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694 active trials for Heart Failure

Effectiveness and Implementation of the Assessment of Burden of Chronic Conditions (ABCC)-Tool

This study is designed to evaluate the effectiveness and implementation of the Assessment of Burden of Chronic Conditions (ABCC)-tool for patients with COPD, asthma, diabetes mellitus type 2 or heart failure (and any combination of these conditions) in real-life routine practice. The ABCC-tool consists of a questionnaire, a visualisation using balloons that is based on cut-off points, and treatment advice. The ABCC-tool is intended to be used in daily healthcare practice, is designed to monitor a patient's integrated health status over time, to facilitate shared decision making, and to stimulate self-management. The study has a pragmatic clustered quasi-experimental design with two arms. The intervention group will use the ABCC-tool and the control group will receive usual care. The study will be implemented at a general practice-level, and has a follow-up period of 18 months. The primary outcome is change in perceived quality of care, as measured with the Patient Assessment of Chronic Illness Care (PACIC), as compared to usual care after 18 months. It is hypothesized that the change in perceived quality of care is significantly higher in the group using the ABCC-tool as compared to the group that receives usual care. Additionally the implementation of the ABCC-tool in general practices will be evaluated in 12 general practices. The implementation study will evaluate the context of caregivers with the Consolidated Framework for Implementation Research, the process of implementation with the RE-AIM framework, and fidelity to the intervention with the fidelity framework.

Maastricht, LimburgStart: October 2019
Mechanical Dyssynchrony as Selection Criterion for CRT

Previous experience with cardiac resynchronization therapy (CRT) candidates suggests that selection of these patients can be improved. Current clinical guideline approaches are mainly too unspecific and lead to a high non-responder rate of 30-40%, which causes a burden on health care systems and puts patients at risk of an unnecessary treatment who might benefit more from a conservative approach. Previous work indicated that using the assessment of mechanical dyssynchrony on echocardiography can lower the non-responder rate at least by 50% without compromising sensitivity for detecting amendable patients. The current prospective, randomized, multi-center trial was therefore designed to prove that the characterization of the mechanical properties of the left ventricle can improve patient selection for CRT. Patients will be randomized into one of two study arms: a control study arm with treatment recommendation based on clinical guidelines criteria, or an experimental study arm with treatment recommendation based on the presence of mechanical dyssynchrony. All patients will receive a CRT implantation. In the control study arm, bi-ventricular pacing will be turned on. In the experimental study arm, bi-ventricular pacing will be turned on or off, depending on the presence or absence of mechanical dyssynchrony, respectively. The primary endpoint will be non-inferiority in outcome of a treatment recommendation based on mechanical dyssynchrony, achieved with a lower number of CRT devices implanted, effectively leading to a lower number needed to treat. Outcome measures are the average relative change in continuously measured LVESV per arm and the percentage 'worsened' according to the Packer Clinical Composite Score per arm after 1 year follow-up.

LeuvenStart: October 2020
Assessing Systemic Circulation and LV Performance in Adults

Background There are significant limitations in the current approaches to assessing 2 important areas of cardiovascular physiology - the systemic circulation and left ventricular (LV) performance. The investigators' have repurposed the concepts of "systemic vascular conductance" to assess systemic circulation, and the "head capacity principle" to assess LV performance. The investigators' now seek to test these concepts in human adults, with heart failure and without heart failure, using non-invasive methods. Hypothesis There will be a depressed head-capacity curve and reduced power among patients with heart failure which will indicate compromised left ventricular pump function. Methods The research study will involve a single outpatient visit per subject. The study will take place with the subject supine on a bed/table. The subjects will be instrumented with EKG electrodes and finger blood pressure cuffs. The continuous finger BP device performs a waveform analysis in real-time to determine the non-invasive stroke volume, cardiac output, and blood pressure. The patient will be supine for at least 5 minutes to collect baseline data before being handed a dynamometer device. The subject will then be asked to squeeze the dynamometer with maximum force for a minimum of 2 minutes while only engaging their forearm and remaining relaxed in the rest of their body. The subject will then release the dynamometer and remain supine, in recovery, for a minimum of 5 minutes. Following the handgrip test, the instrumentation will be removed and the patient's participation in the study will be complete. The study duration should be about 20 min.

Calgary, AlbertaStart: September 2021
Type 2 Diabetes With Antiplatelet Drugs Retrospective Analysis

Tabula Rasa HealthCare (TRHC), d/b/a CareKinesis, is the first national pharmacy that provides science-based medication risk identification and mitigation technologies and services. CareKinesis utilizes medication decision support tools and pharmacists certified in geriatrics to provide pharmacy services for various healthcare organizations including PACE organizations (described above). Presently, CareKinesis services more than 35 PACE organizations, including approximately 140 PACE sites, across the country. As a national PACE pharmacy provider since 2011, CareKinesis focuses on improving medication regimens to reduce medication-related risks while enhancing economic, clinical and humanistic outcomes. Pharmacist-led clinical services and medication safety reviews are currently being offered to PACE organizations under the direction of licensed healthcare prescribers by TRHC (CareKinesis). Through mutual data-sharing agreements, patient data will be collected retrospectively for patients satisfying the inclusion and exclusion criteria. TRHC via other programs such as the Center for Medicare & Medicaid Enhanced Medication Therapy Management program with BlueCross BlueShield Northern Plain Alliance and ClearStone, or via collaboration as third party with other health plans can have access to de-identified patient's data. TRHC has also established an agreement with the Watson IBM database to retrieve relevant patients' information for research.

Orlando, FloridaStart: October 2021
Breathing Exercise Against Dyspnoea in Heart Failure Patients to Improve Chemosensitivity

An exaggerated ventilatory response (minute ventilation, V̇E) to exercise relative to exhaled carbon dioxide (V̇CO2) is common in heart failure (HF) patients with reduced as well as preserved left ventricular ejection fraction (HFrEF, HFpEF). Severity of this exaggerated response is associated with poor prognosis. This response may be triggered by pulmonary congestion and peripheral muscle myopathy. A vicious circle is fuelled by hypersensitivity of chemoreceptors to hypercapnia and sympathetic nervous hyperactivity, resulting in hyperventilation (low PaCO2). Low PaCO2 is predictive of mortality in these patients. PaCO2 can be increased acutely, e.g. by apnoea. Also, nasal breathing has been found to reduce the V̇E/V̇CO2 slope during exercise compared to oral breathing. Three previous slow breathing studies in HFrEF patients have had encouraging results with regard to reducing sympathetic activity, reflected in lowered arterial (pulmonary) blood pressure and increased EF. The investigators hypothesise that a 12-week training with nasal slow breathing followed by end-expiratory apnoea based on education, centre-based introduction and home-based 15 min/day breathing training will be effective at reducing the exaggerated ventilatory response to exercise. A total of 68 patients with stable HF seen at the HF clinics of the Inselspital (34 HFrEF, 34 HFpEF) will be randomised to the breathing intervention or usual care. Primary outcome will be V̇E/V̇CO2 slope at 12 weeks. If breathing training successfully ameliorates the exaggerated ventilatory response and perception of dyspnea during exercise, it offers an attractive tele-health based add-on therapy that may add to or even amplify the beneficial effects of exercise training.

BerneStart: October 2021