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Heart Failure clinical trials

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NCT ID: NCT06422832 Not yet recruiting - Heart Failure Clinical Trials

Remote Monitoring To Identify Worsening Heart Failure The REMOTI-HF Randomized Clinical Trial

REMOTI-HF
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Heart failure, characterized by high mortality and morbidity rates, frequent hospital admissions, and prolonged stays in cardiology wards, significantly impacts patients' quality of life. The REMOTI-HF is a single-center randomized controlled trial designed to assess the impact of remote monitoring, utilizing the HeartLogic and TriageHF algorithms, in patients with heart failure with implantable cardioverter defibrillator or cardiac resynchronization therapy. The primary endpoints include mortality, hospital admissions related to heart failure, and visits for worsening heart failure. Moreover, we will explore the full capabilities of these algorithms, by analysing the association of physical activity, measured by the devices, with the same key outcomes. Additionally, the research will explore the relationship between the absolute values provided by the algorithms and NT-proBNP values.

NCT ID: NCT06418932 Recruiting - Heart Failure Clinical Trials

Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure

Start date: May 20, 2024
Phase: N/A
Study type: Interventional

Randomized 1:1 multicenter double-blind clinical investigation evaluating the efficacy and safety of compression therapy of the lower limbs plus parenteral administration of diuretics vs. administration of parenteral diuretics alone (standard treatment) in patients with decompensated HF and predominantly systemic tissue congestion and absence of intravascular systemic congestion. Patients will be assigned to standard treatment (parenteral administration of furosemide) versus parenteral administration of furosemide plus lower limb compression therapy for up to 72 hours. The dose of furosemide in all participants will be based on the clinical judgment of the responsible healthcare professional.

NCT ID: NCT06417242 Not yet recruiting - Heart Failure Clinical Trials

Predicting Outcomes in Atrial Fibrillation and Heart Failure

PrOAF-HF
Start date: May 2024
Phase:
Study type: Observational

PrOAF-HF will aim to test if rhythm control delivered through catheter ablation in patients in whom it is not clear whether atrial fibrillation or heart failure were the first disease results in a greater improvement in left ventricular ejection fraction (LVEF) compared with patients where heart failure was diagnosed first with no evidence of AF.

NCT ID: NCT06414928 Recruiting - Heart Failure Acute Clinical Trials

Prognostic Model Heart Failure

Start date: February 14, 2024
Phase:
Study type: Observational [Patient Registry]

This study aims to determine the prognosis of heart failure in our population by using multiple validated risk scores and to evaluate the strengths of these scores in assessing prognosis with better discrimination.

NCT ID: NCT06414759 Not yet recruiting - Edema Clinical Trials

Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload

Start date: May 22, 2024
Phase: Phase 4
Study type: Interventional

This study aims to compare two medications, acetazolamide and metolazone, along with loop diuretics, to see which one works better and is safer for patients with ADHF who have volume overload. By comparing these medications, we hope to learn which one can help these patients the most. This will help doctors choose the best treatment for patients with ADHF and volume overload.

NCT ID: NCT06414265 Recruiting - Heart Failure Clinical Trials

Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation

CASSINI-EU
Start date: April 4, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter approach. The main questions it aims to answer are: - is the use of the device feasible? - is it safe (defined as freedom from device-related major adverse events at 30 days)? - does it perform (defined as reduction of MR Grade to ≤ 1+ at 30 days)? Participants will need to do the following as part of the clinical trial: - complete 6-Minute Walking Test - complete Quality of Life Questionnaires - undergo blood evaluations - CT scan - 12 lead ECG - Transesophageal Echocardiography - Transthoracic Echocardiogram - the study procedure (valve implantation, right heart catheterization, left arterial pressure, fluoroscopy/ angiogram)

NCT ID: NCT06411340 Not yet recruiting - Heart Failure Clinical Trials

Inflammation in Acute Cardiovascular Diseases - the CArdiovascular Inflammation Registry (CAIR)

CAIR
Start date: July 2024
Phase:
Study type: Observational [Patient Registry]

