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Heart Failure clinical trials

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NCT ID: NCT04971993 Terminated - Clinical trials for Heart Failure NYHA Class III

Step and Walking Pattern From Cardiac Monitor Study

SWAN
Start date: January 5, 2022
Phase:
Study type: Observational

To understand the feasibility of characterizing walking patterns in heart failure subjects and subjects at risk for arrhythmias using an investigational wearable monitor called the SWAN study system.

NCT ID: NCT04970953 Terminated - Clinical trials for Heart Failure With Preserved Ejection Fraction

Diastolic Exercise Stress Testing in Heart Failure

DEST-HF
Start date: August 9, 2021
Phase:
Study type: Observational

Patients with an intermediate risk (HFA-PEFF score 2-4 points) for heart failure with preserved ejection fraction (HFpEF) will be further investigated with invasive right heart catheterization. All patients with a resting pulmonary artery wedge pressure (PAWP) <15mmHg will undergo the following stress test modalities in a randomized order: (1) bicycle ergometry, (2) dynamic handgrip exercise, (3) 500ml fluid challenge over 5 minutes, (4) leg raise testing. Exercise induced HFpEF will be diagnosed if PAWP rises to >25mmHg.

NCT ID: NCT04970888 Recruiting - Aging Clinical Trials

Comparing the Effects of Cognitive Training and Physical Exercise on Cognition, Cerebral Autoregulation and Cerebral Vasoreactivity in Men and Women With Heart Failure

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

The objective of this project is to assess the effects of combined physical exercise and cognitive training interventions on cognitive and brain health in patients with heart failure (HF). Also, the role of sex on the effects of the interventions will be assessed.

NCT ID: NCT04970238 Enrolling by invitation - Heart Failure Clinical Trials

Effect of Levosimendan on Left Ventricular Systolic Function and Heart Failure After PCI in Patients With Acute Anterior Myocardial Infarction

Start date: October 2021
Phase: Phase 4
Study type: Interventional

Reperfusion therapy for acute ST segment elevation myocardial infarction (STEMI) can significantly reduce mortality, but patients may still have heart failure and adverse cardiovascular events due to massive myocardial loss. About 20% of patients present with acute heart failure (AHF) at admission, It is the most important cause of hospital death in acute myocardial infarction. Because of the large necrotic area of acute anterior myocardial infarction, heart failure still occurs in a considerable number of patients even after revascularization (PCI). Myocardial protection of ischemic myocardium is a hot topic in clinical research. Both ESC and Chinese heart failure guidelines recommend levosimendan for the treatment of acute decompensated heart failure. A large number of studies have proved that levosimendan can significantly reduce myocardial injury and improve cardiac function in patients with acute STEMI complicated with left ventricular dysfunction and cardiogenic shock compared with placebo. Basic research has confirmed that levosimendan can reduce the myocardial infarction area after acute coronary occlusion, improve the left ventricular function, and exert the effects of anti myocardial ischemia, myocardial injury, myocardial fibrosis, ventricular remodeling and anti apoptosis. However, there is still a lack of early preventive application of levosimendan in acute anterior myocardial infarction after PCI to improve ventricular remodeling and reduce the incidence of heart failure. The purpose of this study was to investigate the effect of early prophylactic levosimendan on left ventricular remodeling, ischemic myocardial protection and the development of heart failure in patients with acute anterior myocardial infarction after PCI.

NCT ID: NCT04967443 Completed - Hypertension Clinical Trials

Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer for Prazosin Hydrochloride Capsules

Start date: September 22, 2021
Phase: Phase 1
Study type: Interventional

Prazosin hydrochloride (HCl) is an oral anti-hypertensive indicated for the treatment of primary and secondary hypertension and heart failure. Pfizer Inc. is the marketing authorization holder for prazosin HCl oral capsules and intended to transfer drug product manufacturing operations from Pfizer, Barceloneta Puerto Rico to Pfizer Pharmaceutical, Ascoli, Italy. To support the manufacturer site transfer and process changes, this bioequivalence (BE) study is being conducted. This study will be a 2 Cohort, open-label, randomized, single dose study in healthy adult male and/or female participants. Cohort 1 will be crossover with 3 treatments, 3 periods, 6 sequences. Cohort 2 will be crossover with 2 treatments, 2 periods, 2 sequences. Primary objective of this study is demonstrate bioequivalence between prazosin HCl 1, 2 and 5 mg capsules manufactured at Ascoli versus prazosin HCl 2 and 5 mg capsules manufactured at Barceloneta under fasting conditions in healthy adult participants. Approximately 36 participants will be enrolled in each Cohort 1 and Cohort 2. Pharmacokinetic and statistical analysis will be performed for prazosin. Data from 2 Cohorts will be analyzed separately. The PK parameters area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast), and from time zero extrapolated to infinite time (AUCinf), maximum plasma concentration (Cmax), time to first occurrence of Cmax (Tmax), and terminal phase elimination half-life (t½) will be summarized descriptively by analyte and treatment. For primary objective, bioequivalence of the Test treatment relative to Reference treatment will be concluded if the 90% confidence intervals (CI) for the ratio of adjusted geometric means of Test treatments relative to Reference treatment for AUCinf (if data permit), AUClast and Cmax, fall wholly within (80%, 125%).

