Clinical Research Directory

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.

INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery

The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.

RHYthm and Myocardial Function Relationship Evaluation in Heart Diseases

Arrhythmias are widespread among the global population. Although they can occur in healthy hearts, they are often the manifestation of a hereditary or acquired heart muscle disease, and may be the cause or, more often than not, the consequence. In recent decades, with advances in medical knowledge and technology, non-pharmacological therapies for arrhythmias have become increasingly popular. These fall into two broad categories: therapies aimed at electrostimulation and those aimed at ablation of arrhythmias. The selection of patients eligible for these procedures is essential for the effectiveness of the therapy, the reduction of complications and the optimisation of resources. Not all patients, even those selected according to guidelines, respond equally to the chosen therapy. Other patients, due to their clinical/ECG characteristics, do not have clear indications and remain in a borderline area where the class of evidence and/or recommendation of the guidelines is less stringent. Still others develop recurrences or complications during follow-up that require further intervention. In this context, it is essential in the study of these patients not only to use standard instrumental examinations, such as echocardiograms, Holter ECGs and stress tests (simple and cardiopulmonary), but also and above all to use advanced imaging methods (STE, 3D echo, MRI, CT, PET-CT) and remote monitoring tools that integrate diagnostic algorithms managed by artificial intelligence. In light of these considerations, our project consists of conducting an observational study that includes all patients with arrhythmias who are candidates for electrostimulation and/or ablation procedures at the Arrhythmology Unit and/or followed up at the Arrhythmology Clinic of our Polyclinic, in order to assess the clinical and/or imaging characteristics associated with a worse prognosis in this population, in terms of response to therapy and development of complications. Our main aim is to identify, within the above-mentioned population, the subgroups of responder patients versus non-responder patients, i.e. those with a worse prognosis , who deserve greater attention and more frequent follow-up.

Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)

Background: More than 6.5 million people in the United States live with heart failure (HF), and more than a million new cases are diagnosed each year. Treatments have improved in recent years, but researchers want to understand more about how HF develops. To do this, they need to compare blood and other samples from many people with HF. Objective: To collect blood and other samples from people with HF. These samples will be used to identify and study proteins and other factors that may lead to decreased heart function over time. Eligibility: People aged 18 years and older with heart failure. Design: Participants will be asked to join the study based on a review of their medical records. They will have 1 study visit. They will provide a blood sample: About 3 tablespoons will be collected from a needle inserted into a vein. Other tests are optional: Participants may provide urine and stool samples. They may have a cotton swab rubbed on the inside of the mouth to collect DNA. Participants may also take 3 questionnaires. They will answer questions about dietary, social, and other factors that affect their health. Participants will receive compensation. Researchers will follow the participants health by monitoring their medical records for up to 5 years.

The WiSE®-UP Study (The WiSE System Utilization & Performance Study)

Observe to understand product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System

30 Days and 90 Days Heart Failure Re-Admission at Komfo Anokye Teaching Hospital

In Ghana, about 88.3 per cent of cardiac admissions are due to Heart failure, making it the leading cause of admission due to heart conditions. Despite improved knowledge on heart failure and an increasing array of evidence-based guideline treatment options, there is still a significant readmission rate worldwide. This may be due to the underutilization of these evidence-based therapies or a lack of proper follow-up on these patients. Recurrent hospital admission is an independent predictor of death in heart failure. Strategies aimed at providing increased support at discharge and effective follow-up may be associated with lower readmission risk. This study aims to assess the effect of extensive post-discharge counselling and effective phone-based follow-up on the 30-day and 90-day heart failure readmission rate at a tertiary hospital in Ghana. This is a single-centre, pilot randomised controlled trial of heart failure patients admitted to the Komfo Anokye Teaching Hospital

Multimodal Physiologic State Intelligence Study

The OMNIPHYS study will investigate whether multimodal ultrasound and other routinely collected clinical and physiologic data can be combined with artificial intelligence to characterize changes in a person's physiologic state over time. The study will examine cardiac, vascular, pulmonary, and systemic physiologic measurements and develop longitudinal models that describe baseline physiology, physiologic perturbation, compensation, deterioration, treatment response, and recovery. The study is observational and will not assign experimental treatments. The goal is to determine whether changes in multimodal physiologic patterns can be identified and characterized earlier and more reliably than conventional single-time-point assessment.

A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)

Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.

