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Heart Failure clinical trials

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NCT ID: NCT03836482 Suspended - Clinical trials for Cardiorenal Syndrome

Selective Cytopheretic Device (SCD) Trial

Start date: November 11, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the selective cytopheretic device on the immune dysregulated state of congestive heart failure(CHF) with CRS and to assess the benefit of the device to improve cardiovascular and renal function. The study will enroll eligible patients in the ICU with acute on chronic systolic heart failure and worsening renal function due to cardiorenal syndrome while awaiting LVAD implantation. In this study patients who are eligible and agree to participate will receive treatment with the SCD. The treatment will be for 6 hours a day up to 6 days. Additionally, participants will have additional study procedures and be evaluated to determine if their kidney function improves enough to undergo LVAD implantation.

NCT ID: NCT03804606 Suspended - Heart Failure Clinical Trials

Risk and Benefit Informed MTM Pharmacist Intervention in Heart Failure

Start date: February 28, 2019
Phase: N/A
Study type: Interventional

Out-of-hospital care of complex diseases, such as heart failure, is transitioning from an individual patient-doctor relationship to population health management strategies. As an example, at our institution, medication therapy management (MTM) pharmacists are being deployed to patients with heart failure with the intent of improving patient outcomes (through proper medication management and adherence) while reducing cost (e.g., keeping these patients out of the hospital). The success of such strategies will be dependent on the ability to effectively direct scarce resources to deliver appropriate/needed care to patients. In this prospective, pragmatic randomized and matched controlled study, the investigators hypothesize that the combination of accurate, data-driven benefit models and MTM pharmacist intervention in patients with heart failure will result in reduced 1-year mortality and hospital admissions. Using our extensive historical electronic health record data, the investigators have developed a machine learning model that, for individual patients with heart failure, predicts risk and benefit (that is, reduction in risk) associated with closing specific "care gaps". These care gaps represent standard evidence-based treatments that may be missing for an individual patient, such as beta blockers or flu shots. The investigators will use this model to define three cohorts to be studied: 1) a high risk/high benefit group to be referred for MTM pharmacist intervention, 2) a high risk/high benefit group to continue with existing standard of care (not necessarily involving MTM pharmacy), and 3) a high risk/low benefit group to be referred for MTM pharmacist intervention. Comparison of groups 1 and 2 (for which assignment is randomized) will evaluate the effectiveness of the MTM pharmacy intervention, while comparison of groups 1 and 3 will evaluate the accuracy of the benefit model prediction and importance of appropriate patient selection for treatment. The primary study outcomes will be mortality and number of hospital admissions during 1-year follow-up following study enrollment.

NCT ID: NCT03755570 Suspended - Heart Failure Clinical Trials

How is COGNItive Function Affected by Cardiac Resynchronisation Therapy?

COGNI-CRT
Start date: June 21, 2019
Phase:
Study type: Observational

The primary objective of COGNI-CRT is to assess whether Cardiac Resynchronisation Therapy (CRT) can improve cognitive function in patients with systolic HF (LVEF ≤35%), when compared to a control group of patients implanted with an Implantable Cardioverter-Defibrillator (ICD) or a permanent pacemaker (PPM) with systolic HF (LVEF ≤35%). This clinical investigation is a prospective, single-centre cohort study. Each participant will be followed for 6 months. The study will collect data over 3 years; 2.5 years for enrolment and 6 months until the last participant completes the last 6-month follow-up visit. N.B: COGNI-CRT does NOT affect the patient's care pathway - the patients who will be selected for participation are those who have already been referred for the device implant. The ONLY difference to the patient's care pathway caused by COGNI-CRT is the addition of a battery of cognitive function tests, which involves asking the patient questions and asking them to complete questionnaire-like cognitive tests. NTpro-BNP levels, NYHA classification and LVEF will be measured prior to device implantation and at 6-months post-implant to assess the device's impact on the participant's heart failure (and CRT response). N.B: NT-proBNP, NYHA classification and LVEF are all parts of the patient's standard care pathway, COGNI-CRT is just utilising the data collected as part of the investigation. The main study arm and control group allows COGNI-CRT to assess 3 potential outcomes for patients with severe HF (LVEF <35%): 1. Cognitive function is not improved by CRT, ICDs or PPMs 2. Cognitive function can be improved by the assurance of rate control offered by CRT, ICDs and PPMs 3. Cognitive function can be improved by the assurance of ventricular synchronisation and rate control provided by the additional left ventricular lead in CRT devices.

