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Heart Failure clinical trials

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NCT ID: NCT02468232 Completed - Clinical trials for Heart Failure With Reduced Ejection Fraction (HF-rEF)

Study of Efficacy and Safety of LCZ696 in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction

PARALLEL-HF
Start date: June 15, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to assess the effect of LCZ696 at a target dose of 200 mg b.i.d. compared to enalapril 10 mg b.i.d., in addition to the background heart failure (HF) treatment, on delaying time to first occurrence of either cardiovascular (CV) death or HF hospitalization events in Japanese patients with stable chronic heart failure (CHF), New York Heart Association (NYHA) classes II-IV and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤ 35%).

NCT ID: NCT02467387 Completed - Clinical trials for Non-Ischemic Heart Failure

A Study to Assess the Effect of Intravenous Dose of (aMBMC) to Subjects With Non-ischemic Heart Failure

Start date: June 1, 2014
Phase: Phase 2
Study type: Interventional

A phase IIa study to assess the safety and preliminary efficacy of intravenous dose of ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells in subjects with non-ischemic heart failure.

NCT ID: NCT02467296 Completed - Heart Failure Clinical Trials

Dietary Sodium Intake and Outcomes in Heart Failure

PROHIBITSodium
Start date: February 2015
Phase: N/A
Study type: Interventional

Currently, the recommendations for sodium intake restriction for patients with heart failure are mostly based on expert consensus and observational evidence, whereas smaller randomized studies have actually suggested that strict dietary sodium reduction may be harmful in heart failure. In the present clinical trial pilot study, the investigators plan to collect data on enrollment rates, compliance, outcomes, and safety of a 12-week dietary intervention in heart failure patients, with prepared food containing two different levels of sodium (1,500 mg and 3,000 mg) daily, followed by a 12-week surveillance for safety and effectiveness. The goal is to inform the design of a fullscale clinical trial that will provide more definitive evidence for dietary sodium recommendations in heart failure.

NCT ID: NCT02466100 Completed - Heart Failure Clinical Trials

Goals of Care Communication

GoC
Start date: June 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This study proposes to evaluate, among adults with advanced heart failure (HF) and their health care providers, the effects of a communication intervention designed to improve patient-provider communication about goals of care (GoC). Patient activated GoC conversations can result in providers' better understanding their patients' preferences for end-of-life care. GoC conversations that occur over time may allow patients and providers to consider a wider range of options earlier in the HF illness trajectory. Preliminary data suggests that the proposed GoC intervention increases the occurrence and quality of patient-provider communication about end-of-life care for advanced COPD. The proposed study will test the effects of the GoC intervention compared to usual care, using a randomized, 2-group (N = 80, n = 40/arm), repeated-measures design. Measures will be taken at a patient's baseline study entry and after the next scheduled clinic visit. Specific Aim 1 is to evaluate change in number of GoC conversations between patient and provider between the two groups. Specific Aim 2 is to examine whether the intervention increases patient quality of life, referrals to palliative care, advance care planning, decreases depression and anxiety. Specific Aim 3 is to describe the feasibility, acceptability, perceived benefits, burden, and implementation success of the intervention in the heart failure clinic setting. Patients will be randomized to the GoC intervention or to receive usual care. Patients in the GoC intervention group, telephone coaching by a research nurse to help patients role-play talking with their HF providers. Both patients and their providers, will be provided with summaries of individualized, patient-centered information about patient preferences for communicating about end-of-life care and patient self-identified barriers to and facilitators of communication about end-of-life care with tips on how to initiate goals of care discussions. Providers of patients in the intervention group will also be provided with patient-specific prognostic information based on the Seattle Heart Failure Model. The GoC intervention will be tested in a real-world clinic setting. This intervention is expected to be relatively cost-effective and easily translated into general cardiology practice in the future. The study is expected to make significant contributions to provision of earlier access to palliative care in the advanced HF disease trajectory.

NCT ID: NCT02463903 Completed - Heart Failure Clinical Trials

Coping Effectiveness Training in Patients With Chronic Heart Failure

Start date: March 2011
Phase: N/A
Study type: Interventional

The purpose of the present study is to develop, implement and evaluate a stress management program aiming to improve emotional well-being, health-related quality of life and to reduce readmission to hospital in patients with chronic heart failure (CHF). Method: A randomized controlled study design will be employed in which the intervention consists of Coping Effectiveness Training (CET), a manual-based group intervention based on a cognitive transactional theory of stress and coping. The purpose of CET is to improve skills to appraise stress, teach a number of techniques to cope with stress, and to give an opportunity to interact with other people with similar experiences of living with CHF. The control group will receive standard health care. The intervention group will receive seven weekly sessions of CET. Self-assessments of; emotional well-being, depression and anxiety, illness perception, health-related quality of life, coping strategies and social support will be performed before the intervention, directly after the intervention, six weeks, six months and one year after the intervention period as well as measuring readmission to hospital. In addition, the participants in the intervention group will fill in an anonymous written evaluation, with closed and open ended questions, directly after the intervention.