The Impact of Video-based Cardiac Rehabilitation Education in Patients With CIEDs

Cardiac rehabilitation has the beneficial effects of secondary prevention and social psychological and physical health status in patients with cardiovascular diseases. International and clinical guidelines currently recommend exercise training and rehabilitation for heart failure patients, which can effectively improve mortality and prognosis. However, few of these recommendations have specific recommendations for patients with cardiac implantable electronic devices. Currently the recommendations of cardiac rehabilitation include patients with coronary heart disease (acute coronary heart disease, any coronary revascularization, stable coronary disease or unstable angina), patients with heart failure, after cardiac surgery, and patients with high cardiovascular risk. Many of these patients may be implanted with cardiac implantable electronic devices. In 2011, 938 pacemakers, 140 cardiac resynchronization therapy and 149 implantable cardioverter defibrillators were implanted per million inhabitants in Europe. Therefore, among the groups with cardiac implantable electronic devices, cardiac rehabilitation plays a certain role. The purpose of this study is to evaluate whether video-based cardiac rehabilitation health education for patients with cardiac implantable electronic devices has significantly improved physical activity. This study is designed as a prospective, single center, double-blind, randomized controlled trial. Divided into an experimental group and a control group at a ratio of 1:1. The experimental group with cardiac implantable electronic devices will receive cardiac rehabilitation health education video intervention, and the control group will receive only health education. We aim to recruit 45 participants per group with a total of 90 participants.

iCaReMe Global Registry: Multinational Real-world Evidence in Cardiorenal and Metabolic Diseases

To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases

BIOSTREAM.HF HeartInsight

The main goal is to learn how HeartInsight is used in clinical routine care. HeartInsight is a heart failure monitoring and notification tool within BIOTRONIK's Home Monitoring System. HeartInsight combines patient data as collected by the implanted devices to alert the attending physicians to impending worsening of heart failure events of the patients. This study will create a sound and seamless documentation of approximately 150 HeartInsight alerts, their processing, subsequent interventions and disease progressions. The data will be analyzed to characterize and quantify the use of HeartInsight in a clinical routine set-up.The patient population consists of heart failure patients with BIOTRONIK CRT-D devices that support HeartInsight.

Accelerating Access and Improving Imaging in Heart Failure Care (A2I2HF) Pilot Study

This is a prospective, multicenter, cluster randomised trial which will assess the feasibility and acceptability of AI-assisted point of care echocardiography on HF detection and downstream care processes for patients with suspected HF discharged from the Emergency Department.

Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure

The goal of this study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 Left Ventricular Assist System when used for the treatment of advanced, refractory, left ventricular heart failure.

Heart Failure Efficacy and Research Trial (HEART) Platform

The Heart Failure Efficacy and Research Trial (HEART) Platform is a multicenter, randomized platform study designed to improve outcomes for patients with heart failure through the simultaneous and sequential evaluation of multiple interventions across the spectrum of heart failure.

Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure

Cross-over, 2-sequence, 2-treatment, 2-period single-centre, phase IV, randomized, open label study.

Mechanisms of Diuretic Resistance in Heart Failure, Aim 2

Randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations placebo/placebo, bendroflumethiazide/placebo, amiloride/placebo, and bendroflumethiazide/amiloride added to bumetanide.

The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART)

End-stage heart failure (HF) is a progressive illness with a mortality rate similar to most advanced cancers.Roughly 5% of patients with HF have end-stage disease that is refractory to medical therapy (stage D heart failure). When patients reach this point in their disease, the only treatments known to prolong life are cardiac transplantation or left ventricular assist devices. In patients who do not qualify for these options, or elect a palliative approach, inotropes are frequently used to improve hemodynamics through an increase in cardiac output and reduction in filling pressures. While inotropes provide profound symptomatic relief, these benefits are accompanied by significant risks of progressive adverse cardiac remodeling, arrhythmias, and sudden death. There is, therefore, an urgent need to develop strategies to reduce the dose or duration of inotrope use in the management of patients with stage D of HF.

Monitoring of the Sympathetic/Vagal Balance Through Multiparametric Analysis of Heart Rate Variability (HRV)

