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Heart Failure clinical trials

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NCT ID: NCT02454751 Completed - Clinical trials for Congestive Heart Failure

The Use of Intranasal Fentanyl for the Treatment of Incident Dyspnea in Congestive Heart Failure: A Prospective Trial

Start date: October 2015
Phase: Phase 2
Study type: Interventional

Study Objective The primary object of this study is to investigate the safety and effectiveness of fentanyl on the management of incident dyspnea. Study Design The study design will be a cross over study with a minimum of a one hour wash out period.

NCT ID: NCT02452515 Completed - Heart Failure Clinical Trials

A Single-blind Pilot Study to Investigate Safety and Tolerability of the Chymase Inhibitor BAY1142524 in Clinically Stable Patients With Left-ventricular Dysfunction

CHIARA MIA 1
Start date: July 2015
Phase: Phase 2
Study type: Interventional

The purpose of the trial is the analysis of safety and tolerability of the chymase inhibitor BAY1142524 in comparison to placebo using a 2 weeks treatment period in clinically stable patients with left-ventricular dysfunction after myocardial infarction. BAY1142524 or placebo will be given on top of evidence-based standard of care for left-ventricular dysfunction after myocardial infarction. Primary objectives are the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. BAY1142524 will be administered in a parallel group design using four doses (5, 10, 25 mg twice daily, and 50 mg once daily). Each dose group consists of 9 patients treated with verum and 3 patients treated with placebo.

NCT ID: NCT02448147 Completed - Heart Failure Clinical Trials

Interval Versus Continuous Training in Heart Failure

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

BACKGROUND: The physiopathology of the heart failure involves compensatory mechanisms as exacerbated neurohormonal activity, endothelial dysfunction and consequently the muscle disability and exercise intolerance. The interval exercise training has been proposed as one efficient method to heart failure patients. It seems that the main mechanism involved in the benefit of the interval exercise training is "shear stress". AIM: To study the interval exercise training versus the continuous exercise training in the sympathetic activity and in the peripheral muscle perfusion in heart failure patients. Moreover, we will evaluate the muscle apoptosis, microRNA in plasma and muscle biopsy, biomarkers levels of inflammation, quality of life and exercise capacity. METODOLOGY: Will be selected 40 patients (male and female) with age between 30 and 60 years, left ventricular ejection fraction less than 40% and functional class I, II and III. These patients will be randomized into three groups: Interval (AIT), continuous (MCT) and control (CG). All patients will be evaluated with microneurography, peripheral muscle perfusion, muscle biopsy, blood samples, accelerometer, cardiopulmonary exercise test and quality of life before and after end of the period of 03 (three) months.

NCT ID: NCT02446990 Completed - Clinical trials for Coronary Artery Disease

Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure

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

The purpose of this study is to evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.

NCT ID: NCT02446327 Completed - Clinical trials for Diastolic Heart Failure

The Metabolic Road to Diastolic Heart Failure: Diastolic Heart Failure Study

MEDIA-DHF
Start date: January 2012
Phase: N/A
Study type: Interventional

The main objective is to replicate the validation of omics biomarkers of left ventricular diastolic dysfunction in patients with metabolic syndrome. The aim was to recruit overall 750 patients in Europe (100 for France). Currently, 625 patients were enrolled in Europe and 47 in France.

NCT ID: NCT02444676 Completed - HEART FAILURE Clinical Trials

Heart Failure STratification and OutcomeS

HEFESTOS
Start date: March 2015
Phase:
Study type: Observational

Background: Heart failure (HF) is in many cases the final way for coronary heart diseases. In older than 65 years is the most important cause of hospitalization. Many studies have analyzed the causes of decompensation and the possible causes of hospital re-admission but most evidences come from the hospital setting. Nevertheless, It is known that many of these patients are usually attended in primary care setting, being treated by their General Practitioner and are not referred to the hospital. The determinants which condition whether stable HF patients will be hospitalized as a consequence of a decompensation remain still unclear. Objective: To develop and validate a predictive model based on clinical variables easy to measure at primary care to predict short-term hospitalization or mortality in a cohort of patients attended in primary care setting as a consequence of a HF decompensation. Methods: A cohort of patients with established HF attended in primary care setting (regular care or out of hours) as a consequence of an episode of HF decompensation will be follow up. To develop the predictive model we will select variables which previously have been found involved in the risk of hospitalization or mortality as a consequence of HF as well as other ones which could be relevant and have not been studied yet. Variables selected should be easily determined in primary care setting.. The predictive model obtained in the derivation cohort from Spain will be validated in an external (several European countries) validation cohort. Relevance: Our study will help GP to identify HF patients at higher risk of hospitalization or death and manage them according to an accurate prognostic rule (escala pronostica) made in primary care setting.[DISCUTIR]

