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Heart Failure clinical trials

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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: 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: NCT01999712 Suspended - Heart Failure Clinical Trials

Right Ventricular Failure After Implantation of Left Ventricular Assist Devices

Start date: July 2013
Phase: N/A
Study type: Observational

The left ventricular assist device (LVAD) is a portable mechanical pump that helps the left side of the heart of patients with severe heart failure that are awaiting heart transplantation or are not transplant candidates. However, while LVAD supports the left side of the heart, the right side must work on its own. Sometimes the right side does not recover, a condition called right ventricular failure (RVF). This complication increases mortality, prolongs hospitalization, requires additional procedures, and increases costs. Several risk factors and scores have been proposed to identify patients at risk for RVF. However, these methods have proven inadequate; one out of three patients is still experiencing right ventricular failure after LVAD surgery. Echocardiography, an established noninvasive method to see the heart without radiation or risk, has a lot of potential to identify patients at risk for RVF. The questions we will tray to answer with this American Heart Association funded project are: 1. Can echocardiography before scheduled LVAD surgery predict who is going to develop RVF and poor quality of life so we can better select patients for LVAD surgery? 2. Can echocardiography before scheduled LVAD surgery tell us the course of right ventricular function after implantation so we can potentially take additional measures and prevent RVF? To answer these questions, we will record images of the heart with echocardiography before LVAD surgery in 120 LVAD recipients at Emory University. We will then follow the patients for 90 days to detect any symptoms and signs of clinical RVF and poor quality of life and record the course of right ventricular function with echocardiography. Currently, it is estimated that 150,000 to 250,000 patients in US are potential LVAD recipients with 2,000 devices implanted in 2012. LVAD can improve survival and quality of life in suitable patients. However, implantation requires a major surgical procedure with associated risks and considerable resources. Thus, careful patient selection is necessary to minimize risk for patients and maximize benefit for patients and society. Our long-term goal is to use echocardiography as a tool to (1) optimally select patients for LVAD and offer alternatives to patients at increased risk for complications and (2) potentially, inform earlier LVAD implantation in patients with weakening right ventricular function.

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.

NCT ID: NCT01535196 Suspended - Clinical trials for Chronic Heart Failure

Vitamine D Treatment in Chronic Heart Failure

Start date: December 2012
Phase: Phase 3
Study type: Interventional

The investigators hypothesized that in vitamin D deficiency the 25-OH-D3 vitamin substitution improve the heart function in chronic heart failure. Type of study: Controlled, randomized, double blind, placebo control Number of patient: 300; 150 treated and 150 placebo controlled Type of drug: 180 000 IU 25-OH-D3 vitamin oil (Vigantol) per month in the 0,1,2,3,6, month Duration of study:1+1 year Primary end points: Survival rate, Ejection fraction by ultrasound, Brain natriuretic peptid, Secondary end points: Safety of D-vitamin supplementation, well being score, blood pressure, BMI Walking distant in 6 minutes Visits: Screening, Randomization, 1month, 2 month, 3 month, 6 month, 12 month, 24 month,

NCT ID: NCT01375335 Suspended - Heart Failure Clinical Trials

The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement

Start date: June 2011
Phase: Phase 4
Study type: Interventional

The use of dobutamine in postoperative hemodynamic treatment is widespread despite seemingly intact contraction of the heart. This study aims to elucidate the efficacy of low-dose dobutamine infusion in patients in the postoperative phase replacement of the aortic valve.