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Heart Failure clinical trials

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NCT ID: NCT03082508 Not yet recruiting - Heart Failure Clinical Trials

A Pivotal Trial to Establish the Efficacy and Safety of Algisyl in Patients With Moderate to Severe Heart Failure

AUGMENT-HFII
Start date: August 2017
Phase: N/A
Study type: Interventional

AUGMENT-HF II is a study to evaluate the efficacy and safety of the Algisyl device. The purpose of this study is to investigate Algisyl employed as a method of left ventricular augmentation and restoration in patients with dilated cardiomyopathy. Algisyl will be injected into the myocardium under direct visualization during the surgical procedure. Structural abnormalities in the heart are known to play a central role in HF, and clinical evidence supports a strong causal relationship between cardiac chamber dilation and heart failure. Because dilation, and not contractile dysfunction, appears to be responsible for the severity of the disease, the mitigation or prevention of the deleterious structural abnormalities of the left ventricle appears to be an important therapeutic target for patients with this life threatening illness. Hence, a therapy that specifically reduces LV wall stress, targets LV dilatation and LV remodeling may offer an important new alternative in the treatment of heart failure. Algisyl is being investigated based on evidence that suggests an ability of the implants to reduce wall stress, reshape the LV chamber and reduce the LV chamber size as well as prevent the progressive ventricular dilation and remodeling associated with HF. The physiologic response to progressive exercise using direct measures of ventilation and gas exchange via the cardiopulmonary exercise test is an important diagnostic tool in the management of the patient with HF, quantifying responses to therapy, and as a reliable prognostic utility for predicting outcomes in patients with HF. Numerous studies have established the strong association of peak VO2 with mortality and morbidity risk in HF. Peak VO2 conceptually is considered an overall global marker of cardiopulmonary health and is a reflection of the degree of impairment in ventricular function ( the heart's pumping capacity), oxygen delivery and oxygen utilization. Hence, employing the change in peak VO2 as a primary endpoint in this clinical study provides a strong objective measure that can be interpreted in independent blinded fashion, to evaluate the result of the therapeutic intervention and provide an equally strong assessment of the prognostic implications for patients in the study. This clinical evaluation is intended to provide confirmatory evidence of the effectiveness and safety of the device Algisyl in patients with advanced heart failure.

NCT ID: NCT03060148 Not yet recruiting - Heart Failure Clinical Trials

Spinal Cord Stimulation in Heart Failure

Start date: June 2017
Phase: N/A
Study type: Interventional

Previous studies have shown that spinal cord stimulation (SCS) may improve cardiac output and decrease the risk of ischemic ventricular arrhythmia in animal model and its safety profile in human trial. The purposes of this study are to evaluate the feasibility, treatment efficacy and safety of SCS in patients with severe symptomatic heart failure (HF).

NCT ID: NCT02934971 Not yet recruiting - Clinical trials for Toxicity Due to Chemotherapy

Optimized Multi-modality Machine Learning Approach During Cardio-toxic Chemotherapy to Predict Arising Heart Failure

MERMAID
Start date: January 2017
Phase: N/A
Study type: Observational

The present project will develop an automated machine learning approach using multi-modality data (imaging, laboratory, electrocardiography and questionnaire) to increase the understanding and prediction of arising heart failure in patients scheduled for cardio-toxic chemotherapy. This algorithmus will be developed by the technical cooperation partner at Technion, the institut for biomedical engineering in Haifa, Israel.

