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1.
Eur J Heart Fail ; 21(9): 1142-1148, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31343108

RESUMO

BACKGROUND: Exercise training programmes (ETPs) are a crucial component in cardiac rehabilitation in heart failure (HF) patients. The Exercise Training in HF (ExTraHF) survey has reported poor implementation of ETPs in countries affiliated to the European Society of Cardiology (ESC). The aim of the present sub-analysis was to investigate the regional variations in the implementation of ETPs for HF patients. METHODS AND RESULTS: The study was designed as a web-based survey of cardiac units, divided into five areas, according to the geographical location of the countries surveyed. Overall, 172 centres replied to the survey, in charge of 78 514 patients, differentiated in 52 Northern (n = 15 040), 48 Southern (n = 27 127), 34 Western (n = 11 769), 24 Eastern European (n = 12 748), and 14 extra-European centres (n = 11 830). Greater ETP implementation was observed in Western (76%) and Northern (63%) regions, whereas lower rates were seen in Southern (58%), Eastern European (50%) and extra-European (36%) regions. The leading barrier was the lack of resources in all (83-65%) but Western region (37%) where patients were enrolled in dedicated settings and specialized units (75%). In 40% of centres, non-inclusion of ETP in the national or local guideline pathway accounted for the lack of ETP implementation. CONCLUSION: Exercise training programmes are poorly implemented in the ESC affiliated countries, mainly because of the lack of resources and/or national and local guidelines. The linkage with dedicated cardiac rehabilitation centres (as in the Western region) or the model of local rehabilitation services adopted in Northern countries may be considered as options to overcome these gaps.

3.
Eur J Heart Fail ; 2019 May 26.
Artigo em Inglês | MEDLINE | ID: mdl-31129923

RESUMO

The European Society of Cardiology (ESC) has published a series of guidelines on heart failure (HF) over the last 25 years, most recently in 2016. Given the amount of new information that has become available since then, the Heart Failure Association (HFA) of the ESC recognized the need to review and summarise recent developments in a consensus document. Here we report from the HFA workshop that was held in January 2019 in Frankfurt, Germany. This expert consensus report is neither a guideline update nor a position statement, but rather a summary and consensus view in the form of consensus recommendations. The report describes how these guidance statements are supported by evidence, it makes some practical comments, and it highlights new research areas and how progress might change the clinical management of HF. We have avoided re-interpretation of information already considered in the 2016 ESC/HFA guidelines. Specific new recommendations have been made based on the evidence from major trials published since 2016, including sodium-glucose co-transporter 2 inhibitors in type 2 diabetes mellitus, MitraClip for functional mitral regurgitation, atrial fibrillation ablation in HF, tafamidis in cardiac transthyretin amyloidosis, rivaroxaban in HF, implantable cardioverter-defibrillators in non-ischaemic HF, and telemedicine for HF. In addition, new trial evidence from smaller trials and updated meta-analyses have given us the chance to provide refined recommendations in selected other areas. Further, new trial evidence is due in many of these areas and others over the next 2 years, in time for the planned 2021 ESC guidelines on the diagnosis and treatment of acute and chronic heart failure.

4.
Eur J Heart Fail ; 21(5): 553-576, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30989768

RESUMO

Cardiomyopathies are a heterogeneous group of heart muscle diseases and an important cause of heart failure (HF). Current knowledge on incidence, pathophysiology and natural history of HF in cardiomyopathies is limited, and distinct features of their therapeutic responses have not been systematically addressed. Therefore, this position paper focuses on epidemiology, pathophysiology, natural history and latest developments in treatment of HF in patients with dilated (DCM), hypertrophic (HCM) and restrictive (RCM) cardiomyopathies. In DCM, HF with reduced ejection fraction (HFrEF) has high incidence and prevalence and represents the most frequent cause of death, despite improvements in treatment. In addition, advanced HF in DCM is one of the leading indications for heart transplantation. In HCM, HF with preserved ejection (HFpEF) affects most patients with obstructive, and ∼10% of patients with non-obstructive HCM. A timely treatment is important, since development of advanced HF, although rare in HCM, portends a poor prognosis. In RCM, HFpEF is common, while HFrEF occurs later and more frequently in amyloidosis or iron overload/haemochromatosis. Irrespective of RCM aetiology, HF is a harbinger of a poor outcome. Recent advances in our understanding of the mechanisms underlying the development of HF in cardiomyopathies have significant implications for therapeutic decision-making. In addition, new aetiology-specific treatment options (e.g. enzyme replacement therapy, transthyretin stabilizers, immunoadsorption, immunotherapy, etc.) have shown a potential to improve outcomes. Still, causative therapies of many cardiomyopathies are lacking, highlighting the need for the development of effective strategies to prevent and treat HF in cardiomyopathies.

