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Decompensated Heart Failure clinical trials

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NCT ID: NCT06397833 Not yet recruiting - Heart Failure Clinical Trials

A Prospective, Observational, Single Centre Study to Assess the Feasibility of the Data Harvested by the Acorai Intracardiac Pressure Monitoring (ICPM) System in Predicting Prognosis in Patients Discharged From Hospital After Treatment for Acute Decompensated Heart Failure

Start date: April 29, 2024
Phase:
Study type: Observational [Patient Registry]

Acorai is developing the Acorai Heart Monitor, a handheld electronic device for monitoring pressures inside the heart in a non-invasive manner, by placing the device on the chest of a patient. Currently these intracardiac pressures are measured in an invasive way, during a right heart catheterisation procedure. This procedure carries risks to the patient. There is a clinical need for a non -invasive, easy to use, tool to monitor patients that suffer from heart failure. The study aim is to use the Acorai device to collect the intracardiac pressure measurements from patients admitted to hospital with heart failure and who are awaiting discharge home. Using the data, we will assess the feasibility of the Acorai derived cardiac output measurements, and assess what data best predicts survival, death, or major adverse cardiac events (MACE)

NCT ID: NCT06286423 Recruiting - Heart Failure Clinical Trials

Colchicine in Acutely Decompensated HFREF

Start date: June 2024
Phase: Phase 4
Study type: Interventional

This is a double blind, placebo-controlled pilot trial randomizing patients admitted to the hospital with acutely decompensated heart failure (ADHF) and inflammation to receive either colchicine or matching placebo. Upon enrollment, patients will be randomized 1:1 to receive either the experimental drug (Colchicine) or matching placebo. The regimen in the active arm will consist of 14 days of Colchicine 0.6 mg bid followed by 76±14 days of Colchicine 0.6 mg once per day. Placebo regimen will be analogous, with one pill bid for 14 days followed by one pill once per day for 76 days. Dose reduction for patients with Stage III chronic kidney disease is allowed as detailed in the protocol. At the same time, dose reduction can also be elected in case of GI symptoms. The study team will transiently stop the experimental medication in case of acute kidney injury (AKI), defined per Kidney Disease Improving Global Outcomes (KDIGO) Stage I, as specified in the protocol. These patients will continue with their standard of care for the management of heart failure which consists of a combination of medications that relieve congestion, normalize blood pressure and heart rate, and block the effects of hormones on the heart. The proposed treatment will be in addition to standard of care. No standard of care medications will be withheld. While inflammation is a known risk factor in heart failure, there are no standard anti-inflammatory drugs used in patients with heart failure, as the benefit is not established. The study team will study colchicine, an anti-inflammatory drug, as compares with placebo. Blood will be obtained from the patients in order to measure hsCRP and IL-6. Blood samples will be collected at baseline, 24±6h, 48±6h and 72±6h after treatment initiation, and subsequently at 14±7 days and at study closure. The first four blood samples will be obtained while the subject is still admitted to the hospital. The blood sample at 14±7 days will be obtained during an outpatient encounter. A study closure visit with clinical assessment and experimental drug collection for capsule counting to assess compliance will be conducted at 90±14; the final blood sample will be collected at that time.

NCT ID: NCT06273397 Not yet recruiting - Clinical trials for Decompensated Heart Failure

