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Heart Failure clinical trials

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NCT ID: NCT05355506 Suspended - Heart Failure Clinical Trials

The Development and Effectiveness of Heart Failure Self-Health Management Application

Start date: July 1, 2019
Study type: Observational [Patient Registry]

Aims: To develop a smartphone application and investigate its effectiveness on patients with heart failure after using the "heart failure self-health management application.".

NCT ID: NCT05353166 Suspended - Heart Failure Clinical Trials

Safety and Tolerability of Single Ascending Intravenous (IV) Doses of REGN5381 in Adult Heart Failure Patients With Elevated Pulmonary Capillary Wedge Pressure

Start date: June 30, 2022
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the safety and tolerability of single doses of REGN5381 in patients with heart failure with evidence of congestion The secondary objectives of the study are to: - Evaluate the effects of single doses of REGN5381 on hemodynamic parameters - Evaluate the effects of REGN5381 on a clinical biomarker of heart failure severity - Characterize the pharmacokinetics (PK) of single doses of REGN5381 - Assess the immunogenicity of REGN5381

NCT ID: NCT04851236 Suspended - Clinical trials for Advanced Heart Failure

Pilot Study of Massage Therapy to Improve Self Efficacy in Patients With Left-ventricular Device

Start date: July 1, 2019
Phase: Early Phase 1
Study type: Interventional

To collect and compare pilot data on the impact of a massage therapy intervention against usual care on self-efficacy measures for patients with advanced heart failure immediately discharged from hospital following left-ventricular assist device (LVAD) implantation.

NCT ID: NCT04701112 Suspended - Clinical trials for Heart Failure, Systolic

Acute Hemodynamic Effects of Pacing the His Bundle in Heart Failure

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

Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is indicated for patients with low ejection fraction and persistent symptoms of heart failure despite medical therapy and a wide QRS-complex, preferably with a left bundle branch block. Unfortunately, up to 40 % receiving CRT do not respond with subjective improvement or improved left ventricular ejection fraction from the treatment. There are few therapeutic alternatives in patients not responding to CRT with BVP, and the potential to improve cardiac function in these patients could make a large difference in terms of life quality and prognosis. His-bundle pacing (HBP) can be a suitable alternative, but is likely not possible in all patients with failed CRT. Furthermore, upgrading to HBP does require a surgical procedure and therefore exposes the patients to risk of complications (e.g. infection of the device). Therefore, early identification of the patients who are likely to benefit from an upgrade to HBP would be beneficial. This study aims to evaluate if patients with failed CRT treatment will benefit from hemodynamic improvement if they are treated with temporary HBP, without opening the device-pocket, and exposing the existing pacemaker-device to a risk of infection. A temporary pacemaker lead and pacing sheath will be used, and placed in the heart via a blood vessel on the right side of neck, using local anaesthesia. Acute effects on the pump function of the heart will be measured during rest and during supine bicycle test (the equivalent of moderate physical activity). Factors associated with a beneficial effect will be evaluated on a group basis. If the individual patient experiences an improvement of cardiac function during the test, he/she will be offered an upgrade to HBP and a replacement of the existing device.

NCT ID: NCT04589065 Suspended - Heart Failure Clinical Trials

SCD for CRS in Congestive Heart Failure (CHF) (No Left Ventricular Assist Device)

Start date: September 2024
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to see if a new device (SCD) is safe and if it can reduce damage to the kidney enough to allow medications to work to improve heart and kidney function for use in patients that have moderate to severe heart failure and is at least in part due to heart failure and it not responding to standard medical therapy. The SCD is a cartridge used with a commercial hemodialysis unit. Participants will be enrolled in the clinical trial once eligibility is confirmed. In addition to clinical assessments and laboratory testing participants will have surface echocardiograms during the trial. The SCD treatment will take place for 4 hours on day 1, 3, and 5 while on hemodialysis.

NCT ID: NCT04350541 Suspended - Heart Failure Clinical Trials

Effects of HIIT in Tolerance to Exercise of Individuals With HF and Coexisting COPD

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

INTRODUCTION: The complexity of the pathophysiology of heterogeneous diseases such as heart failure and obstructive pulmonary disease causes a different approach to these diseases or with a view as much as a better understanding of the same situations, with which the clinical profile of patients who are associated with an association is. It is known that regular physical training promotes progressive improvements in exercise tolerance, in the pulmonary ventilation / perfusion ratio and in respiratory function by strengthening. OBJECTIVE: To compare the effects of high-intensity interval training and continuous aerobic exercise, with peripheral endothelial function, brain natriuretic peptide levels, maximum exercise tolerance, distribution of lung volumes and quality of life of patients with obstructive pulmonary disease associated with heart failure. METHODS: This is a clinical, controlled, randomized and blinded trial. Peripheral endothelial function, tolerance to maximum and submaximal exercise, distribution of lung volumes, quality of life, presence of symptoms of depression and perception of clinical change will be evaluated. EXPECTED RESULTS: Incorporate into the care of these patients, new effective therapeutic approaches, of low cost and with greater technical and scientific evidence.

NCT ID: NCT04117295 Suspended - Clinical trials for End-stage Heart Failure

Carmat TAH Early Feasibility Study

Start date: July 12, 2021
Phase: N/A
Study type: Interventional

Feasibility study of the Carmat TAH as a treatment for transplant-eligible patients in severe, end-stage heart failure.

NCT ID: NCT03854071 Suspended - Clinical trials for Coronary Artery Disease

Development of Novel Physiological CMR Methods in Health and Disease

Start date: July 30, 2018
Phase: N/A
Study type: Interventional

Physiological cardiovascular stress test plays a crucial role in the assessment of patients with suspected heart disease. There are several methods of cardiac physiological stress tests and each of them offer varied insight into cardiac physiological adaptation: passive leg raise, intra-venous fluid challenge, pharmacological stressors and physical exercise stress test. Echocardiography, which is the mainstay for the non-invasive rest/stress assessment of the left ventricular (LV) haemodynamics has several limitations. Novel methods of CMR imaging allow to map intra-cardiac flow in three-dimension using novel flow acquisitions. These novel flow acquisitions are called four-dimensional flow CMR, where the fourth dimension is time. Additionally, traditional cine CMR imaging for functional assessment can now be done without breath-holds using advanced acceleration methods, allowing them to be used during exercise. A comprehensive understanding of functional-flow coupling at rest, during increased pre-load (fluid challenge) to the heart or during exercise, is lacking in the literature. There is an important need to validate these novel CMR methods for developing mechanistic insight into physiological cardiac adaptation to increased pre-load or to exercise in health and how it alters in heart disease.

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.