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Heart Failure clinical trials

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NCT ID: NCT05834400 Recruiting - Heart Failure Clinical Trials

Lymphatic System Stimulation in Heart Failure

Start date: June 15, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot clinical trial is to obtain preliminary data on the effects of lymphatic exercise training in patients with heart failure. The main question[s] it aims to answer are: 1. Does performing lymphatic exercise decrease fluid overload symptoms (shortness of breath, lower legs swelling, fatigue), thoracic fluid content, and body fluid level? 2. Does performing lymphatic exercise improve sleep and quality of life (QOL)? Participants with heart failure will be randomly assigned into two groups: Group 1 will receive training on lymphatic exercises, and will perform these training for 4 weeks. This group will also be trained to monitor daily their weight, heart rate and blood pressure, and fluid overload symptoms. Group 2 will be trained to daily monitor their weight, heart rate and blood pressure, and fluid overload symptoms. This group will not perform the lymphatic exercises. Researchers will compare the two groups at the baseline and after delivering the 4 week-interventions to see 1. if lymphatic exercise helped decrease symptoms associated with fluid overload like shortness of breath, lower leg swelling, and fatigue. 2. if lymphatic exercises decreased thoracic fluid content and total body fluid level . 3. if the lymphatic exercise helped improve sleep and quality of life (QOL).

NCT ID: NCT05833581 Recruiting - Heart Failure Clinical Trials

Consistently Assess Signs and Symptom of Heart Failure

CLASS-HF
Start date: March 17, 2023
Phase: N/A
Study type: Interventional

Heart failure (HF) is a major public health problem. The New York Heart Association (NYHA) Functional Classification by a HF provider helps to guide their decisions in patient treatment. The purpose of this study is to further examine the NYHA Classification Guide that is designed to assist healthcare providers. The investigators will conduct the study in the outpatient clinic setting where adult patients with chronic heart failure are treated. HF providers will be asked to complete the NYHA classification Guide and then participants will complete a standardized 6-minute walk test which is considered as the gold standard. Participant results will be compared between providers' assigned class and the results from the 6-minute walk test. The subsequent phase of the study will be incorporation of the NYHA Classification Guide into clinical practice. HF providers will use the NYHA Classification Guide for 30 days in the clinic setting and will report their perceptions.

NCT ID: NCT05830318 Recruiting - Asthma Clinical Trials

Usability and Acceptability Study of the P-STEP Mobile Application

Start date: August 23, 2023
Phase:
Study type: Observational

Assess the usability and acceptance of the P-STEP app, through allowing participants with specific chronic conditions to pilot the app for 12-weeks.

NCT ID: NCT05825755 Recruiting - Heart Failure Clinical Trials

Multicenter Trial for the Validation of HumanITcare Platform

VAL-HIC
Start date: March 20, 2024
Phase: N/A
Study type: Interventional

HumanITcare has implemented a cloud platform for the telemonitoring of chronic patients through portable medical devices and an alarm-based system that issues health alerts when a patient's biomedical measurement is outside a predefined clinical range. The platform frees doctors and caregivers from reviewing individual patient data for abnormalities, speeding up the decision-making process and reducing hospital visits. With this study we intend to validate the efficacy of the app for patients and digital platform for medical professionals, evaluating the increase in the quality of life of patients and measuring the reduction in the incidence of the main critical events of HF. In addition, the study will validate the new API interoperability standards and platform architecture and will assess the usability of the platform by delivering satisfaction questionnaires to patients and professionals at the end of the study. This study is being carried out within the framework of a European project promoted by the European Innovation Council (EIC).

NCT ID: NCT05825573 Recruiting - Heart Failure Clinical Trials

Anticoagulation Therapy in Non-device-related Intra-cardiac Thrombus

ARGONAUT
Start date: May 15, 2023
Phase: Phase 3
Study type: Interventional

Left ventricular thrombus is found in 10 to 25% of patients with impaired left ventricular function following ST-segment elevation myocardial infarction and up to 20% in dilated cardiomyopathy in observational studies. Likewise, the incidence of atrial thrombus among atrial fibrillation patients treated by vitamin K antagonist (VKA) is between 0.25% and 7%. Despite anticoagulant therapy, intra-cardiac thrombus remains a severe complication associated with a high risk of systemic embolism and subsequent mortality but also bleeding events related to the anticoagulation therapy. The class of non-vitamin K antagonist direct oral anticoagulant (DOA) has emerged in the last decades and has systematically surpassed VKA in the different clinical settings by providing at minimum a similar efficacy and a better safety profile. In the absence of randomized study in the specific clinical setting of intracardiac thrombus, international Guidelines recommend, on the basis of expert opinion, the use of VKA for at least 3 to 6 months in case of left ventricular thrombus and there is no specific recommendation for thrombus management from other cardiac localizations. In comparison to VKA, the easier management and the large evidence of better safety of DOA make it an interesting anticoagulant strategy. Data for left ventricule thrombosis treatment are limited and only supported by observational cohorts. However, these recent cohorts have shown promising data in this indication reporting similar thrombus regression following DOA in comparison to VKA and similar ischemic outcomes although no head-to-head comparison would be powered. As a consequence, the multicentric randomized ARGONAUT trial aims to confirm these results and evaluate the impact of DOA compared to VKA on thrombus regression and clinical outcomes among patients with intracardiac thrombus, regardless of the thrombus localization and any underlying heart disease.

