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Heart Failure clinical trials

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NCT ID: NCT03034551 Suspended - Heart Failure Clinical Trials

Mobile App With Patient Financial Incentives for Adherence to Heart Failure Medications & Daily Self-Weighing

Start date: January 30, 2017
Phase: N/A
Study type: Interventional

The goal of this study is to test the efficacy of a financial incentives-based telehealth intervention to reduce 30- and 90-day heart failure (HF) readmissions by tracking and increasing adherence to patient self-care - specifically by incentivizing adherence to prescribed cardiac medication regimen and daily self-weighing. Patients randomized to the treatment arm will be given a cellular-connected scale to use at home, as well as a mobile app on their smartphone that tracks their adherence to daily self-weighing through the scale and cardiac medications via patient photo submission. The health care team will intervene if a sudden increase in weight is detected (2 lbs/day or 5 lbs/week). Financial incentives of $150 are offered for full adherence over 90 days. Each day where the patient does not step on the scale and complete a medication check-in will result in a deduction of $2 per day from the incentive amount to be paid out. The control group will receive the usual discharge instructions as prescribed by their health care team.

NCT ID: NCT03001141 Suspended - Clinical trials for Heart Failure, Unspecified

Study Protocol/ Registry of MultiPoint™ Pacing in Brazil

Start date: May 18, 2017
Phase: N/A
Study type: Observational [Patient Registry]

This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 200 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 10 centers.

NCT ID: NCT02997670 Suspended - Clinical trials for Heart Failure, Systolic

Quartet Lead With Defibrillator Multisite Algorithmic Cardiac Resynchronisation Therapy Optimisation

QUARTRMASTER
Start date: September 2018
Phase: N/A
Study type: Interventional

Cardiac resynchronisation therapy (CRT) improves outcomes and symptoms in selected patients with heart failure. However, around one third of suitable patients do not demonstrate benefit following device implantation when assessed by echocardiography (heart scanning). This group has poorer outcomes. Response rate can be enhanced by altering timing delays between the pacing leads, but some patients still fail to improve. Quadripolar left ventricular leads are now widely used in CRT. The lead's four poles increase the number of conformations available to the programmer, allowing multiple vectors to be programmed simultaneously or sequentially. This allows programming to avoid, for example, a patch of scar and find an area that will respond better to pacing. This technique is known as multi-site pacing. CRT is often implanted along with a defibrillator lead in the right ventricle, known as CRT-D. The defibrillator lead offers further combinations for pacing. Goal of Research To evaluate an algorithm for assessing different multi-site pacing combinations in optimisation of CRT Outline The investigators will recruit 24 consecutive patients undergoing CRT-D implantation for conventional indications at our hospital. At baseline, patients will undergo echocardiography, exercise testing and assessments of functional ability and quality of life. The device will be implanted as standard. Optimisation will be performed with an algorithm using different vector combinations and assessing the heart's efficiency through echocardiography and invasive pressure monitoring. The pacemaker will be programmed with standard settings. After twelve weeks, the baseline investigations and optimisation algorithm will be repeated and the device programmed according to the maximum efficiency. After a further 12 weeks, the same parameters will be measured to look for improved response to CRT. Potential Benefit To increase the response rate to cardiac resynchronisation therapy and improve reliability of the technique

NCT ID: NCT02662439 Suspended - Heart Failure Clinical Trials

Bioimpedance Analysis in Chronic Heart Failure

Start date: February 2016
Phase: N/A
Study type: Interventional

The aim of this study is to investigate whether the objective measurement of fluid overload by bioimpedance analysis (Body Composition Monitor-BCM) in patient with acute decompensated heart failure would improve the diuretic therapy.

NCT ID: NCT02656329 Suspended - Heart Failure Clinical Trials

International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device

ADMIRE-ICD
Start date: January 2016
Phase: Phase 3
Study type: Interventional

This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in New York Health Association (NYHA) class II and III heart failure patients with 25%≤left ventricular ejection fraction (LVEF)≤35%, and in particular, for identifying patients who are at low risk for sudden cardiac death and who would not benefit, or may suffer harm, from implantation of an ICD device.