NCT ID: NCT02888561 Not yet recruiting - Heart Failure Clinical Trials

Haemodynamic Effects of Dobutamine and Nitrite in LV Dysfunction

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

Patients with poor heart function can, in certain situations, have a further weakening of the heart muscle such that it becomes difficult to provide enough blood to the brain and other organs. In these cases, heart function can be supported by the use of medicines or heart pumps. One of the most widely used medicines is Dobutamine, given as an infusion (a drip). Although Dobutamine has been in use for decades and does improve blood flow to the organs, previous studies have not shown any impact on recovery of heart muscle function and survival. Key to unravelling this discrepancy is to understand the precise effects of Dobutamine on the oxygen supply to, and oxygen usage by, the heart muscle. We also aim to find out whether simultaneous infusion of another drug called Nitrite (naturally occurring substance that is found in beetroot for example, much like GTN) can enhance the beneficial effects of Dobutamine on the oxygen supply-demand balance of the heart. In recent years, major advances in technology mean that it is now possible to obtain this information in patients undergoing coronary angiography procedures by making detailed measurements of heart muscle function and blood flow in the heart arteries using a conductance catheter (measures volume and pressure within the main pumping chamber of the heart) and the Combowire (dual pressure and flow sensor tip angioplasty guidewire). The aim of this study is to understand the effect of a brief infusion of Dobutamine and nitrite on heart muscle function, oxygen supply and oxygen usage through this use of this technology, directly following the patients routine coronary angiogram. Patients will have these measurements taken using the technology described above during the infusion of both dobutamine and nitrite, inserted through blood vessels that reach the heart.

NCT ID: NCT02824692 Not yet recruiting - Clinical trials for Congestive Heart Failure

Preoperative Significant Clinical Findings Using Focused Ultrasound Examination

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

The purpose of this study is to determine whether a focused ultrasound examination for the heart, lungs and abdomen, preformed by a trained anesthesiologist, can reveal significant clinical findings in elderly patients before emergent surgery.

NCT ID: NCT02784912 Not yet recruiting - Heart Failure Clinical Trials

Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation

STORM
Start date: September 2017
Phase: N/A
Study type: Observational [Patient Registry]

Prevalence of HF reaches 1-2% of developed populations, and consequently a significant problem becomes more frequent occurrence of ventricular arrhythmias (VA) - sustained ventricular tachycardia (sVT) and electrical storm (ES) requiring radiofrequency ablation. The aim of the study is to create a model of risk stratification to identify patients with increased risk of occurrence of composite (cardiovascular death or rehospitalization, arrhythmia recurrence) and secondary (inadequate device therapy, all-cause death or rehospitalization, intensification of atrial arrhythmia) endpoints after ablation of ES or sustained VT. Model will be based on additional measurements of N-terminal pro brain natriuretic peptide (NT-proBNP), Galectin-3, suppressor of tumorigenicity 2 (ST2), high sensitive troponin T (hs-TnT), high sensitive C-reactive protein (hs-CRP), iron deficiency to clinical-, electrocardiographic- and echocardiographic assessment.

NCT ID: NCT02780947 Not yet recruiting - Heart Failure Clinical Trials

Prophylactic Substrate Ablation in Post-myocardial Patients Undergoing Defibrillator Implantation.

Start date: June 2016
Phase: N/A
Study type: Interventional

Prophylactic substrate ablation in post-MI patients undergoing defibrillator implantation reduces appropriate defibrillator therapies.

NCT ID: NCT02779634 Not yet recruiting - Heart Failure Clinical Trials

Ubiquinol Treatment in Patients With Heart Failure and Preserved Ejection Fraction

Start date: July 2016
Phase: Phase 2
Study type: Interventional

There are no studies specifically examining the effects of coenzyme Q (CoQ) treatment on echocardiographic indices of diastolic function in elderly patients with heart failure with preserved ejection fraction (HFPEF). In previous studies the only echocardiographic parameters studied were ejection fraction (EF) and chamber size. The objective of the proposed current study is to examine the effect of 16 weeks of ubiquinol therapy on diastolic function assessed by echocardiography in patients over the age of 50 with a clinical diagnosis of HFPEF. Ubiquinol (Kaneka Pharma), the reduced form of CoQ will be utilized for this study as it has been shown to have superior bioavailability when compared to oxidized CoQ.

NCT ID: NCT02775539 Not yet recruiting - Heart Failure Clinical Trials

Beta3 Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure

SPHERE-HF
Start date: June 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of mirabegron (a B3 adrenergic receptor agonist) in patients with pulmonary hypertension secondary to heart failure by conducting a randomized multicenter phase II placebo-controlled clinical trial.

NCT ID: NCT02763982 Not yet recruiting - Heart Failure Clinical Trials

Cardiac Function and Inspiratory Muscles Performance

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

The purpose of this study is to determine whether ejection fraction and peak oxygen uptake have correlation on inspiratory muscle strength, chest wall volumes and quality of life in individuals with heart failure.