Efficacy and safety of beta-blockers and prolonged bronchodilators in patients with heart failure with coronary artery disease and moderate to severe COPD

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Evdokimov ◽  
E Yushchuk ◽  
A Evdokimova ◽  
S Ivanova ◽  
I Sadulaeva
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Condition ◽  
Blood Pressure Monitoring ◽  
Beta Blockers ◽  
Control Group ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Severe Copd

Abstract Purpose To compare clinical efficacy and safety of various treatment regimens with the inclusion of beta-blockers, RAAS antagonists (ACE inhibitors or ARBs), prolonged bronchodilators (LABA, LAMA) in heart failure patients with CAD and COPD. Methods 385 patients (292 men and 93 women), aged 66.3±4.1 years, with CHF classes II to III (NYHA) combined with moderate to severe COPD (GOLD) and with LVEF less than 45% were randomized into nine groups: enalapril + LAMA (control group), nebivolol + enalapril + LAMA, nebivolol + losartan + LAMA, nebivolol + losartan + LABA, nebivolol + losartan + LAMA/LABA, carvedilol + enalapril + LAMA, carvedilol + losartan + LAMA, carvedilol + losartan + LABA, carvedilol + losartan + LAMA/LABA. Patients of all groups received complex CHF treatment comprising diuretics, nitrates, cardiac glycosides (if necessary). Clinical examination, TTE, 6-minute walk test (6MWT), 24-hour electrocardiogram and blood pressure monitoring, respiratory function test were assessed at baseline and after 6 months of treatment. The quality of life was evaluated by MYHFQ, SGRQ and mMRC scale. Results After 6 months of therapy the improvement of clinical condition and quality of life were marked in all groups. At the end of observation period there was a significant improvement of patients clinical condition, quality of life, reduction of mean CHF FC and dyspnea severity, increase of exercise tolerance, slowing of progression of CHF and COPD, improvement of the parameters of intracardiac hemodynamics, structural and functional parameters of the left and right heart (a decrease in the size of the atria, LV volumes and internal dimension at end-diastole and end-systole, cardiac index, LVMMI, an increase of LVEF, a significant decrease in systemic vascular resistance and the pulmonary hypertension grade, significant improvement in systolic and diastolic function of the ventricles, regression of pathological remodeling of the heart, reduction of heart rate, duration and frequency of myocardial ischemia episodes (including its “silent” form). The best results were obtained in groups using a beta-blocker (nebivolol or carvedilol), a RAAS antagonist, and a combination of long-acting bronchodilators (indacaterol and tiotropium) – group 5 and 9. It is worth noting that beta-blockers, LABA and LAMA were well tolerated in all observation groups and serious adverse events were absent. Conclusions The appointment of 3-generation beta-blockers to patients with CHF on the background of CAD and COPD can significantly increase the effectiveness of treatment and does not cause a deterioration in spirometry in patients with such cardiopulmonary pathology. In our opinion, the most important point in the appointment of beta blockers to patients with moderate to severe COPD is low start dose and slow titration of the dose at the beginning of the therapy. It is advisable to include in the complex therapy of such patients a combination of LABA and LAMA as a basic bronchodilator support. Funding Acknowledgement Type of funding source: None

Coronary Stress Test as a Predictor of Quality of Life in Chronic Heart Failure Patients

2015 ◽  
Vol 69 (1) ◽  
pp. 26-29
Author(s):  
Borjanka Taneva ◽  
Dejan Ristevski
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Chronic Heart Failure ◽  
Conventional Therapy ◽  
Exercise Tolerance ◽  
Therapy Group ◽  
Beta Blockers ◽  
Control Group ◽  
Heart Failure Patients

Abstract Introduction. Exercise tolerance is one of the life quality parmeters in chronic heart failure patients. The aim of our study was to assess the quality of life of patients with chronic heart failure by estimating their exercise tolerance. Methods. We examined 113 patients with stable chronic heart failure in the period of 18 months. They were divided in two groups, a control group (on conventional therapy of angiotensin-converting enzyme inhibitors and diuretics) and a therapy group (conventional therapy plus beta-blockers). The therapy group was divided into 3 subgroups according to the beta-blocker taken (a Metoprolol Bisoprolol and Carvedilol subgroup). Exercise tolerance was detected by coronary trade-mill stress testing every 6 months (only in patients of NYHA FC II and III), symptoms limited or modified after 6-minutes Bruce test. Results. Our results showed that there was a statistically significant difference between the control group and all the therapy subgroups in NYHA FC, NYHA score and exercise tolerance at the end of the study, but there was no difference among the subgroups. Conclusion. Beta-blockers improve the exercise tolerance as a variable defining quality of life.

