Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation
NCT06414265 · Heart Failure
RecruitingThe 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)
PhaseNA
TypeInterventional
Age65 Years
WhereTbilisi, Georgia + 2 more
SponsorInnovHeart
▾Tap for detailsClick for full details — eligibility, all locations, contacts HEART Camp Connect -Promoting Exercise in Adults With Heart Failure With Preserved Ejection Fraction
NCT05784753 · HFpEF - Heart Failure With Preserved Ejection Fraction
RecruitingThe goal of this study is to learn more about patients with heart failure with preserved ejection fraction (HFpEF) and exercise. Investigators want to see if meeting with a coach in person or by video conference will help these patients exercise, feel better, and change markers in their blood. Participants will be randomly placed in one of three groups for 18 months. All groups will have access to a fitness center and be given a watch and heart rate monitor to wear during exercise. The usual care group (control group) will have access to exercise videos via the medical fitness center and will not meet with a coach. The HEART Camp group will exercise and meet with their coach in-person at the medical fitness center. The HEART Camp Connect group will have access to exercise videos via the medical fitness center and will meet with their coach via videoconferencing. All participants will take part in an exercise test and study training prior to being randomized. At four data collection time points, participants will wear an activity monitor for 7 days each, have their blood drawn, and answer questions related to heart failure and exercise. Participants will also wear a heart rate monitor when they exercise and fill out a daily exercise diary.
PhaseNA
TypeInterventional
Age18 Years
WhereDetroit, Michigan, United States + 2 more
SponsorUniversity of Nebraska
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation
NCT06200207 · Heart Failure, Systemic Inflammation
RecruitingThe study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAlexander City, Alabama, United States + 239 more
SponsorNovo Nordisk A/S
▾Tap for detailsClick for full details — eligibility, all locations, contacts POWER Myocardial Fatigue Study: a Biomechanical Assessment of Contractility of Human Myocardium
NCT04899635 · Heart Failure, Fatigue; Muscle, Heart, Myocardial Dysfunction
RecruitingTo gain a comprehensive understanding of the biomechanical behaviour of human heart to explore the concept of myocardial fatigue in response to a temporal range of preload, afterload and drug-induced inotropy using in-vitro contractile assays.
Phase—
TypeObservational
Age18 Years – 85 Years
WhereCoventry, United Kingdom
SponsorUniversity Hospitals Coventry and Warwickshire NHS Trust
▾Tap for detailsClick for full details — eligibility, all locations, contacts CRF2 Agonist for the Treatment of Worsening Heart Failure
NCT06815471 · Worsening Heart Failure
RecruitingThis study assesses the effects of the investigational drug COR-1167 in subjects hospitalised due to worsening of heart failure (HF)
PhasePhase 2
TypeInterventional
Age18 Years – 85 Years
WhereIndianapolis, Indiana, United States + 54 more
SponsorCorteria Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF
NCT05934565 · Chronic Obstructive Pulmonary Disease, Chronic Heart Failure
RecruitingThe goal of this fully-remote randomized controlled trial is to test the efficacy of Mindful Steps in facilitating physical activity compared to usual standard of care among 136 patients with COPD and/or HF. The main question it aims to answer is can this intervention promote physical activity as measured by daily step counts in sedentary patients with COPD and/or HF. Participants will be randomized (1:1 ratio) to receive either the Mindful Steps intervention or usual care for 12 months, with both arms receiving a Walking for Health education booklet.
PhaseNA
TypeInterventional
Age40 Years
WhereBoston, Massachusetts, United States + 1 more
SponsorBeth Israel Deaconess Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
NCT06055504 · Non-ischemic Dilated Cardiomyopathy
RecruitingProspective, randomised, multicentre, open-label study to assess the non-inferiority of a personalised precision strategy for Sudden Cardiac Death (SCD) prevention in patients with non-ischemic dilated cardiomyopathy with Left Ventricular Ejection Fraction (LVEF) ≤35%
PhaseNA
TypeInterventional
Age18 Years
WhereSantiago de Compostela, A Coruña, Spain + 30 more
SponsorConsorcio Centro de Investigación Biomédica en Red (CIBER)
▾Tap for detailsClick for full details — eligibility, all locations, contacts EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF
NCT06161987 · Acute Decompensated Heart Failure
RecruitingEACH-ADHF: Early Comprehensive Rehabilitation in patients with ADHF study is a multi-center, parallel-group, randomized controlled trial designed to evaluate the effects of the early comprehensive rehabilitation including exercise and inspiratory muscle training, over a period of 6 weeks, on the quality of life of patients with ADHF.