NCT ID: NCT02463786 Completed - Clinical trials for Chronic Heart Failure

Improving Knowledge To Efficaciously RAise Level of Contemporary Treatment in Heart Failure (

INTERACTinHF
Start date: July 1, 2012
Phase:
Study type: Observational [Patient Registry]

Heart failure (HF) remains to have a poor outcome. Even though recent advances in HF led to a reduction of morbidity and mortality, improvement in outcome is much less than expected based on large randomized trials. Various reasons may be responsible, such as complexity of disease and comorbidities, inadequate diagnosis and inappropriate treatment. So far, little attention has been paid on patients seen in primary care. Also, HF care mainly focuses on the individual patient-doctor relationship. However, the increasing complexity prevents individual physicians from covering all aspects of care. Consequently, multiple stakeholders are involved, including both general practitioners and specialists. Still, the relative role, the interaction between them and the processes included are hardly defined. These aspects may not only be relevant for patient care, but also for the setup of health care systems. Whereas multidisciplinary team should resemble a seamless system across primary and hospital care, there is a scarcity of research considering how these disease management programs perform, in what form they should be offered, and what care and support patients and caregivers would benefit most.The INTERACT-in HF (Improving kNowldege Transfer to Efficaciously RAise level of Contemporary Treatment in Heart Failure) study is set up to determine and assess relevant factors of the quality of HF care. The study evaluates processes of HF care, role of relevant care givers and interactions between them. It collects data from individual patients to assess characteristics and management of contemporary HF patients. This is performed in different countries (the Netherlands, Belgium and Germany) to analyze decision making with respect to diagnostics and treatment.Cross-sectional mixed-methods are used. Patients and their caregivers are interviewed. The patient is the central starting point. Then, the treating GP, cardiologist and HF nurse are interviewed. In parallel, retrospective data based on records from these patients are reviewed to verify data from interviews and to determine characteristics of them. Retrospective data of additional patients are collected to complete the picture of the current situation. These data will be used to define bottlenecks that prevent best clinical practice to be used in daily care at all levels, comparing practice in different countries.Thus, the proposal aims to better understand HF care, which will lead to a better care and finally to improved outcome.

NCT ID: NCT02459626 Completed - Clinical trials for Heart Failure With Normal Ejection Fraction

Left Ventricular Stiffness vs. Fibrosis Quantification by T1 Mapping in Heart Failure With Preserved Ejection Fraction

STIFFMAP
Start date: September 2014
Phase:
Study type: Observational

StiffMAP-HFpEF trial is an investigator initiated, observational, single-center study that will evaluate whether fibrosis quantification by cardiac MRI correlates with left and right ventricular stiffness derived from pressure-volume analysis, aiming to clarify if cardiac MRI is a valid, non-invasive method to assess diastolic function in patients with Heart Failure with preserved ejection fraction.

NCT ID: NCT02459574 Completed - Heart Failure Clinical Trials

Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation

AVATAR-AF
Start date: May 1, 2015
Phase: N/A
Study type: Interventional

A streamlined AF ablation procedure done without PV mapping as a daycase is more effective than anti-arrhythmic drugs at reducing all hospital episodes for recurrent atrial fibrillation.

NCT ID: NCT02457260 Completed - Heart Failure Clinical Trials

Oral Nitrite for Older Heart Failure Patients

ONTx+HF
Start date: January 8, 2016
Phase: Phase 2
Study type: Interventional

Studies have demonstrated nitrite therapy increases adenosine triphosphate (ATP) synthesis in skeletal muscle mitochondria concomitant with reduced whole-body oxygen cost during steady state exercise. Our own work has demonstrated safety and efficacy of an FDA investigational new drug (IND) approved sodium nitrite (10 milligram [mg]) capsule, and its utility to upregulate the sirtuin 3 adenosine monophosphate protein kinase (SIRT3-AMP) pathway of skeletal muscle of younger heart failure (HF) patients. It now seems exceptionally logical and opportune to apply these insights to older HF patients and to delineate mechanisms of disease and aging that respond to nitrite therapy.

NCT ID: NCT02456428 Completed - Clinical trials for Type 2 Diabetes Mellitus

Incretin-based Drugs and the Risk of Heart Failure

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

The purpose of this study is to determine whether incretin-based drugs (used to treat type 2 diabetes) taken either alone or in combination with other anti-diabetic drugs are associated with an increased risk of heart failure (HF) compared to other combinations of oral hypoglycemic agents (OHA). The investigators will carry out separate population based cohort studies using administrative health databases in six jurisdictions in Canada, the US and the UK. Cohorts will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs entered the market, with follow-up until hospitalization for HF. Analyses will be done separately for groups of patients with and without prior HF. The results from the separate sites will be combined to provide an overall assessment of the risk of HF in users of incretin-based drugs and by class of incretin-based drugs.