Active clinical trials for "Heart Failure"

Summary of the HF-HOPE study: Background and existing knowledge gap: As per the Canadian Chronic Disease Surveillance System, about 1 in 12 Canadian adults aged ≥20 live with diagnosed heart disease. Every hour, about 12 Canadian adults aged ≥20 die due to heart failure (HF). It is estimated that HF results in direct costs of more than $2.8 billion per year in Canada alone. As per the Canadian Society of Cardiology, heart failure is defined as "a complex clinical syndrome in which abnormal heart function results in, or increases the subsequent risk of, clinical symptoms and signs of reduced cardiac output and/or pulmonary or systemic congestion at rest or with stress". Although HF is defined as "reduced cardiac output state" no objective parameters are set to define the condition. Invasive monitoring is routinely used in hemodynamic evaluation of critically ill patients admitted in the hospital, however, there is no reliable tool available to measure hemodynamic parameters that may predict, immediate or long-term, risk of worst health outcomes in stable HF patients. We hypothesize that non-invasive bioimpedance-based hemodynamic parameters can be used as a predictive tool for health outcomes in patients with HF. To ascertain this, we propose the first of its kind HF-HOPE study. Objectives of HF-HOPE study are to 1) characterize hemodynamic measures of resting versus post-exercise (mounted ergometer) in patients with all-comer stable HF subjects, irrespective of their HF etiology using Non-Invasive Cardiac System (NICaS); 2) correlate NICaS-derived hemodynamic parameters to identify, early- and long-term risk of worse health outcomes (unplanned hospital admission due to HF or arrhythmias; listing for heart transplantation/palliative care; and death); 3) correlate the lean body mass (muscle and skeleton) with their body mass index (kg/m2) and the risk of worse health outcomes; and 4) Nested cohort study: identify the outcome-associated biomarkers of chronic HF by employing a non-targeted metabolomics/lipidomics approach. Methods: The HF-HOPE is a single center, prospective, double-blind, pragmatic clinical study. It will be conducted at St. Boniface general hospital, Manitoba's tertiary cardiac center. Patients aged ≥18 years, irrespective of any sex or gender, with confirmed diagnosis of HF will be enrolled in the study. Hemodynamic measurements (stroke volume, cardiac output, cardiac index, total peripheral vascular resistance, and cardiac power index) will be assessed using NICaS at 3-times (at rest in supine, siting position as well as after exercise on a mounted ergometer) at baseline and 6 months (±1 month) in each enrolled participant. Patients will be followed to record health outcomes as outlined above, each year. The BodPod, air displacement plathysmography device will be used to determine body compositions at baseline and 6-month. Baseline demographic data will be gathered. To optimize the use of clinical resources, we will collect blood and urine samples for non-selective metabolomics and lipidomics profiling by adopting -omics approach as a nested cohort study. Statistical analysis: Assuming the 8 to 12% 1-year mortality rate following admission with HF, a projected sample size of 500 would be suffice. Conservatively 4 covariates will be included in multivariable statistical models, while testing the independent effect of the relevant NICaS parameters of interest. We will perform subgroup analysis using age, sex, ethnicity, concomitant disease conditions, medications, and lean body mass. Anticipated outcomes and future implications: The HF-HOPE study is the first of its kind study employing non-invasive hemodynamic parameters to predict worsening health outcomes over time in HF patients. The successful outcomes will provide a promising cost effective, rapid, and reliable tool to predict worsening health outcomes before it actually lead to hospitalization, tissue damage or death. This early warnings will provide adequate time for appropriate intervention. The HF- HOPE study has been meticulously designed to replicate the pragmatic conditions while assessing the non-invasive hemodynamic measurements to widen the knowledge translation of outcomes to change the clinical practice of HF patient management. Further, this may provide supporting data for future randomized trial to replace the costly, resource-intense, and complex invasive tool to determine hemodynamic measurements in HF patients.

The investigators sought to evaluate the effectiveness of treatment with furosemide + HSS in terms of reduction of serum levels of some chosen markers of heart failure and the response in terms of these markers at a compensated state after an acute saline load.

The purpose of this research is to see if the drug rapamycin will improve the heart's ability to pump by improving your oxygen consumption.

Heart failure is a complex clinical syndrome manifesting as inability to supply adequate blood flow throughout the body due to any structural or functional cardiac abnormality. The most common complaints are exercise intolerance, balance, dyspnea, and fatigue in patients with heart failure. It is clearly stated that pulmonary muscle weakness is prevalent and contributes to exercise intolerance in patients with heart failure. Purpose of the study was to evaluate the efficacy of inspiratory muscle traning on pulmonary muscle strength, pulmonary function test, functional capacity and quality of life. The tools used were 6-minute walk test, spirometry, IMT threshold device for IMT strength, and Quality of life. Study was conducted in 20 patients in single group and pre and post values were evaluated. The significance this study bears was that it helped defining for us that to how much extent we can improve the physical and pulmonary functional capacity using inspiratory muscle training. Data were analysed using spss 22.0.mean and standard deviation were calculated. Appropirate the stasitical test were used after checking normailty of data. Parametric test were used for data analysis using SPSS 22

The 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 30 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 primary objective of the study is to estimate the absolute bioavailability of furosemide administered by subcutaneous infusion compared with an equivalent dose of furosemide administered by IV bolus administration.

The aim of this study is to utilize lung ultrasound to detect the development of extravascular lung water in patients undergoing clinically indicated invasive hemodynamic exercise stress testing for symptomatic shortness of breath. The study will correlate the lung ultrasound findings with cardiac hemodynamics and measurements of extravascular lung water in an effort to better understand the pathophysiology of exertional dyspnea.

This is a Phase I, randomized, double-blind, placebo-controlled study to assess safety, pharmacokinetics and pharmacodynamic parameters of CDR132L in patients with stable heart failure of ischemic origin (NYHA 1-3).

Recent exploratory studies suggest that pacemaker patients with diastolic dysfunction (DD) or heart failure with preserved ejection fraction (HFpEF) may benefit from a higher backup heart rate (HR) setting than the factory setting of 60 beats per minute (bpm). In this prospective double-blinded randomized controlled study, pacemaker patients with DD or overt HFpEF and either 1) intrinsic ventricular conduction or 2) conduction system or biventricular pacing will be enrolled and randomized to either a personalized lower HR setting (myPACE group, based on a height-based HR algorithm) or to the standard 60bpm backup setting (control group) for 1 year.

Single-center, prospective double-blinded randomized control trial to evaluate the the feasibility, efficacy and safety of outpatient IV diuretic therapy in treatment of heart failure.

Chronic heart failure (CHF) is one of the major causes of death in Western societies. Evidence has accumulated that functionally active autoantibodies directed against the beta1 adrenergic receptor (β1 AAb) are of pathophysiological relevance for the development and progression of cardiomyopathy and associated CHF. BC 007 is under development for targeted neutralisation of autoantibodies directed against G protein coupled receptors, including β1 AAb. This is an open label, three-centre, randomised phase 2a study in participants with chronic HFrEF. The study will evaluate whether BC 007 causes a persistent neutralisation of the β1 AAb demonstrated by a negative β1 AAb status up to 12 months. Participants will be randomised in a 2:1 ratio to the treatment arm (BC 007) or the control arm (untreated). Treatment is repeated once up to month 11 if the participant's β1 AAb were not neutralised after 1st dosing on day 1 or reoccur.