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Heart Failure, Congestive clinical trials

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NCT ID: NCT03621436 Recruiting - Clinical trials for Congestive Heart Failure

Clinical Evaluation of the TRVD™ System in ADHF

TRVD
Start date: August 7, 2015
Phase: N/A
Study type: Interventional

A prospective, multi-national, open-label clinical study which is conducted to asses the safety, feasibility and performance of the TRVD™ System in hospital-admitted patients with Acute Decompensated Heart Failure (ADHF) and evidence of reduced left ventricular ejection fraction. The study will include patients who present with significant venous congestion, as evidenced by clinical, laboratory and imaging signs of fluid retention. Study participation, for each enrolled subject, will last approximately 3 months post index procedure. Patients will be evaluated from enrollment until hospital discharge, then at 30, 60, and 90 days post procedure.

NCT ID: NCT03575910 Not yet recruiting - Heart Failure Clinical Trials

HEARTBiT: Multi-Marker Blood Test for Acute Cardiac Transplant Rejection

HEARTBiT
Start date: July 1, 2018
Phase:
Study type: Observational

Heart transplantation is a life saving therapy for people with end stage heart failure. Acute rejection, a process where the immune system recognizes the transplanted heart as foreign and mounts a response against it, remains a clinical problem despite improvements in immunosuppressive drugs. Acute rejection occurs in 20-30% of patients within the first 3 months post-transplant, and is currently detected by highly invasive heart tissue biopsies that happen 12-15 times in the first year post-transplant. Replacing the biopsy with a simple blood test is of utmost value to patients and will reduce healthcare costs. The goal of our project is to develop a new blood test to monitor heart transplant rejection. Advances in biotechnology have enabled simultaneous measurement of many molecules (e.g., proteins, nucleic acids) in blood, driving the development of new diagnostics. Our team is a leader in using computational tools to combine information from numerous biological molecules and clinical data to generate "biomarker panels" that are more powerful than existing diagnostic tests. Our sophisticated analytic methods has recently derived HEARTBiT, a promising test of acute rejection comprising 9 RNA biomarkers, from the measurement of 30,000 blood molecules in 150 Canadian heart transplant patients. Our objective is to study a custom-built HEARTBiT test in a setting and on a technology that enable clinical adoption. We will evaluate the new test on 400 new patients from 5 North American transplant centres. We will also track patients' HEARTBiT scores over time to help predict future rejection, and explore use of proteins and micoRNAs to improve HEARTBiT. Our work will provide the basis for a future clinical trial. The significance of this work rests in that it will provide a tool to identify acute cardiac rejection in a fast, accurate, cost-effective and minimally invasive manner, allowing for facile long-term monitoring and therapy tailoring for heart transplant patients.

NCT ID: NCT03573427 Recruiting - Clinical trials for Left Ventricular Dysfunction

LV Endocardial CRT for Patients With Intermediate QRS Width

EndoCRT
Start date: April 28, 2016
Phase:
Study type: Observational

This pilot study is designed as a multi-centre cohort study determining the degree of LV reverse remodeling in patients with intermediate QRS widths (120-149ms) who undergo CRT implant with transseptal LV leads, and comparing to the average expected reverse remodeling rate in patients with standard transvenous coronary sinus leads and QRS widths ≥150ms.

NCT ID: NCT03519477 Not yet recruiting - Clinical trials for Heart Failure,Congestive

Comprehensive Medication Monitoring on Heart Failure Patient Outcomes

Start date: July 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the clinical utility of comprehensive medication monitoring using the Patient Medication Profile to improve heart failure patient medication therapy and associated outcomes relative to usual care in a hospital setting.

NCT ID: NCT03497871 Recruiting - Clinical trials for Heart Failure, Congestive

Personal Decision Support System for Heart Failure Management

HeartMan
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Despite the availability of evidence-based guidelines for disease management in patients with congestive heart failure (CHF), the uptake of these guidelines in clinical practice is sub-optimal and adherence rates are disappointing. Within the HeartMan project, a personal e-health system was developed to help CHF patients manage their disease, with the ultimate goal to improve health-related quality of life (HRQoL). The system uses wrist-band sensors to monitor patients' physical activity and physiological parameters. These data are connected to a decision support system, providing medical advice to patients concerning physical exercise, nutrition, medication intake, clinical measurements, environment management, and mental support. The decision support system is based on predictive models, clinical care guidelines and expert knowledge. The advice will be personalized according to each individual patient's medical and psychological profile, and will be presented to the patient through the user interface of a mobile application on a smartphone. A proof of concept trial with a 1:2 (control:intervention) randomization protocol was designed. The sample size calculation was based on primary outcome data from the previous CHIRON project, showing that 90 patients are needed to show at least -5.8 (± 6 to 8 s.d.) beats/min difference in average daily awake heart rate difference - as a fundamental parameter correlating with patient reported HRQoL - with 90% power between the two groups. Data collection will include an estimation of exercise capacity based on a six-minute walking test, and questionnaire assessments using standardized instruments. The trial will be initiated in two countries. In order to account for possible dropouts, 60 patients will be enrolled in Italy and 60 in Belgium (20 control and 40 intervention patients in each country). Target patients are stable ambulatory CHF patients (NYHA class 2-3; reduced left ventricular ejection fraction ≤40%). Eligible patients will be recruited by their treating physician from collaborating medical centers in both countries; they will be enrolled in the trial after giving informed consent for participation. After baseline assessment, patients will be randomized into either the intervention (duration of 6 months) or control (usual care) condition. Data collection will be repeated at the end of the trial.