Following acute cardiovascular injury, inflammation is vital to activate reparative mechanisms. However, there is compelling evidence implicating excessive inflammation and dysregulated resolution in fibrosis, ventricular remodelling, and heart failure (HF). Recently, the anti-inflammatory agent colchicine reduced cardiovascular events after myocardial infarction (MI) compared to placebo, indicating that targeting inflammation in acute cardiovascular conditions is feasible. Several acute cardiovascular conditions are characterised by inflammation, including myocarditis, MI, and acute heart failure. However, there is large variability in definition, epidemiology, clinical presentation, pathophysiology, and natural history of acute inflammatory cardiovascular diseases. This relates, in part, to the difficulty in performing adequately powered studies. Clinical studies that include sufficient patients and extended observation periods are necessary to address some of these knowledge gaps. This registry aims to collate routinely collected clinical data on patients with acute cardiovascular diseases characterised by inflammation in an observational-based registry. By doing so, the investigators hope to understand the contribution of inflammation to the pathophysiology of acute cardiovascular disease, improve risk stratification, and identify potential novel therapeutic targets.

NCT ID: NCT06407154 Recruiting - Stroke Clinical Trials

Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures: an Observational Study, 2nd Wave

CLIMATE-II
Start date: May 21, 2024
Phase:
Study type: Observational

The CLIMATE-II Observational Study examines to what extent chronically ill patients experience adverse health effects because of heat and whether the patients' specific health behavior, somatosensory amplification, risk and benefit perception, self-efficacy, health literacy, degree of urbanisation of the patients' administration district and characteristics of the patients' neighborhood are associated with these effects.

NCT ID: NCT06405555 Not yet recruiting - Hypotension Clinical Trials

Midodrine in Heart Failure With Reduced Ejection Fraction With Hypotension

MIDOH-HF-P
Start date: August 1, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The evidence-based pharmacologic treatments available for patients with heart failure with reduced ejection fraction (HFrEF) has been established over the last few decades of cardiovascular research. These treatments, termed Foundational Guideline-Directed-Medical Therapies (GDMT), prolong patient life, improve patient-reported symptoms, and reduce hospitalizations for heart failure. A direct effect of most medication classes encompassed within GDMT is the reduction in blood pressure due to their mechanisms of action. In addition, as patients with HFrEF become more advanced in their disease, a significant proportion develop hypotension related to pump failure and autonomic dysfunction, amongst other possible mechanisms. As a result, a significant proportion of HFrEF patients are not optimized on GDMT with hypotension as their limiting barrier that would otherwise have served to improve their heart function, heart failure symptoms, and mortality. Currently, there does not exist any evidence-based strategies to address the problem of hypotension in HFrEF patients who are not optimized on GDMT. Midodrine is an alpha-adrenergic agonist (α1-AR) that exerts its effects on peripheral venous and arteriolar vasculature to increase blood pressure. This medication has been used off-label by some clinicians in the hypotensive HFrEF population to increase blood pressure and has been reported to have beneficial effects in improving GDMT utilization as well as increasing left ventricular ejection fraction (LVEF) in published case reports/case series. There does not exist any randomized prospective data on the use of midodrine in the hypotensive HFrEF population. The investigators' objective is to complete the first open-label, randomized control trial of midodrine in the hypotensive HFrEF population to demonstrate feasibility in performing a trial in this patient population and to show efficacy in increasing blood pressure without associated harm. The results of this trial will be used as the foundation and rationale for future studies assessing the impact of midodrine use on GDMT utilization as well as hard cardiovascular outcomes in the hypotensive HFrEF population, including hospitalizations for heart failure and mortality.

NCT ID: NCT06404021 Active, not recruiting - Heart Failure Clinical Trials

Electronic Device Implantation Through Remote Guidance

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) implants are limited by availability and costs of field clinical specialist (FCS) bioengineers. This study explores feasibility of remotely supported implantations through an internet based platform, aiming at enhancing efficiency and overcoming geographical or pandemic related barriers. The first phase of the study included programming and phantom assessments in 20 cases followed by 10 remote guided CRT-D and ICD implantations in additional heart failure patients, compared to 20 procedures with FCS on site. Data analysis revealed no significant differences in acute outcomes or electronic parameters at one year follow-up compared to on-site FCS. Finally, this study demonstrates the safety after testing at one year of follow-up.