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Heart Failure clinical trials

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NCT ID: NCT02170363 Completed - Clinical trials for Advanced Refractory Left Ventricular Heart Failure

HeartMate 3™ CE Mark Clinical Investigation Plan

HM3 CE Mark
Start date: June 2014
Phase: N/A
Study type: Interventional

The purpose of this clinical investigation is to evaluate the performance and safety of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the HM3 LVAS in Europe, a multi-center clinical study will be conducted in multiple countries. The clinical study will be conducted in compliance with the Declaration of Helsinki, ICH/GCP and EN ISO 14155:2011 Requirements for Clinical Investigations and in accordance with country-specific requirements, under one clinical study protocol. This study will evaluate the performance of the HM3 LVAS, side effects and undesirable conditions within acceptable risks and weigh them against the intended performance of HM3 LVAS in accordance with Essential Requirements 2, 5 and 16 of the Active Implantable Medical Device Directive 90/385/EEC (AIMDD).

NCT ID: NCT02167789 Completed - Heart Failure Clinical Trials

Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device

CLEPSYDRA
Start date: September 2009
Phase: Phase 3
Study type: Interventional

This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).

NCT ID: NCT02166762 Completed - Heart Failure Clinical Trials

Correlating QLV Interval to Left Ventricular (LV) Lead Position in Patients Receiving Cardiac Resynchronization Therapy.

QLV
Start date: May 2013
Phase: N/A
Study type: Interventional

This is a prospective clinical trial to determine the optimal QLV interval during implantation to achieve the best possible response from cardiac resynchronization therapy for heart failure patients.

NCT ID: NCT02161445 Completed - Dyspnea Clinical Trials

Systolic Time Intervals in the Diagnosis of Heart Failure in Emergency Departement

STA/AHF
Start date: October 2, 2012
Phase:
Study type: Observational

the gold standard for the diagnostic of acute heart failure is based on clinical, biological (BNP levels) and echocardiographic findings, but still in some cases, the diagnosis is difficult and requires further investigations. BNP dosages and echocardiography are not always available in many medical centers, especially in emergency departements, and are expensive. we investigated the use of alternative methods, such as the systolic time intervals (STI), in the diagnosis of acute heart failure (AHF) in emergency departement patients consulting for dyspnea.

NCT ID: NCT02157506 Completed - Heart Failure Clinical Trials

A Dose Ranging Phase IIa Study of 6 Hour Intravenous Dosages of CXL-1427 in Patients Hospitalized With Heart Failure

Start date: June 30, 2014
Phase: Phase 2
Study type: Interventional

A randomized, double-blinded, placebo-controlled study of continuous 6-hour IV infusions of CXL-1427 in hospitalized patients with systolic heart failure.

NCT ID: NCT02156583 Completed - Clinical trials for Systolic Heart Failure

Frailty: Prevalence and Response to Left Ventricular Assist Device Therapy in Older Heart Failure Patients

Start date: May 2014
Phase:
Study type: Observational

This is an observational study evaluating changes in frailty and associated impairments in older heart failure patients receiving left ventricular assist device therapy.

NCT ID: NCT02153892 Completed - Clinical trials for Severe Functional Mitral Regurgitation and Heart Failure

Feasibility of the AccuCinch® System for Left Ventricular Reshaping of the Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve Left Ventricular Function

LVRECOVER
Start date: August 2014
Phase: N/A
Study type: Interventional

To assess the safety and performance of the GDS Accucinch System when used percutaneously to reduce functional mitral regurgitation.

NCT ID: NCT02151994 Completed - Clinical trials for Hypertension and Chronic Heart Failure

Safety, Tolerability, Pharmacokinetic, Including Food Interaction, and Pharmacodynamic Profile of BIA 5-1058.

Start date: March 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to to assess the safety and tolerability of BIA 5 1058 after single and multiple oral doses

NCT ID: NCT02151266 Completed - Heart Failure Clinical Trials

Exercise and Cognitive Retraining to Improve Cognition in Heart Failure.

EXCITE
Start date: July 2013
Phase: N/A
Study type: Interventional

Cognitive impairment (CI) is a prevalent problem in persons with HF heart failure (HF) and is associated with adverse clinical outcomes, higher mortality and poorer quality of life. Studies designed to attenuate or alleviate CI in persons with HF are limited, and evidenced based guidelines for screening and provision of care are practically nonexistent. Improvement in cognition has been reported following some therapies in HF and is thought to be the consequence of enhanced cerebral perfusion and oxygenation, suggesting that CI may be amenable to intervention in this population. Exercise is documented to increase cerebral perfusion and oxygenation by promoting neuroplasticity and neurogenesis, and, in turn, cognitive functioning. Brain derived neurotrophic factor (BDNF) is a key mechanism underlying the effect of exercise, but most studies of BDNF have not included individuals with CI or chronic illness populations, and its relationship to cognitive outcomes in HF is unknown. Cognitive retraining techniques, originally developed to treat traumatic brain injury, have also shown efficacy in broader neurologically-affected conditions and may provide added benefit to that of exercise. Animal studies suggest exercise and plasticity-based cognitive training could act synergistically through different neural mechanisms to have a more pronounced and positive impact on cognitive outcomes than either approach alone; but this has not been previously tested as an intervention to improve CI. The proposed feasibility study is designed to test the acceptability and limited efficacy of a combined exercise (Ex) and cognitive training (CT) program to improve CI in stable NYHA class II and III HF patients compared to either exercise alone or a no-intervention, attention-control group. Findings will be used to support the development of a future, large scale study to test the efficacy of this intervention to improve cognitive functioning, quality of life, and physiological markers of improved brain function in HF. In addition, we have an optional sub-study that participants may participate in order to further our understanding of biomarkers of inflammation and gen e expression before and after exercise.

NCT ID: NCT02150798 Completed - Heart Failure Clinical Trials

The Effects of a High Fat and Low Carbohydrate Diet on Clinical Status in Patients With Heart Failure

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

The aim of the present study was to evaluate the effects of a high fat, low carbohydrate (CHO) diet on clinical status during 60 days of follow-up in patients with stable heart failure (HF). In a randomized controlled clinical trial 44 ambulatory patients with HF were included, assigned to an intervention (40% CHO, 40% fat and 20% protein; n=22) or control groups (50% CHO, 30% fat, 20% protein; n=20). Both groups received recommended pharmacological management. At baseline and at 2 months of follow-up, the variables evaluated were: body composition, handgrip strength, oxygen saturation, dietary intake, clinical data, lipid profile, plasma glucose and exercise tolerance