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Heart Failure clinical trials

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NCT ID: NCT02696005 Not yet recruiting - Heart Failure Clinical Trials

Hormone KLOTHO Level in Heart Failure Patients That Participate in Rehabilitation Programme

Start date: March 2016
Phase: N/A
Study type: Observational

30 patients suffering from Heart Failure with Ejection Fraction less than 40% start Cardiac Rehabilitation Programme, serum KLOTHO Hormone level and other labs and Echo measurements will be taken on the first visit. After completion of 3-month Rehabilitation Programme the second set of labs and Echo measurements will be taken. Than participants will be divided for 2 groups: the patients who wish to continue Rehabilitation programme for additional 3-month period and the second group that prefer to stop Rehabilitation programme after completion of the first 3 month period. For both groups additional set of labs will be taken this time and at the end of the study. The Aim of the study: to investigate association between serum KLOTHO level, physical activity and possible correlation with laboratory and echocardiographic parameters in cohort of Heart Failure patients.

NCT ID: NCT02655185 Not yet recruiting - Heart Failure Clinical Trials

Novel Risk Factors of Atrial Fibrillation in Patients With Chronic Heart Failure

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

The purpose of this study is to determine whether lipid levels are related with incidence of atrial fibrillation in Patients with chronic heart failure.

NCT ID: NCT02654678 Not yet recruiting - Heart Failure Clinical Trials

Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril

LENA-WP10
Start date: March 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Paediatric long-term safety follow-up clinical trial in maximum 100 children with heart failure due to dilated cardiomyopathy or congenital heart disease, from 1 day to less than 12 years of age at recruitment into the preceding short-term pharmacokinetic (PK)/pharmacodynamic (PD) trials. Pharmacodynamic measurements and renal monitoring in all children after 1 , 4, 7 and 10 months of follow-up; in addition PK assessments as well as acceptability and palatability assessments in children still under enalapril Orodispersible Minitablet (ODMT) treatment.

NCT ID: NCT02652741 Not yet recruiting - Heart Failure Clinical Trials

Orodispersible Minitablets of Enalapril in Young Children With Heart Failure Due to Congenital Heart Disease

LENA-WP09
Start date: January 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Paediatric clinical trial in 50 children, from newborn to less than 6 years of age, suffering from heart failure due to congenital heart disease, to obtain paediatric pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to describe the dose exposure in this patient population.

NCT ID: NCT02652728 Not yet recruiting - Heart Failure Clinical Trials

Orodispersible Minitablets of Enalapril in Children With Heart Failure Due to Dilated Cardiomyopathy

LENA-WP08
Start date: January 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Paediatric clinical trial in 50 children, from 1 month to less than 12 years of age, suffering from heart failure due to dilated cardiomyopathy, to obtain paediatric pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to describe the dose exposure in this patient population.

NCT ID: NCT02642081 Not yet recruiting - Heart Failure Clinical Trials

Non-steroidal Anti-inflammatory Drugs (NSAIDs) and Risk of Acute Kidney Injury in Patients With Heart Failure

Start date: January 2016
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate whether non-steroidal anti-inflammatory drugs (NSAIDs) were associated with acute kidney injury (AKI) in patients with heart failure. In addition, the investigators would like to assess the risk of admission for acute decompensated heart failure following exposure to NSAIDs within 30 days.

NCT ID: NCT02555904 Not yet recruiting - Heart Failure Clinical Trials

VoIce Changes and Heart Failure

Start date: October 2015
Phase: N/A
Study type: Observational

This is an observational, single center study to evaluate if acoustic and accelerometer-based measures of voice and speech have sufficient precision to detect a change in lung fluid status for patients with confirmed acute heart failure syndrome with pulmonary congestion. The study shall be conducted in concordance with the United States FDA regulations for a non-significant risk study. Patients admitted for acute heart failure syndrome with pulmonary congestion with an expected stay greater than 3 to 4 days, who are willing and able to sign an informed consent, and who meet all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study. Results of this study will evaluate the sensitivity of voice and speech measures in detecting changes in lung fluid status in a symptomatic population. Up to 12 subjects will be enrolled to comparatively evaluate the voice outcome measures in this pilot study.

