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NCT01640769
This randomized controlled trial will assess a cardiac MRI derived 4D digital cardiac model to optimized left and right ventricular lead delivery to improve response to cardiac resynchronization therapy.
NCT04589065
The purpose of this clinical trial is to see if a new device (SCD) is safe and if it can reduce damage to the kidney enough to allow medications to work to improve heart and kidney function for use in patients that have moderate to severe heart failure and is at least in part due to heart failure and it not responding to standard medical therapy. The SCD is a cartridge used with a commercial hemodialysis unit. Participants will be enrolled in the clinical trial once eligibility is confirmed. In addition to clinical assessments and laboratory testing participants will have surface echocardiograms during the trial. The SCD treatment will take place for 4 hours on day 1, 3, and 5 while on hemodialysis.
NCT01347567
The purpose of this study is to determine if heart failure subjects whose treatment is assisted by home BNP measurements integrated into a home health management system will have better clinical outcomes than subjects whose treatment includes home health management without BNP or than subjects treated by standard care.
NCT01765400
The investigators aim to determine if patients with systolic heart failure treated with prasugrel achieve greater platelet inhibition compared to those treated with clopidogrel.
NCT03984591
Objective The objective is to compare the efficacy of spironolactone and eplerenone on clinical outcome in patients with heart failure and a reduced ejection fraction. Method The study is a crossover cluster randomized trial. Each heart failure clinic in Denmark will be allocated to four periods (clusters): two periods with spironolactone and two periods with eplerenone as first drug. The planned total participation time for each department is 4 years and we estimate that data from 7200 patients will be accrued in this period. Endpoints will be assessed through Danish National Registries.
NCT03755570
The primary objective of COGNI-CRT is to assess whether Cardiac Resynchronisation Therapy (CRT) can improve cognitive function in patients with systolic HF (LVEF ≤35%), when compared to a control group of patients implanted with an Implantable Cardioverter-Defibrillator (ICD) or a permanent pacemaker (PPM) with systolic HF (LVEF ≤35%). This clinical investigation is a prospective, single-centre cohort study. Each participant will be followed for 6 months. The study will collect data over 3 years; 2.5 years for enrolment and 6 months until the last participant completes the last 6-month follow-up visit. N.B: COGNI-CRT does NOT affect the patient's care pathway - the patients who will be selected for participation are those who have already been referred for the device implant. The ONLY difference to the patient's care pathway caused by COGNI-CRT is the addition of a battery of cognitive function tests, which involves asking the patient questions and asking them to complete questionnaire-like cognitive tests. NTpro-BNP levels, NYHA classification and LVEF will be measured prior to device implantation and at 6-months post-implant to assess the device's impact on the participant's heart failure (and CRT response). N.B: NT-proBNP, NYHA classification and LVEF are all parts of the patient's standard care pathway, COGNI-CRT is just utilising the data collected as part of the investigation. The main study arm and control group allows COGNI-CRT to assess 3 potential outcomes for patients with severe HF (LVEF \<35%): 1. Cognitive function is not improved by CRT, ICDs or PPMs 2. Cognitive function can be improved by the assurance of rate control offered by CRT, ICDs and PPMs 3. Cognitive function can be improved by the assurance of ventricular synchronisation and rate control provided by the additional left ventricular lead in CRT devices.
NCT04065893
Cardiac resynchronization therapy reduces mortality in patients with systolic heart failure and left bundle branch block. Reduced biventricular pacing can lead to therapy failure. Most effective mortality reduction was seen with a BiV pacing above 98%. Reduced BiV pacing is a common phenomenon with potential impact on CRT-response and pts' prognosis. Frequent ventricular ectopy may be associated with attenuated benefit from CRT. The investigators sought to systematically assess the effect of ventricular arrhythmia treatment on BiV pacing.
NCT02958098
The My Research Legacy Pilot Study will establish a participant registry that collects self-reported health data and answers to online survey questions about individual daily choices, diets, and exercise; data from wearable devices; and, (optional) data from genome sequencing analysis. Individuals under the age of 50 who meet eligibility criteria will answer questions using the American Heart Association's (AHA) Life's Simple 7™ My Life Check v4.0 three times over the course of 6 months and transmit data from a Fitbit Charge 2 device. All other individuals who are interested in the study and meet entry criteria may also enroll.
NCT02026102
The purpose of this study is to test the acceptability and feasibility of a "toolkit" of patient decision aids (PtDAs) for heart failure patients who are considering an ICD implant.