Acetazolamide or Metolazone in Acute Heart Failure

ACME-AHF
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Impact of Acute Heart Failure: According to the World Health Organization (WHO), approximately 26 million people suffer from Heart Failure (HF), with a mortality rate of up to 50% within five years of diagnosis. Acute Heart Failure (AHF) exacerbations, leading to hospitalization, are common and represent the primary cause of hospital admissions in those over 65. Effective decongestion during hospitalization is crucial, as failure to achieve it doubles the risk of rehospitalization and mortality, incurring significant healthcare costs. Use of Diuretics in Acute Heart Failure: Diuretics, particularly loop diuretics like furosemide, are a cornerstone in managing AHF by inducing natriuresis and achieving decongestion. Clinical experience supports their use, though limited clinical trials exist. Pharmacological concepts guide their administration, emphasizing intravenous delivery in high doses and adjusting subsequent doses based on decongestive efficacy. Additionally, sequential tubular blockade with other diuretics like metolazone and acetazolamide is explored to enhance decongestion. Use of Metolazone and Acetazolamide: Sequential tubular blockade, using metolazone and acetazolamide in conjunction with furosemide, aims to achieve rapid and effective decongestion. While metolazone targets the distal tubule, inhibiting sodium-chloride channels, acetazolamide affects proximal tubular function. Studies like ADVOR (acetazolamide) and CLOROTIC (thiazide-like diuretic) demonstrate the potential benefits of combining these diuretics for quicker decongestion but with potential risks (in the case of Hydrochlorothiazide). Outcomes Measured by Major Studies: Recent studies assessing decongestion in AHF reveal a lack of uniformity in outcome selection. The primary focus should be on reducing rehospitalizations and post-discharge mortality by achieving effective decongestion. The ADVOR study, using a simple congestion score based on clinical and imaging criteria, underscores the importance of reaching a congestion score of 0 or 1 promptly. Congestion Monitoring: Monitoring diuretic treatment solely based on clinical aspects may not capture subclinical congestion, necessitating biochemical and imaging parameters. The ACME-AHF trial proposes a diagnostic score integrating clinical and imaging aspects to evaluate congestion status. Secondary outcomes include cumulative diuresis, weight loss, diuretic efficiency, and natriuresis, with a focus on natriuresis as a reliable physiological parameter for decongestion. Aim of the study: The ACME-AHF trial is designed to compare the efficacy and safety of two diuretic combination strategies: acetazolamide with furosemide and metolazone with furosemide. The primary objective is to relieve congestion, assessed using a congestion score, within the first three days of treatment during an hospitalization for acute heart failure.

NCT ID: NCT06114498 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Hospital Register of Decompensated Heart Failure With Preserved Ejection Fraction

Start date: September 1, 2023
Phase:
Study type: Observational [Patient Registry]

Study Aim is creation of the Hospital Register of patients with heart failure with preserved ejection fraction (HFpEF) for a comprehensive assessment of the influence of gender characteristics, clinical and anamnestic factors, body composition, topical characteristics of congestion, instrumental data and markers of cellular inflammation and stress on immediate and long-term outcomes in patients with acute decompensated heart failure with preserved ejection fraction. During the study it is planned to assess gender, clinical and anamnestic indicators preceding hospitalization of patients in the hospital; characterize the features of comorbid status in the studied group of patient; study the features of drug therapy at the prehospital stage and during hospitalization in the study group of patient; assess adverse hospital outcomes and outcomes 6 months after hospital discharge and identify factors associated with them; assess body composition in patients with acute decompensated heart failure with preserved ejection fraction in obese patients upon admission to the hospital; characterize the severity and topical characteristics of congestion and compare with the phenotypes of acute decompensation of heart failure; asess adverse in-hospital outcomes and outcomes 6 months after hospital discharge and identify factors associated with them; conduct a clinical and instrumental examination of patients diagnosed with compensated and decompensated HFpEF, verified by echocardiography at rest, as well as in patients with HFpEF verified after an additional diastolic stress test with assessment of intracardiac hemodynamic; analyze the serum concentrations of biochemical markers associated with cellular stress in these groups of patients, as well as in the control group of apparently healthy people; conduct an analysis of associations of biomarker levels with clinical characteristics of patients, the presence of comorbid diseases, including obesity, as well as with data from instrumental examination methods; assess the diagnostic capabilities of HFpEF, defined by various criteria, based on the concentration of the new biomarkers The results obtained will allow us to evaluate the characteristics of the course and outcomes of the disease in Moscow patients, depending on the phenotype of acute decompensation of HFpEF, hospitalized in the hospital during the study period. It is expected to identify phenotypes of acute decompensation of HFpEF that affect the duration of hospitalization and the development of adverse outcomes in the hospital and long-term period of the disease.

NCT ID: NCT05927285 Completed - Acute Kidney Injury Clinical Trials

Effect on Kidney Function Recovery Guiding Decongestion With VExUS in Patients With Cardiorenal Syndrome 1

Start date: March 20, 2022
Phase: N/A
Study type: Interventional

During cardiorenal syndrome type 1 (CRS1) vascular congestion is the major contributor to worsening renal function, but promoting decongestion with routine clinical evaluation is ineffective in some patients. The venous evaluation by ultrasound (VExUS) may optimize its management when evaluating for improvement in kidney function and other metrics related to decongestion.