The autonomic nervous system (ANS) plays a crucial role in cardiovascular regulation by modulating heart rate in response to endogenous and environmental stimuli. Heart rate variability (HRV) analysis has been widely used as a non-invasive tool to assess autonomic function and the balance between sympathetic and parasympathetic activity. Although the physiological interpretation of some HRV parameters remains debated-particularly the low-frequency (LF) spectral component as an index of sympathetic activation-HRV remains an important method for evaluating autonomic cardiovascular control. Reduced HRV has been associated with adverse outcomes in several pathological conditions and physiologically declines with aging, mainly due to progressive neuronal loss at central and spinal levels. Among conditions characterized by autonomic dysfunction, cardiovascular autonomic neuropathy (CAN) represents a common complication of diabetes mellitus (DM) and metabolic syndrome. CAN, defined as impairment of autonomic control of the cardiovascular system, develops early in the disease course and is associated with increased mortality and a higher risk of cardiovascular and renal complications. Sodium-glucose cotransporter 2 inhibitors (SGLT2i), initially developed as glucose-lowering agents, have demonstrated significant cardiovascular and renal protective effects beyond glycemic control. Growing evidence suggests that these drugs exert sympathoinhibitory effects that may be beneficial not only in diabetic patients but also in conditions characterized by sympathetic overactivity. Preclinical and clinical studies have shown that SGLT2i influence autonomic regulation, including sympathetic control of renal function, with reported improvements in 24-hour blood pressure regulation and HRV parameters. Large randomized trials have further confirmed the cardioprotective effects of SGLT2i therapy. Studies such as EMBODY, EMPEROR-Reduced, and EMPEROR-Preserved have demonstrated improvements in HRV indices and significant reductions in cardiovascular death and hospitalization for heart failure, irrespective of diabetic status. Despite these findings, the mechanisms underlying these benefits remain incompletely understood. While reduced sympathetic activity has been proposed as a key mechanism, emerging evidence suggests that SGLT2i may also enhance vagal modulation. Therefore, the present study aims to investigate, in a larger population, the effects of SGLT2i therapy on sympathovagal balance using both spectral HRV parameters and additional indices, including the parasympathetic nervous system index (PNSi), sympathetic nervous system index (SNSi), and the Baevsky Stress Index.

KV-PREDICT Diagnostic Device in Patients With Heart Failure

This is a pilot, single-center, non-invasive interventional study evaluating the performance of KV-PREDICT, an investigational diagnostic medical device (Class IIa, not CE-marked), in adult patients with heart failure. During a single scheduled outpatient visit, the device is placed externally on the chest, over clothing, and records a single-lead ECG together with cardiac mechanical vibration signals for about 10 seconds. The study assesses whether the device can acquire signals of adequate quality and reproducibility to allow extraction of mechanical and electromechanical cardiac parameters (such as systolic and diastolic time intervals and the amplitudes of mechanical vibrations corresponding to the heart sounds S1-S4). The study does not aim to support clinical decisions, does not change patient management, and does not evaluate the diagnostic or predictive performance of the device. About 120 patients across NYHA functional classes I-III and different left-ventricular function profiles will be enrolled. No direct clinical benefit to participants is expected; anticipated risks are minimal given the non-invasive, brief procedure.

Elastic Band-Progressive Resistance Training (EB-PRT) for Sarcopenia Among Heart Failure Patients

Heart failure (HF) is a complicated clinical syndrome caused by structural and/or functional cardiac abnormalities that result in ineffective myocardial pumping. HF management has placed more emphasis on improving the prognostic factors which determine these poor clinical outcomes. More recently, the prognostic role of sarcopenia in HF has received particular attention. Defined as progressive and generalized decline in skeletal muscle mass, strength and physical performance due to aging, sarcopenia is definitely a common comorbid of HF which follows an age-specific disease epidemiology. Given muscle disuse is the most preventable and reversible factor of sarcopenia, more evidence points to the therapeutic value of resistance training (RT) for this debilitating condition. Nevertheless, the therapeutic effects of RT on improving sarcopenia and thereby the disease prognosis among HF patients is yet to be evaluated. Therefore, the sequential mixed method study including a pilot RCT will be conducted to evaluate the preliminary effect of a 14-week elastic band-progressive resistance training (EB-PRT) and a subsequent qualitative study to explore the subjects' engagement experience. The outcomes cover the whole set of defining characteristics including muscle mass, muscle strength and functional performance and the clinical outcomes which reflect HF disease severity and patient-reported HRQL.

Testing Heart Failure Resilience Intervention for Caregivers (HEROIC) in Advanced Heart Failure

This study will test the mechanisms of a multi-component, nurse-led, primary palliative care intervention, HEart failure Resilience Intervention for Caregivers (HEROIC) to improve caregiver mental well-being, patient health-related quality of life and unplanned acute care in the setting of advanced heart failure. The investigators will conduct a multi-site, randomized controlled trial to test proposed mechanisms of action in a large sample (N=500) of persons with heart failure and the caregivers. The investigators will also examine variation in response to HEROIC components by heart failure subgroup (ventricular assist device, heart transplant or medically managed heart failure).

First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF)

First in Human Clinical Investigation of the FIRE1 Device/System to evaluate the feasibility and safety of implanting the FIRE1 system in up to 50 stable HF patients.

A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart

This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure. In this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat/empagliflozin tablets, and the other group takes placebo/empagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between about 6 months and about 3.5 years. During this time, they can continue their regular treatment for heart failure. Participants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.