NCT ID: NCT03736421 Suspended - Septic Shock Clinical Trials

Observational Study to Evaluate Peripheral IntraVenous Analysis (PIVA) in Euvolemic, Hypovolemic, and Hypervolemic Emergency Department Patients

PIVA
Start date: November 10, 2018
Phase:
Study type: Observational

The overall goal of this multicenter project is to characterize the expected normal range of Peripheral IntraVenous Volume Analysis (PIVA) values during a euvolemic state, and how those ranges may be altered by comorbidities; the relationship between PIVA and intravenous volume administration during resuscitation of infected patients with presumed hypovolemia; and, the relationship between PIVA and volume decreases during diuresis in acute heart failure patients with hypervolemia.

NCT ID: NCT03647891 Suspended - Heart Failure Clinical Trials

Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized Cardiac Patients

CV Readmit
Start date: July 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether early diagnosis of obstructive sleep apnea and initiation of and adherence to CPAP therapy in hospitalized cardiac patients would impact 30-day hospital readmission rates.

NCT ID: NCT03180450 Suspended - Heart Failure Clinical Trials

The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-HF)

Start date: December 31, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating heart failure patients

NCT ID: NCT03159988 Suspended - Clinical trials for Cognitive Impairment

Angiotensin (1-7) Treatment to Improve Cognitive Functioning in Heart Failure Patients

Start date: April 2016
Phase: Phase 2
Study type: Interventional

Heart failure (HF) is the major cardiovascular disease that continues to grow in prevalence, largely due to aging of the population. HF is described as the inability of the heart to keep up with the demands on it and, specifically, failure of the heart to pump blood with normal efficiency. Cognitive impairment (CI) is common in HF patients, resulting in a person having trouble remembering, learning new things, concentrating, or making decisions that affect their everyday life. Patients with HF have been show repeatedly to have trouble remembering and learning new things when compared to the general population. Patients with demonstrated CI have a significantly increased risk of developing dementia (memory loss). It is believed that the reason HF patients have a higher risk of CI is possibly due to less blood reaching the brain and an overall inflammatory process occurring in the body including the brain. To date there are no known therapies that can help treat CI caused by HF. A substance, Angiotensin-(1-7) [Ang-(1-7)], is known to decrease inflammation in the brain. Early studies in humans have shown it to be safe. This substance is naturally produced in the body and works by activating areas in the brain involved in memory. Investigators believe that Ang-(1-7) may be able to help lower the risk of loss of cognitive function in patients with heart failure. In this study, we will try to determine whether Ang-(1-7) is a safe and effective treatment for cognitive impairment in HF patients.

NCT ID: NCT02962973 Suspended - Clinical trials for Advanced Heart Failure

European Clinical Evaluation of the Carmat Total Artificial Heart

ADVANCEHF
Start date: September 2016
Phase: N/A
Study type: Interventional

The objective of this clinical investigation is to evaluate the safety and performance of the Carmat Total Artificial Heart (TAH) in subjects with advanced heart failure requiring biventricular support. Each subject receiving the Carmat TAH will be evaluated at 6 months (180 days) for primary and secondary endpoints with further follow-up assessments up to 2 years. The results of the study will be used to support a CE mark application.

NCT ID: NCT02662439 Suspended - Heart Failure Clinical Trials

Bioimpedance Analysis in Chronic Heart Failure

Start date: February 2016
Phase: N/A
Study type: Interventional

The aim of this study is to investigate whether the objective measurement of fluid overload by bioimpedance analysis (Body Composition Monitor-BCM) in patient with acute decompensated heart failure would improve the diuretic therapy.

NCT ID: NCT02545582 Suspended - Clinical trials for Congestive Heart Failure

VITARIA Registry Study

Start date: August 2015
Phase: N/A
Study type: Observational [Patient Registry]

This registry will observe patients with symptomatic heart failure with implantable vagus nerve stimulation to provide insights into safety and efficacy during clinical routine.