NCT ID: NCT05910437 Not yet recruiting - Clinical trials for Decompensated Heart Failure

Optimizing Treatments for Heart Failure During Hospitalization

OPTICARD
Start date: September 2023
Phase:
Study type: Observational

Heart failure reaches 1.5 million people in France and is responsible for 200,000 hospitalizations per year. Over the past ten years, new therapies have emerged (treatment of martial deficiency, Entresto, iSGLT2). Hospitalization in a context of acute heart failure is a moment of choice in the history of the disease to introduce recommended treatments under closer supervision (clinical, biological) than in ambulatory, and allows a decrease in hospitalizations, morbidity and mortality. The purpose of this study is to describe the introduction of heart failure drugs (including iSGLT2) in real-life settings in patients hospitalized for decompensated heart failure.

NCT ID: NCT05596292 Recruiting - Clinical trials for Decompensated Heart Failure

Sensation of Dyspnea and Experience of Patients With Heart Failure

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

This randomized clinical trial aims to evaluate patients with decompensated heart failure undergoing an early mobilization protocol with the use of immersive virtual reality glasses compared with patients undergoing the same protocol but without immersive virtual reality. The primary outcome will be the sensation of difficulty breathing, and the secondary outcome will be whether this technology provided a positive experience for patients in the intervention group that was superior to that of patients in the control group.

NCT ID: NCT05090930 Recruiting - Sepsis Clinical Trials

Innovative Technologies for the Treatment of Pulmonary and Heart Failure

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

The purpose of the program. Formulation of new treatments for heart and pulmonary failure through using organ-replacing technologies. Formulation of a clinical protocol and implementation of treatment methods into clinical practice heart and pulmonary failure using organ-replacing technologies. New methods were created for rehabilitating the function of affected organs after implantation of the LVAD, a total artificial heart, an extracorporeal life-sustaining system will be of great importance, both for Kazakhstan and for states with similar problems of donor organ deficiency, will also improve the effectiveness of surgical treatment and reduce the level of complications and mortality of patients on the extracorporeal life-sustaining system and septic patients.

NCT ID: NCT04901039 Terminated - Heart Failure Clinical Trials

Strategies for Assessment of Fluid Overload in Acute Decompensated Heart Failure

FLUID-AHF
Start date: April 14, 2022
Phase:
Study type: Observational

Heart failure (HF) is the endstage of all heart disease, characterized by inability of either the left or right heart or both to maintain sufficient output of blood for the demands of the body at normal filling pressures. Patients with HF are often admitted to hospital with decompensation and treated with diuretics. Residual congestion at discharge is associated with increased risk of early rehospitalization and adverse outcomes. However, determination of residual decompensation is complicated and a large number of patients admitted with decompensated heart failure are likely discharged before optimal decongestion has been achieved. Lung ultrasound (LUS) is a promising method to determine residual decompensation with the evaluation of B-lines. In this study our primary aim is to evaluate if LUS together with echocardiographic evaluation of filling pressure according to the European Society of Cardiology (ESC) algorithm performs better than clinical assessment to determine fluid status and risk of early rehospitalization in patients hospitalized for AHF.

NCT ID: NCT04740242 Completed - Heart Failure Clinical Trials

Metabolic Alkalosis in Heart Failure

Start date: January 1, 2021
Phase:
Study type: Observational

Metabolic alkalosis (MA) is the most common acid-base disorder and when it's severe it can have effects on cellular function and contribute to an increase in mortality. MA is a common complication of heart failure (HF) especially when patients are treated with diuretics, but few studies have analyzed the prevalence of acid-base disorders in patients with HF. All these studies have shown that MA is more common in patients with HF in more advanced stages and that the use of diuretics increases the prevalence of MA. The study hypothesis, based on clinical experience and the few data that exist in the scientific literature, is that MA is a frequent analytical disorder in patients admitted for decompensated HF and that its presence entails a worse short-term vital prognosis. The ALCALOTIC study is an observational cohort and prospective study. The main objectives of the study are the following: 1. To determine the prevalence of MA in patients admitted for decompensated HF 2. To analyze if there are differences in patients admitted for HF according to the presence of MA on admission 3. To determine if the presence of MA has an influence on the short-term prognosis in patients admitted for decompensated HF