NCT03871699
In general, anemia is associated with a greater presence of HF symptoms, worsening NYHA functional class, higher rate of hospitalization for heart failure, and reduced survival. However, it is unclear whether anemia is the cause of decreased survival or a marker for more advanced disease. Correction of iron deficiency in patients with New York Heart Association (NYHA) class II or III HF using intravenous iron (Ferinject®) improved "overall patient self-assessment" and NYHA functional class of 6-minute walk and health-related quality of life) in the FAIR-HF trial. It is unknown if iron deficiency is correlated with intra-myocardial iron load as assessed by cardiac magnetic resonance (CMR) and if the treatment with intravenous iron has any impact on intra-myocardial iron load and left ventricular function. The aim of the present study is to evaluate the effect of intravenous iron replacement on intra-myocardial iron deposits and the effect on left ventricular function. Because it is a pilot study with few data in the literature, it is planned to use an initial sample of 20 patients. We aim to evaluate the global ventricular function, the iron load by the T2 \* method, the cardiac strain, the "Fiddle" and the "Fat water" of each patient by CMR. After this examination, patients will undergo intravenous infusion of 1g of Ferric Carboxymaltose (Ferinject®). A comparative analysis of the ejection fraction values at the beginning and at the end of the study by CMR will be performed, in addition to a clinical reassessment. The inclusion criteria will be: Patients older than 18 years, with iron deficiency and reduced ejection fraction defined as: serum ferritin \<100 μg / L or with ferritin 100-299 μg / L with transferrin saturation \<20 %; Hemoglobin \<12g / dL in women and \<13g / dL in men; Clinical stability in the last 3 months; Left ventricular ejection fraction (LVEF) \<40% assessed by transthoracic echocardiography or CMR in the last 3 months. The exclusion criteria will be: patients with preserved ejection fraction (\> 50%), pregnant women, refusal to participate in the present study, implantable pacemaker or implantable defibrillator incompatible with MRI, cerebral cerebral aneurysm clip and/or intracerebral or intraocular metal fragments, electronic cochlear implants, patients with claustrophobia, patients with clinical or hemodynamic instability and patients with indication for blood transfusion (Hb ≤ 7g / dL).
NCT03764722
Rehospitalizations due to exacerbation of chronic heart failure are an important problem for patients suffering from heart failure. Rehospitalzations lead to worse prognosis, have an impact on the quality of life and have a negative financial impact on the health care system. Currently, studies are being conducted on the efficacy of levosimendan in the prevention of heart failure exacerbations. Patients receive levosimendan at repetitive use and preliminary results suggest a reduction in the incidence of exacerbations of heart failure. Thanks to the clinical trial planned in the Department of Cardiology of the Biziel Hospital with repeatable use of levosimendan, it is possible to determine the benefits of this method of treatment more accurately.
NCT03504891
This study will investigate the use of cardiac MRI in patients with standard ICDs and pacemakers to inform how cardiac resynchronization therapy (CRT) can best be implemented in these patient and which patients are the best candidates for CRT.
NCT01639378
The REACH study, is a prospective, double-blinded, randomised, controlled study of the safety and effectiveness of renal denervation in subjects with chronic systolic heart failure. Bilateral denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radio frequency (RF) energy through the luminal surface of the renal artery.
NCT00709241
This prospective observational study is designed to confirm the prognostic and economic impact of depression in ambulatory patients with systolic or diastolic heart failure, to explore the impact of other psychosocial patterns such as type D personality, anxiety disorders, locus of control, perceived social support, anger, hopelessness, and to evaluate potential pathophysiological and behavioral pathways.
NCT02223403
Nitrate-rich beetroot juice supplementation has demonstrated reduced oxygen consumption and submaximal exercise performance in healthy adults. Investigation for similar effects in patients with heart failure has not previously been conducted. This was a randomized, double-blind, placebo controlled trial. Following ingestion of the active agent or placebo, subjects with systolic heart failure underwent submaximal steady state exercise with gas exchange analysis followed thirty minutes later by a six minute walk test. Second testing sessions were performed ten days. There were no significant differences in the treatment and placebo arms in average oxygen consumption or six minute walk distance. In conclusion, in patients with heart failure who have ingested a single dose of nitrate-rich beetroot juice concentrate, there is no significant difference with regard to oxygen consumption during submaximal steady state exercise or six minute walk testing distance. Further study is warranted to determine the true efficacy of nitrate consumption in this population with adjustments in acute or chronic dosing, exercise duration, or intensity.
NCT01139697
The purpose of this study is to determine whether hair cortisol and testosterone levels correlate with heart failure status in patient with chronic congestive heart failure.
NCT01127334
Out of all the patients that receive a CRT-D ( a dual chamber pacemaker with defibrillator ) for cardiac resynchronization therapy there is approximately one-third that do not respond. We believe that by using a simple technique that includes routine echocardiography that are normally performed in these patients could help us better understand how to program their device to reach better optimization.
NCT01224899
The investigators sought to evaluate the feasibility and safety of surgical sympathetic blockade in systolic heart failure patients and secondary to assess its cardiovascular consequences.