NCT ID: NCT02545582 Suspended - Clinical trials for Congestive Heart Failure

VITARIA Registry Study

Start date: August 2015
Phase: N/A
Study type: Observational [Patient Registry]

This registry will observe patients with symptomatic heart failure with implantable vagus nerve stimulation to provide insights into safety and efficacy during clinical routine.

NCT ID: NCT02501811 Suspended - Clinical trials for Ischemic Cardiomyopathy

Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure

CONCERT-HF
Start date: October 2015
Phase: Phase 2
Study type: Interventional

This is a phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cardiac stem cells (CSCs) both alone and in combination (Combo), compared to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by transendocardial injection in subjects with ischemic cardiomyopathy.

NCT ID: NCT02440971 Suspended - Clinical trials for Sleep Disordered Breathing

Adaptive Servo Ventilation (ASV) in Heart Failure

Start date: May 2013
Phase:
Study type: Observational

Up to 60% of patients with heart failure show abnormal patterns of breathing (sleep disordered breathing (SDB)) at night which can increase the risk of recurrent admissions and have important prognostic implications. SDB is however, treatable with the use of non invasive breathing support devices such as the adaptive servo ventilation (ASV) device. The aim of the study is to observe and investigate the potential role of ASV in the management of heart failure. Patients that agree to participate in this study will be requested to use an ASV ventilator device (called the AutoSet CS-A) to help their SDB for approximately 6 weeks. The device is approximately the size of a large shoe box, which can be placed at the side of the bed, with tubing and a mask. At night, the mask is placed over the nose and/or mouth and it blows positive air pressure as determined by the device itself as it constantly monitors the patients breathing throughout the night. During this study, the patients breathing patterns will be monitored non-invasively using the ApneaLink device. A non-contact device knows as a SleepMinder will sit on the patients bedside locker as another form of monitoring of their sleep patterns. Study staff will monitor the patient and give them frequent support, and they will also be asked questions regarding their experiences with this equipment and any symptoms they may have over this time. They will be followed up regarding this study at the same time as their follow-up requirements for their heart failure. This study will be conducted in total over 3 months.

NCT ID: NCT02203383 Suspended - Heart Failure Clinical Trials

The Effect of CRT on the Hypercapnic Ventilatory Response

Start date: June 2014
Phase: N/A
Study type: Observational

Central Sleep Apnoea (CSA) affects up to half of patients with severe heart failure and is associated with a poor prognosis. CSA is manifest as episodes of deep breathing interspersed with very shallow or absent breathing and is largely due to an exaggerated response to rising carbon dioxide in the blood, which normally drives how hard we breathe. Cardiac Resynchronization therapy (CRT), in which a pacemaker is implanted to improve co-ordinated contraction of the heart, has been shown to reduce the severity of CSA in some patient groups. We aim to determine whether this improvement is due to normalization of the body's response to carbon dioxide in the blood. Our hypothesis is that CRT improves CSA by normalizing the brain's response to carbon dioxide.

NCT ID: NCT01868880 Suspended - Clinical trials for Heart Rate Control in ICD Patients With Heart Failure

Effect of Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Right Ventricular Pacing

Start date: February 2016
Phase: Phase 4
Study type: Interventional

The aim of this prospective, randomized and controlled trial is to evaluate the use of the ivabradine in combination to a low-dose of beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) to obtain heart rate (HR) control with reduction in RV pacing in single-chamber or dual chambers ICD recipients HF patients with moderate to severe left ventricular dysfunction (FE ≤ 40%) and an heart rate ≥ 70 bpm in sinus rhythm over a 12-months follow up. Besides the investigators want to assess if the combination of ivabradine to a low-dose of beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) may determine a lower degree of left ventricular dysfunction progression, the reduction of ventricular arrhythmias burden and ICD appropriate therapy occurrence and the improvement of quality of life in ICD heart failure patients.