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Heart Failure clinical trials

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NCT ID: NCT04539093 Completed - Clinical trials for Endothelial Dysfunction

Endothelial Function in Mechanical Circulatory Support

Start date: January 1, 2022
Phase:
Study type: Observational

The pathophysiology of HF is highly variable, with overlapping pathogenic mechanisms that complicates any attempt to create a simple and unified conceptual model. Left ventricular (LV) ejection fraction (EF), assessed as the fraction of the end-diastolic volume that is ejected upon contraction, has been the cornerstone metric for characterization of LV systolic function in patients with HF. LVEF demonstrates a strong inverse relationship with clinical outcomes in HF in patients with reduced EF (HFrEF). Current management options for the treatment of HFrEF include medical management, mechanical circulatory support, and cardiac transplantation. In the setting of refractory end stage HFrEF, the standard of care is heart transplantation. Since limited organ procurement is a significant constraint to the treatment of patients with advanced disease, durable mechanical circulatory support (MCS) with left ventricular assist devices (LVAD) were developed as a safe and efficacious treatment strategy for patients with advanced HF that is refractory to medical therapy. The advances in LVAD engineering and design, tailored towards defined physiological goals, have resulted in the creation of much smaller continuous-flow (CF) pumps that possess technical superiority, pump durability, and ease of implantation compared to the older and larger pulsatile-flow pumps. The addition of speed modulation algorithms to the next generation centrifugal CF LVADs, has decreased the incidence of device related adverse events. Our interest lies in the impact of continuous flow hemodynamics on endothelial function and the cardiac and end-organ responses to this novel therapy. Current knowledge of the impact of these specific advances in LVAD therapy is however limited by the relative youth of the field. Thus, the goal of this research project is to study human LVAD patients and to determine the impact of speed modulation algorithms in CF physiology on microvascular and endothelial function and its association with cardiac and peripheral organ function. The investigators hypothesize that restoration of cardiac output using an LVAD with modern speed modulation algorithm improves vascular endothelial function. In addition, these changes would have a positive correlation with functional outcomes.

NCT ID: NCT04533997 Completed - Heart Failure Clinical Trials

Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

Start date: January 1, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare intravenous furosemide (125 to 250 mg), isolated or in combination with hypertonic saline solution (2.6% to 3.4%) in the outpatient heart failure patient. The hypothesis is that the combination therapy will increase the diuresis volume at 3 hours and improve congestion parameters at 7 days.

NCT ID: NCT04531280 Completed - Asthma Clinical Trials

Rural Home Hospital: Proof of Concept

Start date: February 18, 2021
Phase: N/A
Study type: Interventional

This study examines the implications of providing hospital-level care in rural homes.

NCT ID: NCT04526535 Completed - Heart Failure Clinical Trials

Prognostic Value of Lung Ultrasound in ST Segment Elevation Acute Myocardial Infarction (LUS-AMI)

LUS-AMI
Start date: June 15, 2020
Phase:
Study type: Observational

The purpose of this study is to asses the prognostic value of lung ultrasound in patients with ST-segment elevation acute myocardial infarction.

NCT ID: NCT04515290 Completed - Clinical trials for Chronic Heart Failure

A Phase IIa Clinical Trial on TSG-01 in the Treatment of Chronic Heart Failure in Patients With Coronary Heart Disease.

Start date: May 7, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, efficacy and optimal dose of TSG-01, an innovative drug with ginsenosides as its main components, in the treatment of patients with chronic heart failure(CHF). Preclinical studies have revealed that TSG-01 promote myocardial energy metabolism and ATP production, reduce the damage of human pulmonary microvascular endothelial cell connection, resist arrhythmia, and regulate the lipid metabolism disorder caused by myocardial ischemia. Results from CHF animal models(dog, rat) showed that TSG-01 significantly increase coronary blood supply, improve myocardial contractility, reduce heart expansion and pulmonary edema. Besides its potency of improving heart function, TSG-01 was found to induce diuresis without obvious effect on urine potassium in rats. TSG-01 has been approved by CFDA for a clinical trial on the treatment of CHF (Approval No. 2018L03012). A randomized, double-blind, multicenter, placebo-controlled phase IIa clinical trial is now being conducted in 5 hospitals in China. A total of 90 cases of CHF caused by coronary heart disease are included and randomly divided into three groups: high-dose, low-dose of TSG-01 and placebo group. NYHA functional class, 6-minute walk test(6MHWT) distance, NT-proBNP, left ventricular ejection fraction(LVEF), echocardiographic parameters (LVESV, LVEDV, and heart size) and MLHFQ score are measured before, during and after treatment to evaluate the benefits of TSG-01 therapy in patients with CHF.

