Effectiveness of a Diuretic Algorithm in Clinical Stability in Heart Failure Patients
Heart FailureOne of the challenges in treating patients with heart failure (HF) is achieving clinical stability and reducing the hospital readmission rate. A diuretic dose adjustment algorithm developed in the United States (Diuretic Treatment Algorithm, DTA) and later validated for use in Brazil (as the Algoritmo de Ajuste de Diurético, AAD) has proved feasible and readily applicable, but its effect on clinical outcomes has yet to be assessed. This report aims to describe a randomized clinical trial protocol designed to assess the effectiveness of the AAD and of nonpharmacologic management in improving clinical stability and reducing the readmission rate at 90 days in patients with HF.
Combining Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in CRT Treatment...
Heart FailureFor patients with advanced heart failure, Cardiac Resynchronization Therapy (CRT) has been a major improvement. The treatment improves symptoms and prolongs life in selected patients with heart failure. However, with the current selection criteria and methods for implanting the pacemaker, only 60-70% of the patients derive significant benefit from the treatment. New imaging techniques, including advanced ultrasound and computed tomography, in combination with new versatile multi-pole electrodes, have made an individually tailored therapy possible. Using these techniques in combination, the study will investigate the effect of individually based "optimal" placement of the pacemaker electrodes vs. standard care. The optimal LV electrode position is defined as pacing a viable segment with the latest mechanical delay, targeting a specific segment of the coronary sinus as visualised on cardiac CT. The hypothesis is that this will increase the number of positive responders from 65% to 85%.
Right Ventricular (RV) Pacing in Early Post-operative Continuous Flow Left Ventricular Assist Device...
Heart FailureContinuous right ventricular (RV) pacing demonstrates harm in patients with normal left ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart failure. However, little is known about RV pacing in patients with advanced heart failure treated with an implantable left ventricular assist device (LVAD). The univentricular support provided by contemporary continuous flow LVAD's has improved outcomes for many advanced heart failure patients, yet the incidence of RV failure in the early post-operative period following implantation is associated with significantly reduced survival and increased length of stay. Acute LVAD unloading of the left ventricle has adverse effects on RV shape and size that contribute to post-operative RV failure. By promoting RV synchrony, RV overdrive pacing may counteract these adverse mechanical alterations, improving RV systolic function and ultimately LVAD function. The investigators will recruit all patients referred for an implantable, continuous flow LVAD at Duke University Medical Center who have an existing implantable dual-chamber cardioverter-defibrillator. Patients will be prospectively randomized into two cohorts to compare continuous right ventricular pacing vs. native ventricular conduction at equivalent heart rates. Multiple clinical outcomes will be examined over a two week period post-operatively including invasive hemodynamics, vasoactive medication use, end-organ function, RV function by Echocardiography as well as patient symptoms and functional status.
Loop Diuretics Administration and Acute Heart Failure
Acute Heart FailureIntravenous loop diuretics is the therapy most commonly used to treat pulmonary congestion and systemic fluid overload. In theory, continuous infusion should allow for a more consistent diuresis, avoiding the sodium reabsorption in the distal tubule as well as the neurohormonal activation. This should lead to renal function improvement and BNP decrease.
Procalcitonin in Early Antibiotic Interruption in Patient With Bacterial Pulmonary infeCtion and...
Respiratory Tract InfectionsPneumonia2 moreIntroduction: Acute Heart Failure is frequently decompensated by pulmonary infection, but the diagnosis of pulmonary infection sometimes is difficult in these patients due to similar signals and clinical symptoms in both pathologies. Furthermore, when it is possible the diagnosis of pulmonary infection, physicians may have difficult to determine etiology and delaying antibiotic therapy. Procalcitonin (PCT) have been used like a biomarker to determine the period of use of antibiotics in patients with acute respiratory infections. It is specific for bacterial infections and it have showed as a marker of severity infection and may help to determine interruption period of antibiotic therapy in a safety way for the patient. Aim: Evaluate levels of PCT related to interruption of antibiotics in patients with decompensated acute heart failure (DAHF) with suspected bacterial pulmonary infection. Methods: In this pilot project will be included around 100 patients, randomized in two groups: group A (PCT levels may guide the interruption of antibiotic at day 5) or group B (antibiotic period will be determined by the physician without the knowledge of PCT levels). Will be collected laboratorial and clinical data at days 0,3 and 5. Both groups will be compared to evaluate PCT levels and total period of antibiotic therapy, hospitalization and readmission in 30 days. This study will determine the sensibility/specificity of PCT in patients with DAHF.
Product Design Clinical Performance Study of sc2Wear Furosemide Combination Product
Heart FailureThe proposed single-dose study aims to evaluate the product design clinical performance of the to-be-marketed drug-device combination product, the sc2Wear Furosemide Combination Product, in adult Subjects previously diagnosed with mild to advanced heart failure. The study drug formulation is a buffered Furosemide Injection Solution, 8 mg/mL, (total dose equals 80 mg/mL) administered subcutaneously for a total of 5 hours. The study device is the sc2Wear Furosemide Pump adhered to the body using medical grade adhesive. The objectives of this study are: To demonstrate that the to-be-marketed drug-device combination product performs as intended and delivers 80 mg of Furosemide subcutaneously in the abdominal area To assess safety and local tolerance of the drug-device combination product
Tolerability, Pharmacokinetics and Dopamine ß-hydroxylase (DßH) Inhibition Profile of BIA 5-453...
HypertensionChronic Heart FailureThe purpose of this study is to assess the safety and tolerability of BIA 5-453 after single oral doses
Mineralocorticoid Receptor Antagonists (MRA) in Heart Failure (HF) and Loop Diuretic Resistance...
Heart FailureThis is a prospective, single-center, double-blind and randomized placebo controlled trial for evaluation of a 7-day 100mg daily dose of spironolactone on weight loss and resolution of signs and symptoms of congestion in outpatients with acute decompensated heart failure (ADHF). Patients who are not responding to their current loop diuretics will be considered for this study. Mineralocorticoid receptor antagonists (MRAs) are recommended as standard of care in management of heart failure (HF) patients. However, recommended doses of MRAs (spironolactone 25mg/daily or eplerenone 50mg/daily) will not have any impact on signs and symptoms of volume overload. Therefore, the proposed study will aim to show the impact of this outpatient regimen to improve diuresis and possible reduction in hospitalization for further diuretic management in HF patients with signs and symptoms of congestion.
Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study
Heart FailureThe primary intent of this study is to assess the safety of the model 1457Q Quartet LV lead at 3 months in a patient population indicated for cardiac resynchronization therapy.
Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN
Chronic Heart FailureIron Deficiency1 moreThis study will address whether the additional use of Intravenous (IV) iron on top of standard care will improve the outlook for patients with heart failure and iron deficiency. One group of participants will receive treatment with iron injections and the other group will not receive any iron injections.