NCT ID: NCT02509754 Not yet recruiting - Clinical trials for Persistent Atrial Fibrillation

Atrial Fibrillation Ablation Compared to Rate Control Strategy in Patients With Impaired Left Ventricular Function

AFARC-LVF
Start date: January 2016
Phase: Phase 4
Study type: Interventional

Atrial fibrillation (AF) and congestive heart failure (CHF) are two epidemics that share several physiopathological links. CHF patients present a significantly increased risk of developing AF and the related detrimental hemodynamic effects are even more relevant than in patients without CHF. Within CHF patients rate control is the most widely used strategy to manage AF, having proved non-inferior to rhythm control strategies. However, by this strategy, the hemodynamic effects of AF persist, not contrasting the natural evolution towards progressive left ventricular (LV) function, cardiac output , and symptoms worsening. Rhythm control strategy, instead, has shown, in the general population, advantages over rate control concerning survival, quality of life and thromboembolic events. The main limitation is that antiarrhythmic therapy used to achieve this goal has several side effects, and that transcatheter AF ablation has been assessed only in modest sample size studies. Available literature focusing on a direct comparison between two specific management strategies in patients with CHF and AF is limited to a small randomized study comparing pulmonary veins isolation to AV node ablation and biventricular PM implantation (PABA-CHF study). Additional indirect evidences may derive from meta-analyses of observational studies. The investigators therefore designed this multicenter, randomized controlled trial aiming to assess if, in recently diagnosed (less than 6 months) and optimally treated CHF patients with impaired LV function, AF catheter ablation is effective in improving LV function and clinical functional class, potentially driving to a reduction of device implantations (ICD/CRTs).

NCT ID: NCT02506166 Not yet recruiting - Heart Failure Clinical Trials

European Sleep Apnea and Sudden CArdiac Death ProjEct

ESCAPE-SCD
Start date: January 2016
Phase: N/A
Study type: Interventional

The objective of ESCAPE-SCD Study is assessment of the effect of sleep apnea on sudden cardiac death risk and cardiovascular outcomes in patients with ischemic cardiomyopathy. The ESCAPE - SCD Study will address following specific study questions: - Is obstructive sleep apnea (OSA) and/or central sleep apnea (CSA) an independent risk factor of sudden cardiac death (SCD) in patients with ischemic cardiomyopathy (ICM) indicated for ICD/CRT-D implant based on current European Society of Cardiology (ESC) Guidelines for primary prevention of sudden cardiac death? - Can treatment of predominant (>50%) obstructive sleep apnea by appropriate Positive Airway Pressure (PAP) therapy decrease risk of sudden cardiac arrhythmic death in ICM patients? - Can treatment of predominant (>50%) obstructive sleep apnea by appropriate PAP therapy improve cardiovascular outcomes in ICM patients indicated for ICD/CRT-D implant? - Does obstructive sleep apnea represent a novel factor that may improve risk stratification of sudden cardiac death and advance identification of those patients that will benefit from ICD/CRT-D therapy?

NCT ID: NCT02471729 Not yet recruiting - Clinical trials for Chronic Heart Failure

Effect at 6 Months of Renal Denervation in Chronic Heart Failure d'Insuffisance Cardiaque

DENRENIC
Start date: January 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Management of chronic heart failure (CHF) is a major public health problem. It is associated with high mortality, frequent hospitalization and represents a large cost to the health care system. Both pharmacological and non-pharmacological intervention haven't shown to be effective in reducing morbidity and mortality of these patients when able to modulate the activity of neuro-hormonal systems among them the sympathetic nervous system. Recent data have emphasized the potential role of sympathetic renal denervation in patient with hypertension. CHF per se but even more CHF associated with comorbity lead to significant increase level of sympathetic tone. This is largely induced by autonomic dysfunction such as chemo or baroflex abnormalities. These patients usually suffer from conditions which do not allow upgrading and adapting drugs to their sympathetic condition. Hence CHF patient with chronic kidney disease, anemia or both have markedly high sympathetic activity and cannot be exposed to higher level of RAS Blockers or beta blocker due to their renal dysfunction, they thus remain with an elevated sympathetic activity worsening symptoms and prognosis. Chronic heart failure affects around 100 million people worldwild imposing a significant burden on health care system throughout the world. Even though symptoms are improved by heart failure therapy, they remain significantly disabling for many patients. Chronic over activation of the sympathetic nervous system is a major component of heart failure and involves efferent and afferent pathways between brain and many organs. A new therapy directly targeting nerve traffic-renal artery denervation- has been shown to be effective in drug resistant hypertension, with an average drop in blood pressure of 33/12 mm hg. The cardiologists team of the private hospital Arnault Tzanck is willing therefore to conduct a study in 12 patients with chronic systolic heart failure undergoing bilateral renal denervation with an intensive protocol of observation and assessment compring a 3 day hospital stay post procedure 3 and 6 months of regular outpatient follow-up.