walter A1 - Neumann, Till A1 - Störk, Stefan A1 - Bruder, Oliver A1 - Wegscheider, Karl A1 - Nagel, Eckhard A1 - Fleck, Eckart T1 - First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEAT JF - Trials N2 - Background: Evidence that home telemonitoring for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage. Methods: Between January 2010 and June 2013, patients with a confirmed diagnosis of CHF were enrolled and randomly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system (Motiva (R)). The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio (ICER) established by the groups' difference in total cost and in the combined clinical endpoint "days alive and not in hospital nor inpatient care per potential days in study" within the follow-up of 12 months. Results: A total of 621 predominantly male patients were enrolled, whereof 302 patients were assigned to the intervention group and 319 to the control group. Ischemic cardiomyopathy was the leading cause of heart failure. Despite randomization, subjects of the control group were more often in NYHA functional class III-IV, and exhibited peripheral edema and renal dysfunction more often. Additionally, the control and intervention groups differed in heart rhythm disorders. No differences existed regarding risk factor profile, comorbidities, echocardiographic parameters, especially left ventricular and diastolic diameter and ejection fraction, as well as functional test results, medication and quality of life. While the observed baseline differences may well be a play of chance, they are of clinical relevance. Therefore, the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances. Conclusions: CardioBBEAT provides prospective outcome data on both, clinical and health economic impact of home telemonitoring in CHF. The study differs by the use of a high evidence level randomized controlled trial (RCT) design along with actual cost data obtained from health insurance companies. Its results are conducive to informed political and economic decision-making with regard to home telemonitoring solutions as an option for health care. Overall, it contributes to developing advanced health economic evaluation instruments to be deployed within the specific context of the German Health Care System. KW - Home telemonitoring KW - Chronic heart failure (CHF) KW - Incremental Cost-Effectiveness Ratio (ICER) KW - Mortality KW - Telemedicine KW - Health economics Y1 - 2015 U6 - https://doi.org/10.1186/s13063-015-0886-8 SN - 1745-6215 VL - 16 PB - BioMed Central CY - London ER -