NCT ID: NCT03425422 Recruiting - Heart Failure Clinical Trials

ANTHEM-HFrEF Pivotal Study

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

A multi-center randomized controlled clinical trial to evaluate Autonomic Regulation Therapy with the VITARIA system in patients with symptomatic heart failure and reduced ejection fraction.

NCT ID: NCT03389386 Recruiting - Clinical trials for Heart Failure,Congestive

Plasma Catestatin Expression and Cardiometabolic Parameters in Patients With Congestive Heart Failure

CATSTAT-HF
Start date: January 25, 2018
Phase:
Study type: Observational

The congestive heart failure (HF) is a condition associated with substantial morbidity, mortality, and high healthcare expenditures. From the pathophysiological standpoint, several mechanisms contribute to the progression and dysfunction of the failing heart such as an increased hemodynamic overload, impaired myocyte calcium cycling, upregulated apoptotic activity, deficient or increased production of extracellular matrix, genetic predilections and, finally, excessive neurohumoral stimulation. The vasoactive neurohumoral systems such as sympathetic nervous system, renin-angiotensin-aldosterone system (RAAS) and arginine vasopressin (AVP) system all play a role in maintaining volume and circulatory homeostasis in the situation of impaired cardiac output. Catestatin (CST), on another hand, is a novel endogenous peptide cleaved from chromogranin A (CgA) that is involved in regulation of cardiac function and arterial blood pressure. The role of this peptide is to elicit potent catecholamine release-inhibitory activity by acting at the level of the nicotinic acetylcholine receptors. Therefore, the main hypothesis of this study is that the observed plasma CST levels will reflect the degree of neurohormonal activation in HF, showing a significant relationship with the degree of disease severity (according to NYHA classification). The investigators expect that among participants with worst clinical phenotypes of HF, CST levels in plasma will be highest and will decrease as the disease severity decreases. Secondly, the investigators expect to observe the significant correlation between CST levels in plasma with the echocardiographic parameters of the ventricular function, both in terms of systolic and diastolic cardiac function. Parameters of inflammation, NT-proBNP levels and basic hematologic/biochemistry indices from peripheral blood will also be obtained and analyzed from all the participants enrolled in the study. Furthermore, according to the latest European Society of Cardiology (ESC) guidelines, participants with established congestive HF will be prospectively stratified in three categories in respect to their left ventricular ejection fraction (LVEF) - HFrEF, HFmrEF, HFpEF. All the examined echocardiographic and blood parameters will be recorded and compared with respective healthy and matched control participants while participants diagnosed with HF will additionally be analyzed for potential differences between subgroups according to their LVEF value.

NCT ID: NCT03387813 Recruiting - Heart Failure Clinical Trials

Hemodynamic-GUIDEd Management of Heart Failure

GUIDE-HF
Start date: March 15, 2018
Phase: N/A
Study type: Interventional

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.

NCT ID: NCT03385837 Recruiting - Clinical trials for Cardiac Rehabilitation

Activity Level and Barriers to Participate of Cardiac Rehabilitation in Advanced Heart Failure Patients

Start date: March 1, 2015
Phase: N/A
Study type: Observational

A prospective longitudinal and observational clinical study will be conducted with hospitalized heart failure patients.The main purpose is to know the level of physical activity of these patients after their discharge in relation to the orientation received during their hospitalization and identify the barriers perceived by these patients to participate in a cardiac rehabilitation program. The outcomes are available by telephone calls in 30 and 90 days after discharge.

NCT ID: NCT03341156 Not yet recruiting - Clinical trials for Heart Failure,Congestive

Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation

OPSTAHT
Start date: June 20, 2018
Phase: Phase 3
Study type: Interventional

This study is comparing the use of Kcentra vs. standard transfusion in patients undergoing heart transplantation surgery. Half of the patients will receive Kcentra, while the other half will receive fresh frozen plasma.