NCT ID: NCT04514458 Completed - Clinical trials for Heart Failure With Reduced Ejection Fraction

Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure

PROMPT-HF
Start date: January 25, 2021
Phase: N/A
Study type: Interventional

A randomized controlled trial to compare the efficacy of an electronic health record-based alert informing providers about evidence-based medications for HFrEF versus usual care (no alert) in outpatient clinics across a single health system.

NCT ID: NCT04512703 Completed - Heart Arrhythmia Clinical Trials

Feasibility Study of the µCor Heart Failure and Arrhythmia Management System (PATCH)

PATCH
Start date: October 25, 2018
Phase:
Study type: Observational [Patient Registry]

Prospective, non-interventional, feasibility study. 8 months, from start of screening to finishing the study. Multi-center study, with a maximum of 8 centers in Europe. Health adult volunteers (21 years or older) and adult patients with a clinical indication for ambulatory outpatient cardiac monitoring. To observe the feasibility of remotely monitoring patients with the novel µCor Heart Failure and Arrhythmia Management System (µCor system ) that non-invasively captures thoracic fluid content, electrocardiogram, heart rate, respiratory rate, activity, and body posture. tory outpatient cardiac monitoring.

NCT ID: NCT04510779 Completed - Heart Failure Clinical Trials

Apple Watch Heart Failure Study

Start date: May 9, 2022
Phase: N/A
Study type: Interventional

This is a pilot/feasibility study on the accuracy of HRV as measured by the Apple Watch on heart failure patients who are admitted to the hospital with heart failure exacerbation. The primary aim is to observe a statistically significant improvement in the HRV of acutely decompensated heart failure patients upon discharge when compared to admission, implying the utility of HRV measured by Apple Watch as a monitor for cardiovascular health.

NCT ID: NCT04509674 Completed - Clinical trials for Myocardial Infarction

EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction)

Start date: December 16, 2020
Phase: Phase 3
Study type: Interventional

This is a study in adults who had a heart attack (myocardial infarction). The purpose of this study is to find out whether a medicine called empagliflozin helps to lower the chances of having to go to the hospital for heart failure and whether it lowers the chances of dying from cardiovascular disease. People who are in hospital may join the study soon after being treated for their heart attack. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. All participants continue their standard treatment. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. Empagliflozin is a medicine that helps people with type 2 diabetes to lower their blood sugar. Researchers think that empagliflozin might also help people after heart attack who are at risk for heart failure, whether or not they have diabetes. Participants are in the study for about 1 to 2 years. During this time, there are about 4 visits inperson, 2 visits are done either by phone or by use of an mobile application. Results between the empagliflozin and placebo groups are compared. The doctors also regularly check the general health of the participants.

NCT ID: NCT04509089 Completed - Clinical trials for Congestive Heart Failure

Establishing Correlation Between Non-invasive Pulmonary Blood Pressure Readings and Swan-Ganz Results

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Pulmonary hypertension (PH) is prognostic indicator in heart failure patients for poor outcome, however, it is challenging for monitoring. The current study is designed to explore whether data generated using Suremedix Device including a pump and non-invasive sensors including, chest motion sensor, photoplethysmography (PPG), and Electrocardiography (ECG), can be used to identify detectable oscillations that are correlated with the mean, the diastolic and the systolic pressure values of the pulmonary artery, as measured using the gold-standard Swan-Ganz method.