View clinical trials related to Heart Failure.
Filter by:The 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
The proposed pilot study aims to gain experience with the first clinical use of the to-be marketed drug-device combination product, the sc2Wear Furosemide Combination Product and to assess methods and procedures for evaluation of product performance. The objectives of this study are: - To gain first in man experience of a novel drug-device combination product - To evaluate the suitability of the methods and procedures for evaluating of the performance of the sc2Wear Pump
Some patients with heart failure require treatment called cardiac-resynchronisation therapy (CRT) which involves putting a pacemaker into the heart to make both ventricles (the lower chambers of the heart) contract together, making the pumping of the blood to the rest of the body more efficient. it is important to get the CRT pacemaker checked to make sure that it is working correctly and performing its job. However, it can be difficult to adjust the settings of the pacemaker just the right amount to ensure the heart is pumping efficiently. One of the ways this can be done is by using a special machine which uses ultrasound to make a 2-dimensional image of the heart called an echocardiogram. This technique can also be used to measure the flow of blood in the heart and calculate how efficient it is at pumping blood. However adjusting the settings of the pacemaker with this device is difficult to use and time consuming. Electrocardiogram (ECG) a 2-dimensional electrical tracing of the hearts activity is another tool used to help adjust the settings of pacemakers, to make the heart pump more efficiently. Furthermore, recent research has shown that this is better than echocardiogram at optimising pacemaker device settings. A new type of ECG called cardiogoniometry (CGM) has recently been developed which creates a 3-dimensional view of the hearts electrical activity and has already been shown to be better than normal ECG at diagnosing certain conditions like angina and heart attacks. However it has never been used to try optimise the settings of the pacemakers used in CRT and may be quicker and easier to use than then other methods available. More importantly it is hoped by doing this it will reduce the symptoms that patients suffer as it is making the heart pump more efficiently. As it has been untested and never used in this setting before, and there it is necessary to find out if the CGM machine will recognise when the settings on the pacemaker are changed. The aims of this study is to see if the CGM machine can pick up changes to pacemaker settings, with the hope of running a later study to see if it can be used to optimise settings on the pacemaker used in CRT.
Cardiac resynchronization therapy (CRT) is a well established clinical therapy for patients with symptomatic left ventricular systolic dysfunction and electrocardiographic QRS duration of 120 ms or greater. Multicenter trials have consistently demonstrated CRT "non responder" rates of 32-43% at 6 months. Subsequent studies have shown that utilizing echocardiographic-guided device reprogramming for optimal atrio-ventricular (A-V) and interventricular (VV) delays at rest have improved clinical response. Recently, an echocardiographically validated automated pacemaker programmer-based intra-cardiac electrogram (IEGM) algorithm has been developed for rapid optimization of sino-ventricular (P-V), A-V and V-V delays at resting heart rates that is partially based on the interventricular conduction time delays. Nevertheless, controversy still persists as to the applicability of both echocardiographic and IEGM derived algorithms at elevated heart rates, as with physical activity, when patients are more likely to experience symptoms related to poor cardiac output. Recent studies have shown clinical benefits of pacing from sites of late intrinsic activation or intra-ventricular conduction delays (IVCD). Some studies have utilized the intrinsic SENSED IVCD method while others used the right ventricle (RV)-PACED IVCD. There have not been any studies to date that compare both methods to determine if one may yield a better clinical outcome with lower non-responder rates. This study predicts that the RV paced IVCD method will provide better clinical outcomes than the longest RV sensed IVCD as determined by the clinical composite score. The study is a prospective double blind study with an additional cross-over group consisting only of non-responders to compare the clinical response in 72 patients receiving CRT therapy. After successful CRT-D implantation and before hospital discharge patients will be randomly assigned in a 1:1 fashion to Group 1 (SENSED) or Group 2 (PACED). The patient will complete a Minnesota Living with Heart Failure questionnaire, compare echocardiographic data and be assessed by a blinded nurse and physician prior to discharge and at each follow up visit to maintain the double blind design. After 3 months of follow-up, non-responders from each group will be crossed-over to the other group and followed for an additional 3 months. Clinical data will be collected at the end of that 3 months and compared looking at changes in symptoms, ejection fraction (EF) and other echocardiographic measurements, New York Heart Assocation Function Class ( NYHA) class, clinical composite scores (CCC), device interrogation data and hospital admissions between the two groups to see if there is a statistical difference.
This is a study to find out whether cardiac rehabilitation is feasible in Western Kenya. This study will test whether cardiac rehabilitation is feasible by measuring how many participants are able to follow and complete two different exercise protocols; one at home and one in hospital. It will also measure how the exercise intervention affects quality of living, depression and improvement in exercise tolerance.
In the Middle East and the Gulf, the general population have high cardiovascular risks like diabetes, hypertension, smoking and obesity. The average age of a patient with an acute coronary syndrome (ACS) event is relatively young compared to Western populations. Women are multiparous and the rates of consanguinity marriages are high in this region of the world. These risk factors and conditions result in heart failure. Great deal of knowledge is missing regarding the influence of these risk factors on heart failure presentation, the causes and management of heart failure in ambulatory patients in this region of the world.
The aim of the study is to explore association between increased central venous pressure, Ejection Fraction and renal dysfunction (eGFR) in patients with Cardio-Renal Syndromes type 1 and 2. The pilot study was set to provide the expected correlation coefficient for a sample size determination of the subsequent study.
Heart failure is a major health care burden. It can occur with either normal or reduced LV ejection fraction, depending on different degrees of ventricular remodelling. The investigators recently published a new method, curvedness-based imaging. The investigators have also reported the diagnostic utility of curvedness-based imaging in various cardiac diseases. The investigators now propose to prospectively assess curvedness-based imaging for diagnosis of heart failure with normal ejection fraction and with reduced ejection fraction, and examine left ventricular systolic and diastolic function and predicts the prognosis in a cohort of HF patients.
This proposed study aim to: 1. Determine intra-LV pressure-time profile non-invasively using recently developed echo Doppler VFM analysis and applanation tonometry and myocardial elastic properties, in HF subjects (both HFNEF and HFREF) compared to normal volunteers. 2. Correlate calculated intra-LV pressure parameters with NT ProBNP levels.
To build on Singapore's competitive advantages in advanced cardiac imaging, genetic and molecular studies to develop an integrated "one -stop" platform spanning from human to large and small animal models, dedicated to deepening the understanding of CV disease progression, discovery of new targets and repurposing of drugs.