NCT ID: NCT05824923 Recruiting - Hypertension Clinical Trials

A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure

PADN-HF-PH
Start date: August 14, 2023
Phase: Phase 3
Study type: Interventional

It's a phase III, prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation (PADN) for heart failure (HF) patients diagnosed with pulmonary hypertension associate with left heart disease (PH-LHD) by right heart catheterization.

NCT ID: NCT05817136 Recruiting - Heart Failure Clinical Trials

Prospective Longitudinal Evaluation of AI-ECG in a NEwly Diagnosed Heart Failure

(PLANE-HF)
Start date: January 11, 2023
Phase:
Study type: Observational

Background: Heart Failure (HF) is a condition in which the heart can no longer adequately pump blood around the body. The number of patients diagnosed with HF is increasing, consuming 4% of the NHS budget, and deadlier than most cancers. Most patients suffer from HF with reduced Ejection Fraction (HFrEF), where adequate treatment can improve quality of life and survival. Less than 50% of patients receive gold standard NHS guided medication and less than 20% receive appropriate monitoring (via echocardiography surveillance). This study looks at the use of a 'smart stethoscope' (Eko DUO), a stethoscope that uses information collected from the heart in the form of electrical (ECG) and sounds (phonocardiogram, PCG) waveforms, to predict the pumping function of the heart via artificial intelligence (AI-ECG). Aims: By using the smart stethoscope, this study evaluates whether the use of an easy-to-use home self-monitoring programme can: - Provide a solution for the current poor compliance of NHS echocardiogram surveillance programmes for people with newly diagnosed HF - Provide real-time assessment of heart function in response to medication changes - Improve the health economic and health outcomes of HF in the NHS Methods: 80 participants with newly diagnosed HFrEF, due to pre-existing heart disease and non-heart related causes, will be identified by the clinical team at Imperial College NHS Trust and obtain consent for the research team to approach them. All consented participants will receive a smart stethoscope and instructions for twice-weekly, 15-second self-examination for 3-months. Participants will also be invited for an additional echocardiogram at 6 weeks post-diagnosis, in addition to the routine, standard of care NHS echocardiogram surveillance for HF.

NCT ID: NCT05814263 Recruiting - Heart Failure Clinical Trials

HIS Alternative II - UK Site

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The study will investigate the feasibility of using direct HIS pacing or left bundle branch pacing (LBB pacing) as an alternative to biventricular pacing in patients with symptomatic heart failure and an ECG with a typical left bundle branch block pattern.

NCT ID: NCT05813652 Recruiting - Diabetes Mellitus Clinical Trials

Relative Impacts on Preventative Primary Care--a Longitudinal Evaluation of COVID-19:Phase 1

RIPPLE-C
Start date: October 5, 2022
Phase:
Study type: Observational

The goal of this observational study is to describe the impacts of COVID-19 on primary care chronic condition management in Canada within various patient populations. This will be done by analyzing primary care electronic medial record (EMR) data from the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) database, including data on primary care encounters, as well as various markers for chronic conditions. The research questions to be investigated are: 1a) What are the changes to the management of chronic conditions in primary care since the onset of the COVID-19 pandemic? 1b) How do these changes differ by age, health status, and socioeconomic status?

NCT ID: NCT05809011 Recruiting - Acute Heart Failure Clinical Trials

Efficacy and Safety of corticoSTEROids Added to Standard Therapy in Patients With Acute Heart Failure (STERO-AHF)

STERO-AHF
Start date: April 24, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

STERO-AHF is a pilot, prospective, multicenter, randomized, open-label, controlled study aimed to evaluate the diuretic efficacy and early clinical benefit of corticosteroid therapy administered for 7 days, in addition to standard therapy, in patients hospitalized for acute heart failure (AHF) and with evidence of insufficient diuretic response. Eligible patients will be randomized 1:1 to receive either standard-of-care alone (control group) or standard-of-care plus corticosteroid therapy (experimental group) for up to 7 days. Patients will be followed to 30 days.