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Heart Failure clinical trials

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NCT ID: NCT02275013 Completed - Clinical trials for Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery

Levosimendan Administration and Outcome in Cardiac Surgery

Start date: January 2006
Phase: N/A
Study type: Observational

To assess the effects on outcome of levosimendan with respect to timing of its administration on the postoperative course of high-risk cardiac surgery patients in a retrospective observational study.

NCT ID: NCT02271230 Completed - Heart Failure Clinical Trials

Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure

Start date: August 2014
Phase: Phase 3
Study type: Interventional

This study will examine whether an intervention with vitamin D or fish oil supplements can reduce the risk of heart failure among adult men and women during a follow up period of up to five years (starting from the time of randomization into the parent VITAL trial). The investigators hypotheses are that both vitamin D and fish oil supplements will each reduce the risk of heart failure.

NCT ID: NCT02269618 Completed - Heart Failure Clinical Trials

Telehealth Program in Chronic Patients

Start date: June 2013
Phase: N/A
Study type: Interventional

The aim of this randomized control study is to determine the feasibility and efficacy of an innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the study and followed for 4 months and for additional 2 months of follow-up. The primary outcome is to improve tolerance capacity

NCT ID: NCT02268942 Completed - Clinical trials for Left Sided Heart Failure

HW006 LATERAL Thoracotomy

HVAD
Start date: November 2014
Phase: N/A
Study type: Interventional

This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs®) protocol and database. All participating centers are current INTERMACS® sites in good standing and follow the INTERMACS® protocol and procedures.

NCT ID: NCT02268500 Completed - Clinical trials for Chronic Heart Failure

VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)

VACC-HeFT
Start date: September 2014
Phase: Phase 4
Study type: Interventional

A multi-center, prospective, randomized, open-label blinded-endpoint trial in patients with heart failure will be conducted; 20 will be assigned to the standard dose vaccine dose and 20 patients to high dose influenza vaccine. Post-vaccine antibody measurements will be assessed, as well as tolerability differences between groups.

NCT ID: NCT02263482 Completed - Clinical trials for Chronic Heart Failure

Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure

Start date: October 2012
Phase: N/A
Study type: Interventional

Heart failure is a clinical syndrome that is the common end of several cardiac diseases with symptoms such as muscle fatigue, dyspnea and reduction of quality of life. To improve respiratory and general functional capacity of these patients, there are strategies that can be used such as inspiratory muscle training and peripheral muscle training (dynamic resistance training).

NCT ID: NCT02262078 Completed - Heart Failure Clinical Trials

Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction

Start date: October 2014
Phase: Phase 2
Study type: Interventional

Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. This study will assess the effects of nebulized inhaled nitrite administration on resting and exercise hemodynamics in patients with HFpEF referred to the catheterization lab.

NCT ID: NCT02261948 Completed - Heart Failure Clinical Trials

Levosimendan Efficacy Assessment by Cardiopulmonary Exercise Test (CPET)

Start date: September 2012
Phase: Phase 4
Study type: Interventional

The present study was conceived to evaluate the effects of levosimendan on cardiopulmonary exercise test (CPET) and DLCO ( Diffusion capacity of Lung for carbon monoxide) in patients with severe heart failure in stable clinical conditions (NYHA - New York Heart Association - class III, with a peak VO2 (Oxygen consumption ) < 12 ml/min/kg) on top of optimized standard therapy.

NCT ID: NCT02258516 Completed - Clinical trials for Self-management in Heart Failure

A Randomized Study of the Efficacy of a New Intervention for Medication Adherence in Chronic Illness: Medications, Meaning and Me (The 3-M Study)

Start date: September 2009
Phase: N/A
Study type: Interventional

Purpose of the study - The purpose of this study is to develop and evaluate the efficacy of a new, theoretically based intervention to improve medication adherence in persons with HF. The hypotheses include: Hypothesis I. Poorly adherent patients with symptomatic HF who receive the intervention (n=40) will be more adherent to medicines during the12-month intervention than a control group (n=40) of poorly adherent patients with symptomatic HF. Hypothesis II. Poorly adherent patients with symptomatic HF who receive the intervention (n=40) will have fewer hospital readmissions (HR) and emergency department (ED) visits during the 12-month intervention than a control group of poorly adherent patients with symptomatic HF. Study Activities and population - A prospective, randomized controlled design will be used to pilot test the efficacy of a new intervention to promote adherence to the medication regimen in chronic heart failure in the clinical setting. The initial development and feasibility testing of the intervention is complete (Preliminary Work, Section 4.5). Patients with HF symptom exacerbation (n = 80) who exhibit high likelihood of poor adherence, as determined by a validated screening measure, the Medication Adherence Scale (MAS)89 at baseline assessment, will be recruited and randomized to receive the intervention or usual care with attention control. Medication adherence, symptom frequency and intensity, hospital readmissions (HR) and emergency department (ED) visits will be assessed in both groups at 3, 6 and 12-month clinic visits. The intervals between visits are considered sufficient to minimize sensitization bias to psychometric measures. Longitudinal measurement is required to evaluate the magnitude of change in adherence and symptom-related events occurring over time. Efficacy will be measured as improved adherence (primary outcome) and decreased HR and ED visits (secondary outcomes) in the intervention group as compared to the attention control group at 12 months. The study will close when all patients have had a 12-month post-enrollment clinic visit. Data Analysis & Safety/Risk Considerations - The investigators will use generalized linear models to test the primary and secondary hypotheses (McCullagh and Nelder, 1989). Logistic generalizations of the traditional, multivariate GLM are appropriate when the dependent variable is binary and the probability of an event is modeled, as is the case with adherence in this study. When the dependent variable is a count, a commonly used generalized model uses the natural logarithm of the count, as with re-hospitalizations and ED visits in this study. In compliance with NIH guidelines for data safety and monitoring activities, a number of quality control steps will be used to ensure the on-going safety of participants and the scientific integrity of this feasibility intervention study. The proposed study poses only very minimal risks to participants. All participants will receive usual care. Participation in the study will not replace patients' regular health care attention. Data safety will be monitored by the PI, the Data Safety Officer (Dr. Karl Swedberg), and the study co-investigators. Any adverse events will be reported immediately to the Duke IRB and the NIH. Data Safety. First, a project database will be constructed, using participant ID numbers and including all demographic, pre- and post-intervention history and all assessment materials. A separate file, cross-referencing participant identification with project ID numbers, will be maintained with access limited to the PI or a designated member of the investigative team.

NCT ID: NCT02258061 Completed - Heart Failure Clinical Trials

Optimal Cardiac Resynchronization Therapy Pacing Rate

Start date: August 2011
Phase: Phase 0
Study type: Interventional

The optimal pacing rate during cardiac resynchronization therapy (CRT) is not known. Investigators investigate the impact of changing basal pacing frequencies on autonomic nerve function, cardiopulmonary exercise capacity and self-perceived quality of life (QoL).