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Heart Failure clinical trials

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NCT ID: NCT03387488 Not yet recruiting - Heart Failure Clinical Trials

Video Assisted Pericardioscopic Surgery: Minimal-invasive Implantation of Epimyocardial Pacemaker Leads in Humans

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

Particularly in CRT (Cardiac Resynchronisation Therapy), limited accessibility of the coronary sinus along with its branches and the mismatch between the region of latest left ventricular (LV) contraction and an adequate epimyocardial vein frequently lead to therapy failure and might even be responsible for the 30 % non-responders, although this aspect has not been thoroughly investigated yet. Further complications such as postoperative micro- (i.e. increased thresholds) or macro-dislodgement (i.e. loss of stimulation success) of the LV electrodes are frequent complications leading to reoperation or a change of strategy. The current transthoracic epimyocardial approach via mini-thoracotomy circumvents the aforesaid obstacles and is regarded as the first-choice alternative approach. Participation in the trial would prevent patients from this invasive, transthoracic approach and at the same time allow the same degree of freedom in lead placement. Risks and complications are in this case comparable to the open surgical approach but with a lower risk of intraoperative rib fracture, postoperative pain with consecutive pulmonary hypo-ventilation and pneumonia. Apart from the benefit of the single individual, societies benefit will include a much higher responder rate in CRT patients and less lead-associated infections. Thoracotomy with breach of the pleural cavity and single lung ventilation - a procedure that itself bears a high risk for postoperative atelectasis, pleural effusion and infection will be avoided. In patients on hemo-dialysis and patients who suffer from an infected pacemaker-system, extravascular lead placement should be preferred. Again, the current open, transthoracic epimyocardial approach via mini-thoracotomy is regarded as the first-choice alternative approach. Aim of this study is the validation of the feasibility of an alternative, minimal-invasive therapy method for implanting a cardiac pacemaker.

NCT ID: NCT03359967 Not yet recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Changes in Intrathoracic Impedance During Sacubitril/Valsartan Treatment

CHILISALT
Start date: February 12, 2018
Phase: N/A
Study type: Observational

The CHILISALT Study aimed to explore the effect of angiotensin-neprilysin inhibition on intrathoracic impedance and -derived fluid index in HFrEF patients who had a device for cardiac resynchronization therapy and/or an implantable cardioverter-deļ¬brillator (ICD; Medtronic Inc., Minneapolis, MN) allowing continuous measurement of intrathoracic impedance.

NCT ID: NCT03344523 Not yet recruiting - Clinical trials for Chronic Heart Failure

Evaluating Iron Protein Succinylate Oral Solution in Treating Chronic Heart Failure and Iron Deficiency

Start date: January 2018
Phase: Phase 4
Study type: Interventional

This study aims to evaluate the effect of standard heart failure therapy plus oral solution with protein succinylate iron compared to placebo on the primary end point of 6 minute walk distance at 24th week in patients with chronic ejection fraction reduction heart failure and iron deficiency.

NCT ID: NCT03341208 Not yet recruiting - Pulmonary Embolism Clinical Trials

Quantitative Assessment of RV Strain Using cMRI Following Catheter Intervention on PE

RVEF
Start date: December 1, 2017
Phase: N/A
Study type: Observational

Acute pulmonary embolism (PE) is a condition in which the vessels carrying blood to the lungs become suddenly blocked, usually by a blood clot. There are a number of adverse consequences that result, with one of the most significant being strain on the right side of the heart (which must push blood through the blocked arteries to the lungs). Although this strain on the right heart is very important, current methods for measuring it are flawed. The standard practice is to obtain an echocardiogram (ultrasound of the heart), from which indirect measurements of the size of the heart are used to make inferences about right heart strain. This method can help guide management in some patients, but it in not a sensitive test and does not provide detailed information. Patients with PE are treated with blood thinning medications. Some patients may be referred to the Interventional Radiology (IR) team for endovascular intervention, in which catheters are placed into the patient's vessels under radiologic guidance and advanced to the lungs to remove the clot entirely. Cardiac magnetic resonance imaging (MRI) is a well-established imaging technique that produces highly detailed images of the heart's structure and function, with no risks to patients of ionizing radiation or intravenous contrast. Cardiac MRI is far superior to echocardiogram in evaluation of the right side of the heart, however it has not been widely used in the evaluation of patients with PE. We propose that by using a fast MRI protocol, we will be able to detect right heart strain with more accuracy than echocardiogram. Furthermore, we hypothesize that MRI images obtained before and after IR catheter-directed therapy will demonstrate the degree to which strain is relieved with this treatment. Finally, we believe that using MRI may help to guide management of patients with PE by detecting early or mild heart strain before it progresses. In order to test these hypotheses, we plan to image PE patients who have been referred to the IR team with MRI. Patients recruited for this study will undergo two short MRI scans - one immediately before treatment, and one after completion of IR treatment (which lasts approximately 12-24 hours).