PhaseNA
TypeInterventional
Age18 Years – 80 Years
WhereGuangzhou, Guangdong, China
SponsorGuangdong Provincial People's Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
NCT06964464 · Heart Failure With Reduced Ejection Fraction (HFrEF), Sudden Cardiac Death, Ventricular Arrhythmia
RecruitingThis prospective, multicenter, open-label, randomized comparative effectiveness trial, titled CARVTOP-ICD, evaluates the impact of carvedilol versus metoprolol succinate in patients with heart failure with reduced ejection fraction (HFrEF) and an implantable cardioverter defibrillator (ICD). The study will enroll 2,000 participants across 100 U.S. sites and includes an 18-month feasibility phase with 100 participants from 15 sites. Eligible participants must be currently treated with metoprolol succinate and willing to switch to carvedilol, with randomization in a 1:1 ratio. Participants will be followed for up to 3 years, with regular assessments including ICD interrogations, medication adherence, healthcare utilization, and quality of life surveys. The primary endpoint is the first occurrence of any ICD therapy (appropriate or inappropriate), cardiovascular (CV) hospitalization, or CV death. Secondary endpoints include ICD shock burden, healthcare utilization, and patient-reported quality of life. The trial aims to provide high-quality comparative data to address clinical equipoise surrounding the two commonly used beta-blockers in HFrEF management.
PhasePhase 4
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 12 more
SponsorUniversity of Rochester
▾Tap for detailsClick for full details — eligibility, all locations, contacts 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
NCT06397833 · Heart Failure, Decompensated Heart Failure
RecruitingAcorai 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)
Phase—
TypeObservational
Age18 Years
WhereUxbridge, Middlesex, United Kingdom
SponsorRoyal Brompton & Harefield NHS Foundation Trust
▾Tap for detailsClick for full details — eligibility, all locations, contacts Investigating the Impact of Nudging Cardiologists to Prescribe Guideline-directed Medical Therapy in Heart Failure Patients
NCT06844006 · Heart Failure
RecruitingThis study investigates the impact of a nudge-based intervention on improving guideline directed medical therapy (GDMT) prescription among cardiologists. Using a stepped wedge randomized controlled trial design, we assess whether digital decision support-leveraging home monitoring and clinical data-enhances adherence to guideline-recommended medication titration. The primary outcomes include HF related hospitalization rates and all cause mortality.
PhaseNA
TypeInterventional
Age18 Years
WhereEnschede, Overijssel, Netherlands
SponsorMedisch Spectrum Twente
▾Tap for detailsClick for full details — eligibility, all locations, contacts Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)
NCT04962711 · Heart Failure
RecruitingThis is a prospective study in which a process of identifying and reducing heart failure (HF) risk will be applied to cancer survivors \>55 years old with chemotherapy \>5 years ago. The overall goal of this study to identify the feasibility and value of risk-guided cardiac rehabilitation (exercise, risk factor modification, and behavioural support) as a component of survivorship care.
PhaseNA
TypeInterventional
Age40 Years – 85 Years
WhereMelbourne, Victoria, Australia
SponsorBaker Heart and Diabetes Institute
▾Tap for detailsClick for full details — eligibility, all locations, contacts CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis
NCT07207811 · Transthyretin Amyloid Cardiomyopathy (ATTR CM)
RecruitingThis study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 284 more
SponsorNovo Nordisk A/S
▾Tap for detailsClick for full details — eligibility, all locations, contacts Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
NCT06384963 · Heart Failure With Reduced Ejection Fraction
RecruitingThe goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out. The main questions the trial aims to answer are: * Is the new type of pacemaker safe? * Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)? Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients.
PhaseNA
TypeInterventional
Age22 Years
WhereAdelaide, South Australia, Australia + 2 more
SponsorCeryx Medical Australia
▾Tap for detailsClick for full details — eligibility, all locations, contacts Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts
NCT06218199 · Heart Failure, Congestive
RecruitingThe DART-HA study is a single-center, open label, trial intended to evaluate the clinical efficacy of standard treatment options for congestive heart failure (observation, diuretic or afterload reduction therapy) in patients without new symptoms who have developed abnormalities of the HeartLogic heart failure diagnostic feature.
PhasePhase 4
TypeInterventional
Age19 Years
WhereHuntsville, Alabama, United States
SponsorHeart Center Research, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Development of Novel Physiological CMR Methods in Health and Disease
NCT03854071 · Heart Failure, Pulmonary Hypertension, Myocardial Infarction
RecruitingPhysiological cardiovascular stress test plays a crucial role in the assessment of patients with suspected heart disease. There are several methods of cardiac physiological stress tests and each of them offer varied insight into cardiac physiological adaptation: passive leg raise, intra-venous fluid challenge, pharmacological stressors and physical exercise stress test. Echocardiography, which is the mainstay for the non-invasive rest/stress assessment of the left ventricular (LV) haemodynamics has several limitations. Novel methods of CMR imaging allow to map intra-cardiac flow in three-dimension using novel flow acquisitions. These novel flow acquisitions are called four-dimensional flow CMR, where the fourth dimension is time. Additionally, traditional cine CMR imaging for functional assessment can now be done without breath-holds using advanced acceleration methods, allowing them to be used during exercise. A comprehensive understanding of functional-flow coupling at rest, during increased pre-load (fluid challenge) to the heart or during exercise, is lacking in the literature. There is an important need to validate these novel CMR methods for developing mechanistic insight into physiological cardiac adaptation to increased pre-load or to exercise in health and how it alters in heart disease.