5.
Eur J Prev Cardiol ; 26(10): 1028-1031, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30861694

RESUMO

BACKGROUND: The aim of this study was to compare the acute effects produced by a single bout of three different exercise modalities on short-term blood pressure variability. METHODS: The study enrolled 21 sedentary male patients with hypertension and a mean age of 63 ± 7.2 years. Blood pressure variability was evaluated through ambulatory blood pressure monitoring that was performed twice: during an ordinary daily activity and after an exercise session lasting 60 minutes. Patients were divided into three groups according to the different exercise modality performed during the session: aerobic continuous training, interval training or combined training including aerobic and resistance training. RESULTS: Twenty-four-hour systolic blood pressure variability increased in the interval training group, was unchanged in the aerobic continuous training group and decreased in the combined training group (intergroup P = 0.03). Daytime systolic blood pressure variability increased in the interval training and aerobic continuous training groups while it decreased in the combined training group (intergroup P = 0.0006). Twenty-four-hour diastolic blood pressure variability decreased in the aerobic continuous training and combined training groups while it increased in the interval training group (intergroup P = 0.002). CONCLUSION: Different training modalities have similar hypotensive action but exert different acute effects on blood pressure variability. Combined training seems to be the most suitable training modality for sedentary men with hypertension.

6.
Curr Sports Med Rep ; 17(12): 473-479, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30531466

RESUMO

Exercise training is increasingly promoted for physical and mental health and represents a major factor in both primary and secondary prevention of cardiovascular (CV) diseases. The beneficial effects of exercise, in part, can be ascribed to adaptations of neural CV regulation through several mechanisms. In this article, we summarize how exercise training affects neural CV regulation and outline the plasticity of neural network in the continuum from cardiac patients to elite athletes.


Assuntos
Sistema Nervoso Autônomo/fisiologia , Doenças Cardiovasculares/prevenção & controle , Sistema Cardiovascular , Exercício/fisiologia , Adaptação Fisiológica , Atletas , Humanos , Rede Nervosa , Plasticidade Neuronal
7.
Am J Cardiol ; 2018 Oct 19.
Artigo em Inglês | MEDLINE | ID: mdl-30420184

RESUMO

High-dose statin (HDS) therapy is recommended to reduce low-density lipoprotein cholesterol (LDL-C); however, some patients are unable to tolerate the associated side effects. Nutraceuticals have shown efficacy in lowering LDL-C. The aim of this study was to evaluate whether the combination of low-dose statin (LDS) plus ezetimibe (EZE) or LDS plus nutraceutical (Armolipid Plus [ALP] containing red yeast rice, policosanol, and berberine) can lead to a higher proportion of high-risk patients achieving target LDL-C. A secondary objective was to assess the efficacy of triple combination LDS + EZE + ALP in resistant patients (LDL-C >70 mg/dl). A randomized, prospective, parallel-group, single-blind study was conducted in patients with coronary artery disease (n = 100) who had undergone percutaneous coronary intervention in the preceding 12 months, were HDS-intolerant, and were not at LDL-C target (<70 mg/dl) with LDS alone. Patients received either LDS + EZE or LDS + ALP. Of the 100 patients, 33 patients (66%) treated with LDS + EZE and 31 patients (62%) treated with LDS + ALP achieved target LDL-C after 3 months, which was maintained at 6 months. Patients who did not achieve the therapeutic goal received a triple combination of LDS + EZE + ALP for a further 3 months. At 6 months, 28 of 36 patients (78%) achieved LDL-C target. Overall, 92% of patients enrolled in this study were at target LDL-C at 6 months. No patients in any group experienced major side effects. In conclusion, in HDS-intolerant coronary artery disease patients, the combination of LDS plus EZE and/or ALP represents a valuable therapeutic option allowing most patients to reach target LDL-C within 3 to 6 months.

8.
Eur J Heart Fail ; 2018 Nov 26.
Artigo em Inglês | MEDLINE | ID: mdl-30474896

RESUMO

Exercise training (ET) and secondary prevention measures in cardiovascular disease aim to stimulate early physical activity and to facilitate recovery and improve health behaviours. ET has also been proposed for heart failure patients with a ventricular assist device (VAD), to help recovery in the patient's functional capacity. However, the existing evidence in support of ET in these patients remains limited. After a review of current knowledge on the causes of the persistence of limitation in exercise capacity in VAD recipients, and concerning the benefit of ET in VAD patients, the Heart Failure Association of the European Society of Cardiology has developed the present document to provide practical advice on implementing ET. This includes appropriate screening to avoid complications and then starting with early mobilisation, ET prescription is individualised to meet the patient's needs. Finally, gaps in our knowledge are discussed.

9.
Intern Emerg Med ; 13(7): 1069-1075, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29956065

RESUMO

In the past few years, new oral anticoagulants (NOACs) targeting directly a single activated clotting factor, have been developed for the treatment of non-valvular atrial fibrillation (AF), which are currently recommended as first-line therapy in AF. The aim of this study is to provide an overall picture on the extent to which oral anticoagulation (OAC) with NOACs correspond to actually prescribed OAC therapy in an unselected, real world, population of consecutive patients with AF in Italy. Compliance with the therapy and quality of life were also assessed. A 50 cardiology unit network located in different geographic areas of Italy enrolled a total of 1742 consecutive outpatients with AF (54.6% males, 45.4% females, mean age 72.5 years). NOACs were prescribed in 56.1% patients and VKA in 43.9% (P < 0.0001). NOACs were significantly more prescribed than VKA in patients with high thrombo-embolic risk score (i.e., CHA2DS2-VASc > 2) (78.2 vs 67.3%, P < 0.0001), but also patients at low risk (i.e., CHA2DS2-VASc < 1 and HAS-BLED < 3) were still under OAC therapy with either NOACs (27%) or VKA (73%). Adherence to therapy (Morisky test) was greater in patients taking NOACs as was the quality of life. The ISPAF-2 study shows that in an Italian population of real-world patients with AF the prescription of OAC according to current guidelines and stroke-risk scoring system is rather high although it still needs to be improved. Contrary to recommendations, in a high proportion of low-risk patients, anticoagulation therapy, with either NOACs and VKA is still prescribed, and this exposes patients to unjustified risks.

10.
Int J Mol Sci ; 19(3)2018 Mar 10.
Artigo em Inglês | MEDLINE | ID: mdl-29534462

RESUMO

Diabetes mellitus is one the strongest risk factors for cardiovascular disease and, in particular, for ischemic heart disease (IHD). The pathophysiology of myocardial ischemia in diabetic patients is complex and not fully understood: some diabetic patients have mainly coronary stenosis obstructing blood flow to the myocardium; others present with coronary microvascular disease with an absence of plaques in the epicardial vessels. Ion channels acting in the cross-talk between the myocardial energy state and coronary blood flow may play a role in the pathophysiology of IHD in diabetic patients. In particular, some genetic variants for ATP-dependent potassium channels seem to be involved in the determinism of IHD.


Assuntos
Diabetes Mellitus/metabolismo , Canais Iônicos/metabolismo , Isquemia Miocárdica/metabolismo , Animais , Circulação Coronária , Diabetes Mellitus/fisiopatologia , Humanos , Isquemia Miocárdica/fisiopatologia
11.
Age Ageing ; 47(1): 82-88, 2018 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-28985325

RESUMO

Background: chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) frequently coexist in older people, reducing patients' quality of life (QoL) and increasing morbidity and mortality. Objective: we studied the feasibility and efficacy of an integrated telerehabilitation home-based programme (Telereab-HBP), 4 months long, in patients with combined COPD and CHF. The primary outcome was exercise tolerance evaluated at the 6-min walk test (6MWT). Secondary outcomes were time-to-event (hospitalisation and death), dyspnoea (MRC), physical activity profile (PASE), disability (Barthel) and QoL (MLHFQ and CAT). Study design: randomised, open, controlled, multicenter trial. Methods: the Telereab-HBP included remote monitoring of cardiorespiratory parameters, weekly phone-calls by the nurse, and exercise programme, monitored weekly by the physiotherapist. All outcomes were studied again after 2 months of a no-intervention period. Results: in total, 112 patients were randomised, 56 per group. Their mean (SD) age was 70 (9) years, and 92 (82.1%) were male. After 4 months, the IG were able to walk further than at baseline: mean (95% CI) Δ6MWT was 60 (22.2,97.8) m; the CG showed no significant improvement: -15 (-40.3,9.8) m; P = 0.0040 between groups. In IG, the media time to hospitalisation/death was 113.4 days compared with 104.7 in the CG (P = 0.0484, log-rank test). Other secondary outcomes: MRC (P = 0.0500), PASE (P = 0.0015), Barthel (P = 0.0006), MLHFQ (P = 0.0007) and CAT (P = 0.0000) were significantly improved in the IG compared with the CG at 4 months. IG maintained the benefits acquired at 6 months for outcomes. Conclusions: this 4-month Telereab-HBP was feasible and effective in older patients with combined COPD and CHF.


Assuntos
Reabilitação Cardíaca/métodos , Terapia por Exercício/métodos , Insuficiência Cardíaca/reabilitação , Serviços Hospitalares de Assistência Domiciliar , Doença Pulmonar Obstrutiva Crônica/reabilitação , Terapia Respiratória/métodos , Telerreabilitação/métodos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Reabilitação Cardíaca/efeitos adversos , Reabilitação Cardíaca/mortalidade , Avaliação da Deficiência , Terapia por Exercício/efeitos adversos , Terapia por Exercício/mortalidade , Tolerância ao Exercício , Estudos de Viabilidade , Feminino , Avaliação Geriátrica/métodos , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Humanos , Itália , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Admissão do Paciente , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/mortalidade , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Qualidade de Vida , Recuperação de Função Fisiológica , Terapia Respiratória/efeitos adversos , Terapia Respiratória/mortalidade , Fatores de Risco , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento , Teste de Caminhada
13.
Am J Cardiol ; 120(6): 893-897, 2017 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-28781026

RESUMO

Low-density lipoprotein cholesterol (LDL-C) reduction is associated with a significant decrease in mortality, and statins represent the most effective drugs to achieve this. However, side effects of statins are very common and may lead to treatment discontinuation. Nutraceuticals are a combination of natural components that have shown efficacy in lowering LDL-C concentration when used alone or in association with other agents in patients who are intolerant to high-dose statins. Our aim was to compare the efficacy and tolerability of low-dose statin (LDS) therapy versus combined therapy of LDS plus a nutraceutical combination containing red yeast rice, policosanol, berberine, folic acid, coenzyme Q10 and astaxanthin (Armolipid Plus) in high-risk patients. We performed a randomized (1:1), prospective, parallel group, single-blind trial in which participants had coronary artery disease (n = 100), had undergone percutaneous coronary intervention in the preceding 12 months, were high-dose statin intolerant, and did not achieve ≥50% reduction in LDL-C with LDS treatment alone. After 3 months, patients in the LDS + Armolipid Plus (n = 50) group presented with a significantly greater reduction of LDL-C and total cholesterol (p <0.0001), and 70% of patients in this group achieved the therapeutic target (LDL-C <70 mg/dl), whereas patients in the LDS group did not. Six patients (3 from each group) dropped out due to myalgia. In conclusion, in patients with coronary artery disease and high-dose statin intolerance, the combination of LDS and nutraceuticals represents a valuable therapeutic option.


Assuntos
Produtos Biológicos/administração & dosagem , Doença da Artéria Coronariana/terapia , Suplementos Nutricionais , Tolerância a Medicamentos , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Intervenção Coronária Percutânea , Idoso , Colesterol/sangue , Doença da Artéria Coronariana/sangue , Relação Dose-Resposta a Droga , Combinação de Medicamentos , Quimioterapia Combinada , Feminino , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Método Simples-Cego , Resultado do Tratamento
15.
Card Fail Rev ; 3(1): 40-45, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28785474

RESUMO

Despite the availability of new drugs and devices, the treatment of cardiovascular disease remains suboptimal. Single-pill combination therapy offers a number of potential advantages. It can combine different classes of drugs to increase efficacy while mitigating the risks of treatment-related adverse events, reduce pill burden, lower medical cost, and improve patient adherence. Furthermore, in hypertension, single pill combinations include standard to lower doses of each drug than would be necessary to achieve goals with monotherapy, which may explain their better tolerability compared with higher dose monotherapy. Combination therapy is now established in the treatment of hypertension. In ischaemic heart disease, the concept of a preventative polypill has been studied, but its benefits have not been established conclusively. However, the combination of ivabradine and beta-blockers has proven efficacy in patients with stable angina pectoris. This combination has also demonstrated benefits in patients with chronic heart failure.

16.
Int J Cardiol ; 226: 132-135, 2017 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-27184730

RESUMO

In heart failure, in addition to the renin-angiotensin-aldosterone system and sympathetic nervous system, the natriuretic peptide (NP) system plays a fundamental role among compensating mechanisms. The NPs undergo rapid enzymatic degradation that limits their vasorelaxant, natriuretic, and diuretic actions. Degradation of NPs is partially due to the action of neprilysin, which is a membrane-bound endopeptidase found in many tissues. This article summarizes recent findings on a new natriuretic peptide-enhancing drug and their implication for future pharmacological treatment of patients suffering from heart failure with reduced ejection fraction.


Assuntos
Antagonistas de Receptores de Angiotensina/uso terapêutico , Insuficiência Cardíaca/tratamento farmacológico , Neprilisina/antagonistas & inibidores , Sistema Renina-Angiotensina/efeitos dos fármacos , Volume Sistólico/efeitos dos fármacos , Sistema Nervoso Simpático/efeitos dos fármacos , Antagonistas de Receptores de Angiotensina/farmacologia , Doença Crônica , Insuficiência Cardíaca/fisiopatologia , Humanos , Neprilisina/fisiologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Sistema Renina-Angiotensina/fisiologia , Volume Sistólico/fisiologia , Sistema Nervoso Simpático/fisiologia
17.
Int J Cardiol ; 226: 136-140, 2017 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-27378659

RESUMO

Sacubritil∗valsartan (Entresto, Novartis, still commonly referred to as LCZ696) is a combination drug described as a new class of dual-acting angiotensin receptor-neprilysin inhibitor (ARNi). This combination drug has been successfully studied in patients with heart failure with both preserved (HFpEF) and reduced ejection fraction (HFrEF). In this review, the evidences in patients with HFpEF and HFrEF are summarized, including the results of more recent studies.


Assuntos
Aminobutiratos/uso terapêutico , Antagonistas de Receptores de Angiotensina/uso terapêutico , Insuficiência Cardíaca/tratamento farmacológico , Neprilisina/antagonistas & inibidores , Sistema Renina-Angiotensina/efeitos dos fármacos , Tetrazóis/uso terapêutico , Aminobutiratos/farmacologia , Bloqueadores do Receptor Tipo 1 de Angiotensina II/farmacologia , Bloqueadores do Receptor Tipo 1 de Angiotensina II/uso terapêutico , Antagonistas de Receptores de Angiotensina/farmacologia , Ensaios Clínicos como Assunto/métodos , Insuficiência Cardíaca/fisiopatologia , Humanos , Neprilisina/metabolismo , Sistema Renina-Angiotensina/fisiologia , Tetrazóis/farmacologia
18.
Int J Cardiol ; 227: 217-221, 2017 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-27843051

RESUMO

Drospirenone (DRSP) is an antialdosterone agent with progestogenic and antiandrogenic effects. This compound, has been recently used in combination with 17ß-estradiol (E2) as hormonal therapy in postmenopausal women and has been shown to exert a significant antihypertensive effect in hypertensive post-menopausal women. Aim of the present study was to compare the effect of DRSP/E2 with those of Tibolone (T) on endothelial function, arterial stiffness, and lipid profile of early postmenopausal women naïve on post-menopausal hormonal therapy. Twenty-four women met the inclusion criteria and entered the study. Women were randomized to receive either DRSP/E2 or T for 6months. Blood pressure and heart rate were similar in both groups at baseline and at the end of the study. Compared to baseline, endothelial function assessed by Reactive Hyperemia (RH) significantly improved in women receiving E2/DRSP, whereas no significant differences between baseline and follow up were detected in women receiving Tibolone. Women receiving E2/DRSP showed a significant decrease in pulse wave velocity and Augmentation Index compared to baseline while no changes were observed in women receiving Tibolone. The capacity of sera to trigger endothelial cells apoptosis in vitro measured by cell death assay was significantly reduced by E/DRSP but not by T (HFA-E 70±5,6% vs HFD-E 41±4,5%, p<0,001). In conclusion, the present study shows that the association of Estradiol and Drospirenone as hormonal replacement therapy significantly improves vascular parameters and the composition of sera relevant for vascular protection in early post-menopausal normotensive women. These effects are not shared by Tibolone.


Assuntos
Androstenos/uso terapêutico , Endotélio Vascular/efeitos dos fármacos , Hemodinâmica/efeitos dos fármacos , Antagonistas de Receptores de Mineralocorticoides/uso terapêutico , Norpregnenos/uso terapêutico , Pós-Menopausa/efeitos dos fármacos , Determinação da Pressão Arterial , Doenças Cardiovasculares/prevenção & controle , Células Cultivadas , Método Duplo-Cego , Combinação de Medicamentos , Células Endoteliais/efeitos dos fármacos , Células Endoteliais/fisiologia , Endotélio Vascular/fisiologia , Estradiol/uso terapêutico , Feminino , Terapia de Reposição Hormonal/métodos , Humanos , Hipertensão/prevenção & controle , Pessoa de Meia-Idade , Pós-Menopausa/fisiologia , Progestinas/uso terapêutico , Análise de Onda de Pulso , Valores de Referência , Resultado do Tratamento
19.
Trials ; 17(1): 462, 2016 Sep 22.
Artigo em Inglês | MEDLINE | ID: mdl-27659741

RESUMO

BACKGROUND: Chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) frequently coexist, significantly reducing patients' quality of life and increasing morbidity and mortality. For either single disease, a multidisciplinary disease-management approach supported by telecommunication technologies offers the best outcome in terms of prolonged survival and reduced hospital readmissions. However, no data exist in patients with combined COPD/CHF. We planned a randomized controlled trial to investigate the feasibility and efficacy of an integrated, home-based, medical/nursing intervention plus a rehabilitation program versus conventional care in patients with coexisting COPD/CHF. The purpose of the paper is to describe the rationale and design of the trial. METHODS/DESIGNS: Patients, after inpatient rehabilitation, were randomly assigned to the intervention or control group, followed for 4 months at home, then assessed at 4 and 6 months. The intervention group followed a telesurveillance (telephone contacts by nurse and remote monitoring of cardiorespiratory parameters) and home-based rehabilitation program (at least three sessions/week of mini-ergometer exercises, callisthenic exercises and twice weekly pedometer-driven walking, plus telephone contacts by a physiotherapist). Telephone follow-up served to verify compliance to therapy, maintain exercise motivation, educate for early recognition of signs/symptoms, and verify the skills acquired. At baseline and 4 and 6 months, the 6-min Walk Test, dyspnea and fatigue at rest, oxygenation (PaO2/FiO2), physical activity profile (PASE questionnaire), and QoL (Minnesota and CAT questionnaires) were assessed. During the study, serious clinical events (hospitalizations or deaths) were recorded. DISCUSSION: Currently, no studies have assessed the impact of a telehealth program in patients with combined COPD and CHF. Our study will show whether this approach is effective in the management of such complex, frail patients who are at very high risk of exacerbations. TRIAL REGISTRATION: Network per la prevenzione e la sanità pubblica, CCM, Ministero della Salute "Modelli innovativi di gestione integrata telegestita ospedale-territorio del malato cronico a fenotipo complesso: studio di implementazione, validazione e impatto," registered on 14 January 2014. ClinicalTrials.gov Identifier: NCT02269618 , registered on 17 October 2014.

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