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Heart Failure clinical trials

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NCT ID: NCT04696120 Not yet recruiting - Heart Failure Clinical Trials

Effects of APIXaban on BRAIN Protection in Patients With Sinus Rhythm and Heart Failure: APIXBRAIN-HF Trial

Start date: March 2, 2021
Phase: Phase 2
Study type: Interventional

objectives: The primary aim of APIXBRAIN-HF Trial is to explore the effects of apixaban on brain protection in patients with sinus rhythm and heart failure Primary / Secondary Endpoint 1. New occurrence of brain pathology 1) Cortical cerebral microinfarcts 2) Silent lacunar infarction 3)Progression of white matter hyperintensities 2. Secondary endpoint 1) The change of cognitive function evaluated by MMSE-2 2) Individual variable of primary endpoint 3. Safety Endpoint Evaluation 1) Cerebral microbleeds on imaging

NCT ID: NCT04695990 Not yet recruiting - Heart Failure Clinical Trials

Study on the Clinical and Mechanism of Wenyang Huoxue Decoction in Treating Heart Failure After Myocardial Infarction

Start date: January 15, 2021
Phase: Phase 2
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled, parallel clinical trial in a Chinese population with heart failure after myocardial infarction. The objective is to observe the efficacy and safety of Wenyang huoxue fang in the treatment of heart failure after myocardial infarction.

NCT ID: NCT04688827 Not yet recruiting - Heart Failure Clinical Trials

Impact of Additional Resistance Training During Rehabilitation Therapy in Patients With Heart Failure

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

The impact of moderate- or low-intensity resistance training will be investigated additional to endurance training in heart failure patients following rehabilitation. The aim is to optimize intensity of resistance training in this patient population.

NCT ID: NCT04667598 Not yet recruiting - Heart Failure Clinical Trials

Clinical and Metabonomics Study on the Treatment of Heart Failure After Myocardial Infarction With Modified Wenxin Decoction

Start date: December 15, 2020
Phase: Phase 2
Study type: Interventional

To elucidate the efficacy and safety of weixin decoction in the treatment of heart failure after myocardial infarction.

NCT ID: NCT04633629 Not yet recruiting - Acute Heart Failure Clinical Trials

LUS in Acute Heart Failure Therapeutic Adaptation

EPPICA
Start date: December 2020
Phase:
Study type: Observational

Evaluate lung ultrasound aspect according to diuretics dosage evolution in patients hospitalized for acute heart failure.

NCT ID: NCT04583813 Not yet recruiting - Obesity Clinical Trials

Empagliflozin and Atrial Fibrillation Treatment

EMPA-AF
Start date: September 2021
Phase: Phase 4
Study type: Interventional

The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation.

NCT ID: NCT04581252 Not yet recruiting - Heart Failure Clinical Trials

Heart Failure HemOdynamic Prognostic Evaluation and OutcomE (HF-HOPE) Study

HF-HOPE
Start date: November 1, 2020
Phase:
Study type: Observational

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.

NCT ID: NCT04570865 Not yet recruiting - Clinical trials for Heart Failure, Systolic

Dapagliflozin And Pulmonary Artery Hemodynamics in Heart Failure With Reduced Ejection Fraction Patients With CardioMEMS®

DAPA-MEMS
Start date: December 1, 2020
Phase: Phase 4
Study type: Interventional

The focus of this study is to investigate the use of Dapagliflozin in HFrEF (NYHA II-IV) patients with or without diabetes who have CardioMEMS® implanted to assess the impact on pulmonary artery pressure measurements after 12 weeks of therapy.

NCT ID: NCT04538469 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff

VINCI
Start date: September 2020
Phase:
Study type: Observational

Patients are part of a family network. When any person in a family becomes critically unwell and requires the assistance of an Intensive Care Unit (ICU), this has an impact on all members of that family. COVID-19 changed visiting for all patients in hospitals across Scotland. It is not known what effect these restrictions will have on patients' recovery, nor do we understand the impact it may have on their relatives or staff caring for them. This study will look at the implications of the visiting restrictions as a consequence of the COVID-19 pandemic upon patients without COVID-19 who are in the cardiothoracic ICU. It will also explore the impact of these restrictions on them, their relatives and staff. This study will be carried out within a single specialised intensive care unit in Scotland using mixed methods. The first arm of this study will use retrospective data that is routinely collected in normal clinical practice. The investigators will compare patient outcomes prior to COVID-19 with outcomes following the implementation of COVID-19 visiting restrictions. The aim is to establish if the restrictions on visiting has an impact on the duration of delirium. Delirium is an acute mental confusion and is associated with longer hospital stays and worse outcomes in this patient group. The second arm of this study involves semi-structured interviews with patients, relatives and staff that will allow deeper exploration of the issues around current visiting policy. The interviews will last approximately 1 hour and will address these issues. They will then be transcribed word for word and analysed using grounded theory, meaning the theories will develop from the data as it is analysed.

NCT ID: NCT04500938 Not yet recruiting - Clinical trials for End-stage Heart Failure

Cardiac Mitochondrial Function in Explanted Human Hearts

Start date: August 30, 2020
Phase:
Study type: Observational

Background: Treatment of heart failure has improved considerably in the past decades. Despite this improvement, the disease may progress into an end-stage ultimately leaving the physicians with no other treatment option than heart transplantation (HTx). There are multiple etiologies underlying heart failure. Cardiomyopathy is the leading cause for HTx in any age-group with coronary artery disease being the second most common cause in adult patients. Alterations in the mitochondrial function have been recognized as key factors in heart failure. During the transplant procedure the diseased heart is removed, providing a unique opportunity to collect samples eligible for thorough mitochondrial examination. Hopefully, the knowledge gained from this investigation will contribute with important insights in the diseased myocardial energy metabolism. Such knowledge may pave the way for development of treatments targeting both energy substrate supply for adenosine-triphosphate generation produced by the mitochondria as well as mitochondrial function in the failing heart. Hypothesis: The pathological myocardial function seen in heart failure is related to dysfunctional cardiac mitochondria Objective: To examine if cardiac mitochondrial function in end-stage heart failure of multiple etiologies is inferior to mitochondrial function in transplanted hearts with no signs of rejection or vasculopathy. Design: Myocardial mitochondrial function analyzed from 24 explanted hearts will be compared to endomyocardial biopsies from 20 HTx patients at scheduled biopsies (1 or 2 years after implantation).