NCT ID: NCT03332888 Not yet recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Safety of HMA-CD20 in Patients With HFrEF

ICFEr-RITU2
Start date: January 1, 2021
Phase: Phase 2
Study type: Interventional

The study is a phase II single-centered, single group, prospective clinical trial to evaluate the safety of HMA-CD20 doses among stable patients with class III/IV according to the NYHA classification with HFrEF receiving standard of care therapy. The index qualifying HFrEF must have EF < 40% based on echocardiographic or cardiac MRI techniques, heart failure class III/IV according to the NYHA classification,aged 40-60 years, being diagnosed less than 12 months before enrollment of study, following the standard heart failure treatment regimen.

NCT ID: NCT03271879 Not yet recruiting - Heart Failure Clinical Trials

Empagliflozin Versus Placebo on the Rate of Arrhythmic Events in Heart Failure Patients

ERA-HF
Start date: February 15, 2018
Phase: Phase 4
Study type: Interventional

Empagliflozin treatment in high cardiovascular risk patients has been shown to have a relatively rapid powerful capability in reducing cardiovascular mortality. Among the suggested mechanisms mediating this effect of empagliflozin, anti-arrhythmic effect (AAE) has the highest potential to translate into a rapid clinical beneficial effect on cardiovascular mortality, while other mechanisms are known to have a lag in their clinical effect based on data from previous studies. Based on this assumption, the study driving hypothesis is that the effect of empagliflozin on the rate of cardiovascular death may be mediated by a direct effect on the risk for arrhythmic events (via a direct or an indirect effect on the myocardium). The current study aims at assessing the effect of empagliflozin on arrhythmias in diabetic patients with HF with reduced ejection fraction and relatively high arrhythmic burden. The objective of the current study is to demonstrate the effect of empagliflozin compared to placebo on the rate of ventricular arrhythmic events in type 2 diabetes patients with heart failure with reduced ejection fraction and high risk arrhythmic profile.

NCT ID: NCT03227198 Not yet recruiting - Heart Failure Clinical Trials

IMMNC-HF: IntraMyocardial Injection of Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients

IMMNC-HF
Start date: October 14, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess the Evaluation of the intramyocardial injection of autologous bone marrow derived mononuclear stem cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(<=30%) when compared to a control group of patients undergoing best medical care.

NCT ID: NCT03213821 Not yet recruiting - Renal Insufficiency Clinical Trials

Safety and Efficacy of High Protein Diet Versus GFR Based Protein Diet in Heart Failure Patients With Renal Insufficiency

GFR
Start date: November 1, 2017
Phase: N/A
Study type: Interventional

Effect of high calorie high protein diet versus high calorie,glomerular filtration rate (GFR) based protein intake in non-obese advanced HF patients will be assessed. In this regard, protein intake impact will be measured on muscle mass, physical performance and renal function as main outcome. Rehospitalization, quality of life, depression an inflammatory status are second endpoints.

NCT ID: NCT03145402 Not yet recruiting - Heart Failure Clinical Trials

ICMNC-HF. IntraCoronary Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients

ICMNC-HF
Start date: October 20, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess that a single intracoronary infusion of autologous bone marrow-mononuclear cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(<=30%) when compared to a control group of patients undergoing best medical care.

NCT ID: NCT03083717 Not yet recruiting - Heart Failure Clinical Trials

Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples

Start date: April 20, 2017
Phase: N/A
Study type: Observational

Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples. Breath testing, which links specific volatile molecular biomarkers in exhaled breath to medical conditions, is becoming increasingly popular as a non-invasive and potentially inexpensive diagnostic method for various diseases. NA-NOSE performs odor detection from exhaled breath, thus producing a distinct fingerprint for each mixture of analytes. Several studies have been published, stating the advantages of these sensors, leading to promising outcomes in several fields. The NA-NOSE breath test would be fast (examination and results would be obtained within 5-10 min), inexpensive, eventually portable (smaller than desktop computer), non-invasive and free of any side effects.