Sildenafil in HFpEF (Heart Failure With Preserved Ejection Fraction) and PH
Heart FailureDiastolic1 moreAim of the study is to investigate whether Sildenafil treatment results in a reduction of pulmonary artery pressure without decrease of cardiac output (CO) and in improvement of exercise capacity in patients with heart failure with preserved ejection fraction (HFpEF) with pulmonary hypertension ( PH).
Remote Supervision to Decrease Hospitalization Rate
Heart FailurePurpose: Home monitoring (HM) services supplied by different manufacturers (St Jude Medical, Biotronik, Medtronic) enables trained medical staff (doctors, electrophysiology nurses and technicians) to safely follow-up patients with implanted ICD/CRT-D remotely, with omitting unnecessary visits in outpatient clinic, shortening time to medical intervention and therefore help to decrease hospitalization rate among those patients. The RESULT study primary endpoint of the trial will be a composite of all-cause death or hospitalization due to cardiovascular reasons. The primary technical endpoint is to construct and evaluate a unified and integrated platform for data collected from RM devices manufactured by different companies: Carelink™ (Medtronic®, Minneapolis, MN, USA), Merlin™ (Saint Jude Medical®, St. Paul, MN, USA) and Home Monitoring™ (Biotronik®, Berlin, Germany).
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure...
Heart FailureThe purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
Restore Myocardial Function With CorMatrix® ECM® Particulate (P-ECM)
Heart FailureThe purpose of this CorMatrix P-ECM safety and feasibility study is to evaluate the safety and functional effect of the CorMatrix P-ECM.
Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen...
Heart FailureThe proposed study aims to compare the pharmacokinetics and bioavailability of intravenous and subcutaneous Furosemide. Although these regimens are not intended to be bioequivalent, they are both expected to achieve therapeutic plasma levels and induce effective diuresis. The test formulation in this study is a buffered solution, Furosemide Injection Solution at 8 mg/mL at pH 7.4 (range 7.0 to 7.8) and is intended for SC injection according to the instructions in the protocol. A commercial formulation of Furosemide Injection, USP will serve as the reference drug in this study, which will be administered by IV bolus. It contains furosemide 10 mg/mL in solution at alkaline pH of 8.0 to 9.3 and is marketed for IV and IM injection. The objectives of this study are: To characterize the pharmacokinetics of furosemide administered by continuous subcutaneous infusion using a biphasic delivery profile. To estimate the absolute bioavailability of furosemide administered by continuous subcutaneous infusion compared with an equivalent dose of furosemide administered by intravenous bolus administration.
Cardiac Resynchronisation Therapy and AV Nodal Ablation Trial in Atrial Fibrillation Patients (CAAN-AF)...
Heart FailureAtrial FibrillationCardiac resynchronization therapy (CRT) is a treatment for heart failure in patients who also suffer from ventricular dyssynchrony, a form of uncoordinated contraction of the ventricle (lower pumping chamber of the heart). In the past decade, CRT has become an established treatment for heart failure patients who are in normal rhythm, called sinus rhythm. An important subset of heart failure patients are those with atrial fibrillation (AF), who make up around 1 in 4 HF patients, and are over-represented amongst HF patients with more advanced symptoms. In heart failure patients with AF, CRT has proven not to be as effective as in sinus rhythm, due to competition between beats generated by the CRT device and beats conducted from the heart's own electrical conduction system. In the current study, we aim to test the hypothesis that ablating the AV node, which controls electrical conduction from the heart's atria (top chamber) to its ventricles (lower chambers), will improve survival and heart failure symptoms in CRT patients with co-existent AF. The results are important, because they will provide a way of passing on the benefits of CRT, such as improved survival, less heart failure symptoms, and better quality of life, to heart failure patients who also suffer from AF.
Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection...
Heart FailureThis will be a randomized, double-blind, crossover pilot study to measure the safety and feasibility of Interleukin-1 (IL-1) blockade with Anakinra in patients with stable heart failure with preserved ejection fraction.
Safety and Efficacy Study of the BioVentrix PliCath HF System
Heart FailureThe purpose of this prospective, single-armed, multi-center clinical trial is to further establish the safety and feasibility of using the BioVentrix PliCath HF System for the treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from heart failure.
CentriMag RVAS U.S. Post-approval Study Protocol
Right Ventricular FailureThe study objective is to gather post-market clinical data on the use of the CentriMag RVAS when used for temporary mechanical circulatory support of the right ventricle in patients with acute right ventricular failure from any cause
Inspiratory Muscular Training
Heart FailureObjectives: To evaluate regional lung ventilation distribution in patients suffering from chronic heart failure (CHF) after completing inspiratory muscle training (IMT) and correlate it with functional capacity and quality of life among these individuals. Methods and Results: Nineteen CHF patients were randomly assigned to two groups: Control and IMT. Before and after muscle training, subjects were submitted to assessment protocol for respiratory muscles, digital spirometry, optoelectronic plethysmography (OEP), the six-minute walk test (6MWT) and a quality of life questionnaire (MLHFQ). There was no difference in lung function following the 12-week training period in either group. However, the IMT group showed an increase in actual and predicted MIP, higher MLFHQ score and greater distance walked in the 6MWT, as well as a reduction in the Borg scale after the 6 MWT in relation to the control. For the OEP, IMT group members exhibited higher values for total chest wall volume (Vcw), abdominal rib cage volume (Vrc,a) and abdominal volume (Vab) when compared to the control. Conclusions: For patients with CHF, IMT proved efficient in improving muscle strength, functional capacity and quality of life. The present study also analyzed the distribution behavior of lung volumes for the thoracoabdominal system in this population, showing that larger abdominal rib cage and abdomen volumes may result in more effective diaphragmatic contraction.