Long-term effectiveness of telephone-based health coaching for heart failure patients: A post-only randomised controlled trial

2016 ◽  
Vol 23 (8) ◽  
pp. 716-724 ◽  
Author(s):  
Michel Tiede ◽  
Sarah Dwinger ◽  
Lutz Herbarth ◽  
Martin Härter ◽  
Jörg Dirmaier
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Locus Of Control ◽  
Controlled Trial ◽  
Health Coaching ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Heart Failure Patients ◽  
Health Related

Introduction The * Equal contributors. health-status of heart failure patients can be improved to some extent by disease self-management. One method of developing such skills is telephone-based health coaching. However, the effects of telephone-based health coaching remain inconclusive. The aim of this study was to evaluate the effects of telephone-based health coaching for people with heart failure. Methods A total sample of 7186 patients with various chronic diseases was randomly assigned to either the coaching or the control group. Then 184 patients with heart failure were selected by International Classification of Diseases (ICD)-10 code for subgroup analysis. Data were collected at 24 and 48 months after the beginning of the coaching. The primary outcome was change in quality of life. Secondary outcomes were changes in depression and anxiety, health-related control beliefs, control preference, health risk behaviour and health-related behaviours. Statistical analyses included a per-protocol evaluation, employing analysis of variance and analysis of covariance (ANCOVA) as well as Mann-Whitney U tests. Results Participants’ average age was 73 years (standard deviation (SD) = 9) and the majority were women (52.8%). In ANCOVA analyses there were no significant differences between groups for the change in quality of life (QoL). However, the coaching group reported a significantly higher level of physical activity ( p = 0.03), lower intake of non-prescribed drugs ( p = 0.04) and lower levels of stress ( p = 0.02) than the control group. Mann-Whitney U tests showed a different external locus of control ( p = 0.014), and higher reduction in unhealthy nutrition ( p = 0.019), physical inactivity ( p = 0.004) and stress ( p = 0.028). Discussion Our results suggest that telephone-based health coaching has no effect on QoL, anxiety and depression of heart failure patients, but helps in improving certain risk behaviours and changes the locus of control to be more externalised.

An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial

Neurosurgery ◽  
2017 ◽  
Vol 83 (1) ◽  
pp. 146-153 ◽  
Author(s):  
Pierre-Yves Borius ◽  
Stéphanie Ranque Garnier ◽  
Karine Baumstarck ◽  
Frédéric Castinetti ◽  
Anne Donnet ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Relief ◽  
Cancer Pain ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Standards Of Care ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label

Abstract BACKGROUND Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. OBJECTIVE To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. METHODS The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. EXPECTED OUTCOMES We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. DISCUSSION The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life.

scholarly journals Minimally invasive combined surgical treatment of postcoital cystitis

2020 ◽  
Vol 21 (2) ◽  
pp. 20-25
Author(s):  
J. Sh. Inoyatov ◽  
O. V. Snurnitsyna ◽  
M. V. Lobanov ◽  
O. Yu. Malinina ◽  
Yu. L. Demidko ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Main Group ◽  
Control Group ◽  
Efficacy And Safety ◽  
Study Objective ◽  
Results Of Treatment ◽  
Main Disadvantage ◽  
Combined Technique ◽  
Treatment Profile

Introduction. Urethral transposition remains the most popular operation for postcoital cystitis, however, traumatism and complications, especially such as pudendal neuropathies, dyspareunia and anorgasmia, make us continue to search for effective, but safer techniques.The study objective is to evaluate the efficacy and safety of the proposed treatment of postcoital cystitis, including removal of urethrogymenal adhesions and subsequent paraurethral filler implantation, in comparison with isolated hymenoplasty.Materials and methods. Since 2013, 75 patients with postcoital cystitis have been treated. Patients were divided into two groups: main group – hymenoplasty (removal of urethral adhesions) with paraurethral filler implantation (n = 45), control group – hymenoplasty (n = 30). The gel was injected paraurethrically, fan-shaped, in the volume of 1–2 ml, from a point on the 6-hour conditional dial, creating a gel cushion and thus raising the meautus and distal urethra. To assess the quality of treatment, profile questionnaires were used.Results. In the main group of patient, the quality of life improved in 35 (78 %); in 5 patients, due to the process of biodegradation of the gel during 1 year, the cystitis recidivated, which required the filler reimplantation. In 5 patients, the operation was not effective. In the control group the efficiency of isolated hymenoplasty was noted in 3 (10 %) patients, relapse of cystitis occurred in 27 (90 %) patients, which later required the implantation of a filler. No complications were observed.Conclusions. The suggested combined technique allows to improve the results of treatment of patients with postcoital cystitis. The operation does not carry the risk of damage to the sprigs of the genital nerve, can serve as an alternative to traditional urethral transposition. The main disadvantage is the natural biodegradation of the gel, which may create the need for its reintroduction.

scholarly journals Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Hongyu Yue ◽  
Shuang Zhou ◽  
Huangan Wu ◽  
Xuan Yin ◽  
Shanshan Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Control Group ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Symptom Scale ◽  
Significance Level

Abstract Background Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. Method This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). All analyses will be based on ITT principle and performed with the statistical software SPSS (version 24.0) by t test, rank-sum test, chi-square, and so on. A two-sided significance level will be set at 5%. Discussion This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. Trial registration ChiCTR ChiCTR1900026395. Registered on 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068

scholarly journals Efficacy and Safety of PARACHUTE® Device: systematic review

2018 ◽  
Vol 64 (9) ◽  
pp. 853-860 ◽  
Author(s):  
Roberta da Silva Teixeira ◽  
Bruna Medeiros Gonçalves de Veras ◽  
Kátia Marie Simões e Senna ◽  
Rosângela Caetano
Keyword(s):  
Quality Of Life ◽  
Myocardial Infarction ◽  
Heart Failure ◽  
Systematic Review ◽  
Left Ventricular ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Frequent Event

SUMMARY INTRODUCTION Heart failure due to an acute myocardial infarction is a very frequent event, with a tendency to increase according to improvements in the treatment of acute conditions which have led to larger numbers of infarction survivors. OBJECTIVE The aim of this study is to synthesize the evidence, through a systematic review, on efficacy and safety of the device in patients with this basic condition. METHODS Studies published between January 2002 and October 2016 were analysed, having as reference databases Embase, Medline, Cochrane Library, Lilacs, Web of Science and Scopus. The selection of studies, data extraction and methodological quality assessment of studies were examined by two independent reviewers, with disagreements resolved by consensus. RESULTS Only prospective studies without control group were identified. Six studies were included, with averages of 34 participants and follow-up of 13 months. Clinical, functional, hemodynamic and quality of life outcomes were evaluated. The highest mortality rate was 8.4% with 12-month follow-up for unspecified cardiovascular reasons, and heart failure rehospitalization was 29.4% with 36-month follow-up. Statistically significant improvements were found only in some of the studies which evaluating changes in left ventricular volume indices, the distance measured by the six-minute walk test, New York Heart Association functional classification, and quality of life, in pre and post-procedure analysis. CONCLUSIONS The present review indicates that no available quality evidence can assert efficacy and safety of PARACHUTE® in the treatment of heart failure after apical or anterior wall myocardial infarction.

Exercise training and cardiac rehabilitation in patients with implantable cardioverter defibrillators: a review of current literature focusing on safety, effects of exercise training, and the psychological impact of programme participation

2011 ◽  
Vol 19 (4) ◽  
pp. 804-812 ◽  
Author(s):  
Kjetil Isaksen ◽  
Ingvild Margreta Morken ◽  
Peter Scott Munk ◽  
Alf Inge Larsen
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Exercise Training ◽  
Cardiac Rehabilitation ◽  
Current Literature ◽  
Control Group ◽  
Implantable Cardioverter Defibrillators ◽  
Increased Risk ◽  
Cardioverter Defibrillators

Background: Indications for implantable cardioverter defibrillators (ICDs) have been widened considerably during the last decade due to the well-documented effect in the heart failure population. Exercise training (ET) has a 1 A recommendation in heart failure. However, data on safety and efficacy of ET in patients with ICDs is sparse. ICD shocks are associated with reduced quality of life and increased mortality. Whether ET may have a beneficial effect in heart failure patients with an ICD is not well documented. Methods: This review is based on a systematic search in the Pub Med database using the terms ‘exercise training’, ‘implantable cardioverter defibrillator’, and ‘cardiac rehabilitation’. Results: Nine studies were identified, comprising 1889 patients. The average duration of exercise-based cardiac rehabilitation (CR) was 9.6 weeks. Ten ICD therapies (seven shocks) were reported in the 834 patients with ICD during ET. Between exercise sessions and during follow up 182 events were recorded including 166 shocks. Three studies (2 randomized) showed that the control group representing sedentary patients were more prone to ICD discharge than patients undergoing CR/ET. In all studies the ICD patients improved their aerobic fitness following ET. Few studies report data on the effect of ET on anxiety and depression. Conclusion: Based on the current literature, ET in patients with an ICD seems to be safe and is not associated with increased risk of shocks. ET improves aerobic capacity in ICD patients, while effects on anxiety, depression and quality of life are still under debate.

scholarly journals The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Tianye Hu ◽  
Hantong Hu ◽  
Feng Chen ◽  
Bin Jiang ◽  
Fengfei Shen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Outcome Measures ◽  
Vestibular Migraine ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.

scholarly journals Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial

JMIR Nursing ◽  
10.2196/20747 ◽  
2020 ◽  
Vol 3 (1) ◽  
pp. e20747
Author(s):  
Mahboube Davoudi ◽  
Tahereh Najafi Ghezeljeh ◽  
Farveh Vakilian Aghouee
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Patients With Heart Failure

Background Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. Objective The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. Methods This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. Results The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). Conclusions Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. Trial Registration Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

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