NCT ID: NCT04966442 Completed - Heart Failure Clinical Trials

GrandAides; a Workforce Innovation to Address Post Acute Care

Start date: April 1, 2014
Phase: N/A
Study type: Interventional

Randomized controlled trial with two groups looking at post hospital care for patients who were admitted with congestive heart failure. The control group includes standard of care provided to the patients after discharge including a hospital employed community health worker. The intervention group receives a specially trained GrandAide following the GrandAide model for post acute care. Difference in ER visits and readmissions was measured.

NCT ID: NCT04966104 Active, not recruiting - Heart Failure Clinical Trials

ODYSSEE-vCHAT Pilot Trial for Heart Failure

ODYSSEE-vCHAT
Start date: October 25, 2021
Phase: N/A
Study type: Interventional

INTRODUCTION Psychological distress and reduced quality of life are prevalent within the heart failure (HF) population. The 1-year rehospitalization (40%) and 5-year mortality (45% for women and 60% for men) rates are high. International task force committees report that medical therapy combined with counselling for HF self-care optimizes clinical outcomes. HYPOTHESES At trial completion (median = 8.5 months, range = 2 to 15 months), ODYSSEE-vCHAT versus enhanced usual care (eUC) is predicted to reduce morbidity and mortality rates. Greater engagement with the digital program is also predicted to be linked with improved self-reported mental and physical health at months 4, 8, and 12 and trial completion. RECRUITMENT HF patients who are at least 18 years old were recruited from the University Health Network (UHN), Sunnybrook Hospital, Mount Sinai Hospital, and the community. Accrual of the sample (N = 61) occurred over 13 months. DESIGN ODYSSEE-vCHAT is a double-arm, parallel-group, randomized, controlled (real-world) pilot trial with assessments at baseline, months 4, 8, and 12, and trial completion (median = 8.5 months, range = 2 to 15 months). It is a single-blind trial, with research personnel blinded (excluding the research coordinator). All patients were provided with free access to their respective digital intervention, ODYSSEE-vCHAT or eUC. Subjects were invited by weekly emails to participate in the resources available to their group. eUC patients were provided with access to educational materials for HF self-care that are available to the public on professional heart health websites. Participation in supplementary programs that provide HF self-care education was not restricted, rather it was monitored by self-report during assessments and will be statistically controlled for during outcome assessments. ANALYSIS Separate generalized linear models (GLMs) will evaluate ODYSSEE-vCHAT versus eUC for primary and secondary outcomes. GLMs will be adjusted for baseline assessments and potential covariates. Interactions between treatment arm and gender will be examined for each outcome, using Bonferroni post-hoc comparisons for relevant subgroups. Significance in all tests will be p < 0.05, 2-sided.

NCT ID: NCT04965623 Recruiting - Heart Failure Clinical Trials

ExplorATory Study oF the EdWards Transcatheter Atrial Shunt System (AlT FloW Germany)

AlT-FloW
Start date: February 22, 2021
Phase: N/A
Study type: Interventional

The Exploratory Study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.

NCT ID: NCT04964817 Terminated - Clinical trials for Heart Failure With Preserved Ejection Fraction

HFpEF and Symptomatic Obstructive Iliofemoral Venous Disease Study

PERSUADE
Start date: August 3, 2021
Phase:
Study type: Observational

To ascertain the potential symptom improvement assessed by Cardiopulmonary Exercise Testing (CPET) in subjects with heart failure with preserved ejection fraction (HFpEF) and nonthrombotic iliofemoral venous lesions and/or iliocaval obstruction defined by MR or CT venography AND CEAP Clinical Category ≥3 prior to venous stenting.

NCT ID: NCT04962763 Recruiting - Clinical trials for To Search for Biomarkers Associated With Ischemic Heart Failure

Correlation of Intestinal Flora and Metabolomics in Patients With Ischemic Heart Failure

Start date: June 30, 2021
Phase:
Study type: Observational

To provide new ideas for the treatment of patients with ischemic heart failure, this study is to search for differential metabolic markers associated with ischemic heart failure and to study the influence of fecal flora on the course of heart failure in patients with ischemic heart failure.