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NCT05560737
INTRODUCTION Psychological distress and reduced quality of life are prevalent in patients with chronic heart failure (CHF) and advanced chronic kidney disease (CKD). In addition, persons with CHF or CKD live with increased risk of primary or secondary complications associated with COVID-19, including mortality. International task force committees report that medical therapy combined with counselling for CHF and CKD self-care optimizes clinical outcomes. Digital health initiatives present an effective solution in light of the recent issue of declining patient attendance in essential outpatient appointments due to the increased risk of COVID-19 exposure. HYPOTHESES At study completion (up to 16 months), it is hypothesized that there will be a significant increase from baseline in the proportion of participants with clinically improved or sustained positive mental health. Additionally, greater engagement with the ODYSSEE-vCHAT program is expected to be linked with improved self-reported health- and wellbeing-related outcomes at months 4 and 8 and study completion (up to 16 months). RECRUITMENT Patients with CHF or CKD who are at least 18 years old were recruited from the University Health Network (UHN), Sunnybrook Hospital, Mount Sinai Hospital, The Ottawa Hospital, and the community. Accrual of the sample (N = 215) occurred over a 14-month period. DESIGN This is a single group, open label, pre-post study with assessments at baseline, months 4 and 8, and study completion (up to 16 months). ODYSSEE-vCHAT contacted subjects each week inviting them to participate or partake in digital counselling resources, chatrooms, and presentations with group discussions. Participation in supplemental mental health programs was monitored by self-report. ANALYSES A binomial logistic regression will evaluate if there is a greater proportion of participants with positive mental health at study completion. This analysis will assess if the proportion of participants with positive mental health at study completion (up to 16 months) is independently associated with ODYSSEE-vCHAT engagement (login minutes). General linear models will test secondary outcomes, adjusting for baseline assessments and potential covariates. Significance in all tests will be p \< 0.05, 2-sided. Any unplanned analyses will be adjusted for using the Bonferroni procedure.
NCT05102903
To evaluate the pharmacokinetic properties and safety of "BR1016A" and "BR1016B" in healthy adults.
NCT05873920
Single center prospective study to analyze the impact of diabetes mellitus on patients' outcome following radiofrequency-guided catheter ablation for atrial fibrillation.
NCT05102266
To evaluate the pharmacokinetic properties and safety of "BR1016C" and "BR1016D" in healthy adults.
NCT03038360
CardioSAVE is a prospective 12-month controlled longitudinal study for the validation of a novel predictive model and a diagnostic tool, for the risk stratification of AMI patients undergoing PCI, with a one year follow-up.
NCT05590780
The purpose of this study was to examine the association between circulating cfDNA concentration and CVD risk in patients with periodontitis, CVD, and periodontitis plus CVD. In addition, the secondary objective was to identify, among other confounders, the impact of periodontitis and cardiovascular disease as potential significant predictors of circulating cfDNA levels in the enrolled population.
NCT05871138
prognostic value of delta LUS score of patients hospitalized for acute heart failure within 30 days of discharge.
NCT05867394
It aimed to examine stress, anxiety and resorting to life paths to enable researchers to contain this stress.
NCT04151628
The study design is a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting.
NCT03823911
This is an interventional, non-randomized, controlled prospective study to treat HCV in mono-infected and HIV co-infected individuals and compare cardiovascular risk outcomes to HIV mono-infected controls. This pilot study will demonstrate whether functional cure of HCV reduces myocardial injury and risk of cardiovascular disease.
NCT05366400
Right ventricular (RV) dysfunction is associated with increased morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD). Assessment of RV function by echocardiography is challenging. Easy visualization of the right atrium (RA) by echocardiography , allows quantitative, highly reproducible assessment of RA volume. The aim of the present study is to evaluate the relationship between the right atrial volume index (RAVI) and functional capacity in patients with COPD , quantified by the COPD assessment test (CAT) questionnaire as an early predictor of right heart affection.
NCT05866497
Studies were found that a significant relationship between the severe periodontitis and increased CAVI values. While the exact mechanisms linking periodontitis, type 2 diabetes, and cardiovascular disease are not yet fully understood, it is clear that these diseases are interconnected. There are limited data in the literature evaluating the risk of atherosclerosis in diabetic individuals with periodontal disease. In our survey, we hypothesised that severe periodontitis may be a risk factor for the development of subclinical atherosclerosis among people with type 2 diabetes. Thus, we aimed to investigate the potential risk of subclinical atherosclerosis by using a new surrogate marker CAVI in severe periodontitis patients with short-term diabetes.
NCT04394754
The purpose of this study is to determine the efficacy of three novel digital health technologies versus usual care in the management of congestive heart failure, as assessed by a primary outcome of improvement in quality of life, and a variety of secondary outcomes that include metrics measuring patient and provider satisfaction, clinical efficiency, and patient outcomes.
NCT05865184
Sensorum Health (Sensorum) is conducting a pilot study to determine if Sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. Successful early detection would provide a window of opportunity to intervene outside of the acute setting in future interventional studies.
NCT05182788
To assess the efficacy evaluation of CHOLESWISE Pressed Candy on cardiovascular disease risk factors
NCT04147299
The primary objective of this research protocol is to advance the understanding of cardiopulmonary and right ventricular (RV) performance among individuals with cardiomyopathy (heart failure with reduced ejection fraction \[HFrEF\], heart failure with preserved ejection fraction \[HFpEF\]), as well as athletes engaging in endurance/prolonged exercise, who are at a high risk of an acquired cardiomyopathy during/following completion of an endurance event.
NCT05591365
To determine the effect of exercise training on cardiac outcomes in coronary artery disease patients after Stenting. There is a need to develop strategies, not only to prevent restenosis but also to improve patients' functional status and perception of well-being. In particular, it is not well defined whether exercise training can reduce the restenosis rate and improve the outcome after PCI.
NCT04649801
CASTLE-HTx will determine if AF ablation has beneficial effects on mortality in patients with end stage HF who are eligible for HTx
NCT04741711
AMBUSH study is a multicenter randomized, controlled, open-label clinical trial (PROBE (Prospective Randomized Open Blinded End-point) type). The main objective of AMBUSH study is to assess the effect of therapeutic management guided by pulmonary ultrasound and the assessment of the inferior vena cava in patients with heart failure seen in an ambulatory (outpatient) setting on a mixed clinical-biological endpoint (including variations of natriuretic peptides - NtProBNP) at 30 days.
NCT05859503
This study aims to compare the efficacy and safety of two strategies for closing large caliber venous access in patients undergoing percutaneous procedures: compression with figure-of-8 suture versus closure with the Perclose-Proglide system.