NCT ID: NCT02441218 Completed - Clinical trials for Chronic Heart Failure

Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study

SHIFT
Start date: September 2006
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left ventricular ejection fraction and currently receiving recommended therapy for this disease.

NCT ID: NCT02440620 Completed - Breast Cancer Clinical Trials

Cardiac Toxicity in Medical Treatment of Breast Cancer

CaTOB
Start date: October 2014
Phase:
Study type: Observational

This study will describe the epidemiology including prognosis of heart failure related to treatment with anthracycline and trastuzumab for breast cancer. In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer patients scheduled for trastuzumab treatment at Odense University Hospital, will be offered advanced echocardiographic examination, test of bio-markers and genetic markers for the purpose of investigating if early identification of patients in particular risk of developing heart failure is feasible.

NCT ID: NCT02437058 Completed - Heart Failure Clinical Trials

Validity of Scales to Assess Severity in Acute Heart Failure

AHFRS
Start date: January 2011
Phase:
Study type: Observational [Patient Registry]

The scales measuring the severity of acute decompensate heart failure (ADHF) in emergency departments have not achieved an adequate discriminative ability for decision making. Objectives: 1) Identify baseline variables, and evolutionary variables that may provide a good predictive ability of the model.2) Create and validate clinical predictive rules of mortality during admission/a week after ED visit in those discharged from ED, 30 and 60 days after ED visit as well as identify predicitive factors of short-term readmission (90 days)Design: Prospective cohort study. The sociodemographics and clinical variables will be collected from emergency medical records to identify predictors. Outcome variables and evolution of variables will be collected from hospital medical records / ambulatory during admission and up to 90 days after the episode of ADHF. Baseline predictors and evolutionary variables will be identified through logistic regression models using 60% of the final sample. The models that best fit will be applied in 40% of the sample to assess the predictive validity of this scale.

NCT ID: NCT02436161 Completed - Heart Failure Clinical Trials

Effectiveness of a Multidisciplinary Care Management Program for High-risk Patients With Heart Failure (PROMIC)

PROMIC
Start date: May 2011
Phase: Phase 2
Study type: Interventional

OBJECTIVE: To evaluate the effectiveness of a multidisciplinary care management collaborative program for high-risk patients with heart failure (HF) who are admitted at hospital, based on the 6 components of the Chronic Care Model "PROMIC", in terms of reduction of a Combined event rate (readmissions / cardiac events / death / emergency department visits) and other variables, the feasibility of the program, the improvement on quality of life related to health and functional capacity of the PROMIC patients compared with control patients in usual care. DESIGN: A quasi-experimental, prospective one year follow-up study. SETTING AND SUBJECTS: Primary Health care Centres of Interior County in Bizkaia and of Araba County in Araba, Galdakao Hospital, Santa Marina Hospital and University hospital os Araba in the Basque Country. Will be captured as a minimum intervention group of 125 patients admitted for HF in New York Heart Association (NYHA) functional status II-III-IV from previous mentioned hospitals. Another 125 patients from different primary health care centers, will be the control group. INTERVENTION: The intervention to be applied will be PROMIC, control patients will receive usual care MEASUREMENTS: The mean outcome measure will be the time free of events from the time of inclusion to the first event (readmission / cardiac events / death / emergency visits). Secondary endpoints will be the quality of life related to health (MLFHQ and SF-12), functional capacity (6-Minute Walk Test), structural changes in cardiac structure (natriuretic peptide levels), adherence to drug treatment (Morinsky-Green), the cost of the program, the usefulness and acceptability of PROMIC by professionals and patients. Predictor variables also will be collected such as sex, age, education level, co-morbidity, social risk level, dependency etc. STATISTICAL ANALYSIS: Analysis was performed by intention to treat. Survival curves will done. A model of Cox proportional hazards will be built.