PhaseNA
TypeInterventional
Age20 Years – 80 Years
WhereSheffield, England, United Kingdom
SponsorSheffield Teaching Hospitals NHS Foundation Trust
▾Tap for detailsClick for full details — eligibility, all locations, contacts Characterization of Patients With Cardiomyopathy to Identify Critical Patients Candidates for Cardiac Transplantation
NCT06813443 · Cardiomyopathies, Amyloidosis Cardiac, Fabry Disease
RecruitingThe study aims to identify new diagnostic and prognostic markers for CMP that can help predict disease progression. In particular, the study will focus on microRNAs (miRNAs) and spatial transcriptomics, which are emerging techniques that may provide insights into the underlying disease mechanisms. By understanding these markers, the investigators hope to improve the way the investigators diagnose and manage CMP, particularly in terms of predicting progression to heart failure or heart transplantation. The study will evaluate patients with hypertrophic cardiomyopathy (e.g., sarcomeric forms, Anderson-Fabry disease, AL, and TTR cardiac amyloidosis), dilated cardiomyopathy and arrhythmogenic cardiomyopathy. These patients will undergo clinical evaluations, including ECG, echocardiograms, CMR, biopsy analysis, and genetic testing, as well as molecular studies such as transcriptomics and miRNA analysis. This comprehensive approach aims to identify potential new biomarkers for diagnosing and predicting the disease course.
Phase—
TypeObservational
Age12 Years
WhereBologna, Emilia-Romagna/Bologna, Italy + 2 more
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
▾Tap for detailsClick for full details — eligibility, all locations, contacts Naples Federico II Intensive Cardiac Care Unit Registry (Naples FED2-ICCU Registry)
NCT06162247 · Acute Cardiovascular Disease, Acute Coronary Syndrome, Acute Heart Failure
RecruitingThis protocol proposes to prospectively evaluate current epidemiology, pharmacologic and invasive management and clinical outcomes of patients with acute cardiovascular diseases admitted at our ICCU.
Phase—
TypeObservational
Age18 Years
WhereNaples, Italy
SponsorFederico II University
▾Tap for detailsClick for full details — eligibility, all locations, contacts The Hepatitis C Transplant Collaborative
NCT04493385 · Transplant; Failure, Heart, Hepatitis C
RecruitingIn this study we seek to test the hypothesis that safety and clinical outcomes after cardiac transplantation utilizing HCV NAT+ donor organs as currently performed are acceptable.
Phase—
TypeObservational
Age18 Years
WhereDallas, Texas, United States
SponsorBaylor Research Institute
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mechanisms of Brain-Heart Injury of Post-Intracranial Hemorrhage
NCT06906432 · Subarachnoid Hemorrhage, Aneurysmal, Cerebrocardiac Syndrome, Mass Spectrometry
RecruitingIntracranial hemorrhage is a condition characterized by high mortality rates and suboptimal functional outcomes. It precipitates both direct brain injury and subsequent secondary injuries, including delayed cerebral ischemia, brain edema, and hydrocephalus. Complications such as cardiac injury may also arise, categorizing them within the cerebrocardiac syndrome (CCS). The clinical spectrum of CCS encompasses acute myocardial injury, acute coronary syndrome, left ventricular systolic and diastolic dysfunction, cardiac arrhythmias, and sudden cardiac death, all of which are associated with increased mortality and deterioration in patient status. The precise pathophysiological mechanisms underlying both cerebral and cardiac injuries remain enigmatic, and the implications for diagnosis and therapeutic strategies are yet to be fully explored. In this study, we propose to enroll patients with intracranial hemorrhage who will undergo conventional treatment and comprehensive multidisciplinary evaluations. Our observational research is grounded in a multimodal omics and imaging approach, aimed at investigating both local and systemic injuries subsequent to intracranial hemorrhage. This comprehensive strategy is intended to facilitate precise diagnosis, risk stratification, and clinical decision-making, while also shedding light on the pathophysiological mechanisms involved. The primary objectives of this research are to address the following key questions: * \[Question 1\] What are the pathophysiological mechanisms underlying cardiac injury in patients with intracranial hemorrhage? * \[Question 2\] What are the pathophysiological mechanisms responsible for early and delayed brain injuries following intracranial hemorrhage?\"
Phase—
TypeObservational
Age18 Years – 80 Years
WhereBeijing, Beijing Municipality, China
SponsorBeijing Tiantan Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts