Active clinical trials for "Heart Failure"

Background. Clinical benefits of cardiac resynchronization therapy (CRT) have been clearly demonstrated in heart failure (HF) patients with severe left ventricular (LV) dysfunction and wide QRS at surface electrocardiogram. However, there is a growing evidence that QRS duration poorly predicts responses to CRT, and that ~30% of patients do not experience any benefit from CRT when pre-implant dyssynchrony is defined according to electrocardiographic criteria. A number of echocardiographic criteria have been proposed to assess mechanical LV dyssynchrony, but at present there is no consensus on their use to predict response to CRT. Study Design. The Italian Multicenter PROject on echo assessment of left VEntricular (IMPROVE) dyssynchrony study is a prospective, multicenter, observational study aimed to assess feasibility and predictive power of mechanical dyssynchrony assessed by echocardiography in consecutive consenting patients candidate to CRT by clinical and electrocardiographic criteria. IMPROVE will enroll 120 healthy subjects and 216 HF patients in 6 sites in Italy. CRT response criteria will be based on improvement in NYHA class and LV reverse remodeling evaluated by 3D-echocardiography. Enrollment is expected to conclude early 2009. Implications. CRT is today part of the therapeutic armamentarium for symptomatic HF patients refractory to medical therapy, with wide QRS complex and severe LV systolic dysfunction. The IMPROVE study has been designed to evaluate reference values of indexes of ultrasound mechanical dyssynchrony that have been proposed in the literature and compare their ability to predict response to CRT in HF patients.

The ADOPT study is a prospective, nested case-controlled and open label clinical trial. About 40 centers across China participate in this study with a planned 800 Chinese cases enrollment. All patients will receive optimal medical treatment. Patients who have successful CRT-P/D implant will be assigned to CRT group. According to the baseline evaluation, matched cases will be selected from the enrolled OPT(optimal medical treatment) alone group (Group for Selection). After successful match, the cases in Group for Selection enters into follow-up and become control group. The unmatched cases in the Group for Selection will be removed. If patients agree, after re-evaluation of the baseline situation, she or he may enter into Group for Selection again. Since patients know she/he already have a device implant and the examiners are aware of the grouping of the patients after seeing the incision scar and post-implant electrocardiogram, this study is open-label designed, however the executive committee will be kept blind when making event-adjudication. Prospectively defined primary end points for the study include combined all-cause mortality and hospitalizations. A variety of secondary end points will further define the efficacy and mechanism(s) of action of cardiac resynchronization in heart failure. The last date of the study shall be the day after 24 months of follow-up of the last enrolled patient. All cases collection complete in 2010 and study result will be reported in 2012.

Only few prospective studies systematically investigated the prevalence of sleep disordered breathing in patients with stable chronic heart failure. Furthermore there is no report on the incidence rate of sleep disordered breathing in this population. This is a prospective multi-centre study of sleep-disordered breathing in 200 patients with stable moderate-to-severe chronic heart failure. Eligible patients will undergo overnight full-night polysomnography, lung function testing, laboratory measurements, and hemodynamic recordings. Measurements will be repeated at 6 months interval for a follow-up period of two years irrespective of the presence or absence of sleep disordered breathing. The primary outcome variable for this study is the prevalence of sleep disordered breathing in the study population. Secondary outcome variables include the 2-year incidence rate of sleep disordered breathing, quality of life measurements, exercise capacity, sleep quality, hemodynamic measurements, and laboratory markers of neurohumoral activation, systemic inflammation, and endothelial function in the study population.

Patients are part of a family network. When any person in a family becomes critically unwell and requires the assistance of an Intensive Care Unit (ICU), this has an impact on all members of that family. COVID-19 changed visiting for all patients in hospitals across Scotland. It is not known what effect these restrictions will have on patients' recovery, nor do we understand the impact it may have on their relatives or staff caring for them. This study will look at the implications of the visiting restrictions as a consequence of the COVID-19 pandemic upon patients without COVID-19 who are in the cardiothoracic ICU. It will also explore the impact of these restrictions on them, their relatives and staff. This study will be carried out within a single specialised intensive care unit in Scotland using mixed methods. The first arm of this study will use retrospective data that is routinely collected in normal clinical practice. The investigators will compare patient outcomes prior to COVID-19 with outcomes following the implementation of COVID-19 visiting restrictions. The aim is to establish if the restrictions on visiting has an impact on the duration of delirium. Delirium is an acute mental confusion and is associated with longer hospital stays and worse outcomes in this patient group. The second arm of this study involves semi-structured interviews with patients, relatives and staff that will allow deeper exploration of the issues around current visiting policy. The interviews will last approximately 1 hour and will address these issues. They will then be transcribed word for word and analysed using grounded theory, meaning the theories will develop from the data as it is analysed.

The study is a multi-center, prospective, non-randomized, observational study to collect data to develop and validate a machine learning algorithm for early detection of worsening heart failure events using multi-parametric sensor data from wearable data capture device The VESTA study will enroll up to 552 subjects in up to 25 centers in order to collect data on a total of at least 56 worsening heart failure events (independently adjudicated hospitalizations or unscheduled intravenous administration of decongestive drugs).The duration of follow-up per participant will be between 3-6 months.

Acute heart failure (AHF) is one of the most common causes of hospitalization and life-threatening medical condition around worldwide. The AHF patients admitted to the intensive care unit (ICU) usually be critically ill with multiorgan failure, in which the kidneys are most frequently involved. The goals of treatment of AHF in ICU were to improve hemodynamic stability and organ perfusion, alleviate symptoms, and limit cardiac and renal damage, which can be achieved by continuous renal replacement therapy (CRRT), a continuous extracorporeal blood purification. CRRT can mimic urine output to slowly and continuously remove patient's plasma water, providing accurate volume control and hemodynamic stability. Acute Heart Failure Global Survey of Standard Treatment (ALARM-HF) study showed that hospital mortality of AHF patients was about 17.8% in the intensive care unit (ICU). But the patients undergoing CRRT, the mortality up to 45%-62.1%. For this reason, an early model or score to a screening of AHF patients undergoing CRRT who at high mortality risk is crucial, which can help clinicians to rapidly intervene and ameliorate disease outcomes. The most popular tools, especially that can predict mortality for critically ill patients, are the Acute Physiology Assessment and Chronic Health Evaluation II (APACHE II) scoring systems, and Simplified Acute Physiologic Score II (SAPS II). But variables in these scoring systems are complex, which was not convenient to assess at any time. Modified Early Warning Score (MEWS) , much more concise than APACHE II and SAPS II, not only can be used for early warning of the onset of AHF in patients with the risk of heart failure but also has a positive correlation with mortality in these patients. However, up to our knowledge, there was no scores or model to predict the in-hospital mortality of AHF patient undergoing CRRT. Based on the acute heart failure unit (AHFU) of Qilu Hospital and the medical information mart for intensive care III (MIMIC III) database, the investigators collected the data of AHF adults undergoing CRRT. The present study aimed to develop and validate a simple-to-use nomogram model comprised of independent prognostic variables for predicting in-hospital mortality in AHF adults undergoing CRRT by using multivariate logistic regression analysis. With this model, the investigators can guide the early screening of high-risk patients in in-hospital mortality.

This is prospective cohort study with the purpose of improving our understanding of morbidity and mortality risk in patients with heart failure and chronic kidney disease.

Patients with unexplained stress dyspnea ( ≥ stage 2 NYHA), no significant underlying lung disease, with an ejection fraction > 50%, normal resting filling pressures, NTproBNP < 220 pg/ml in < 75 years, and < 450 pg/ml in ≥ 75 years will be studied with stress echocardiography and cardiometabolic stress test (VO2). These patients may have abnormal adaptation during exercise, suggesting that chronic symptoms may be related to a heart failure with preserved ejection fraction (HFPEF). More accurate and earlier diagnosis of HFPEF using stress echocardiography and VO2 may better manage stress dyspnea in patients and prevent progression of HFPEF. A clinical assessment will be offered to people with unexplained stress dyspnea. The procedures and products used in this study are usually used as part of HFpEF's diagnostic strategy. During this assessment, carried out on an outpatient basis, an anamnesis collection, a cardiovascular clinical examination, an evaluation of dyspnea by the NYHA functional class and by 2 questionnaires, an electrocardiogram will be carried out, a 6-minute walk test, a biological blood test, a trans thoracic rest and stress cardiac ultrasound, respiratory functional tests (with diffusion capacity of lung for carbon monoxide (DLCO) and blood gas), and a metabolic stress test. A follow-up at 1 and 2 years is planned (visit, sampling and resting echocardiography).

Part 1 (POC Precision): Objective : Demonstrate that the Minicare BNP (im)precision in hands of the user is within the expected range of the Minicare BNP (im)precision. Part 2 (sample comparison) Primary objective : Compare Minicare BNP values from capillary whole blood from finger stick with EDTA whole blood from venous puncture. Secondary objective : Compare Minicare BNP values from EDTA whole blood and plasma with Li- Heparin whole blood and plasma from venous puncture.

Respiratory monitoring during right heart catheterization to differentiate between various types of pulmonary hypertension; The effects of the cardiovascular system on the lung mechanical properties.