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Integrated Clinical Trials is a virtual database currently indexing clinical trials from: EU Clinical Trials Register and ClinicalTrials.gov.
(last updated: Nov 28, 2022)
Clinical Trials Information| Database | Title | Recruitment | Conditions | Intervention | Sponsored By | Gender | |||||
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Clinicaltrials.gov | 123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging on a Small Field of View-High Efficiency Cardiac SPECT System | Completed | Heart Failure, Cardiomyopathy | Drug, Other - AdreView, Single Photon Emission Computed Tomography | Timothy M. Bateman, GE Healthcare, Other, Industry | 18 Years - 90 Years | Phase 4 | Interventional | The purpose of this study is to demonstrate correlation of the H/M ratio of AdreView when derived from a large field of view Anger SPECT system and from a small field of view high sensitivity (CZT) SPECT system. | ||
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Clinicaltrials.gov | 123I-mIBG SPECT Imaging | Completed | Heart Failure, Coronary Artery Disease | Drug - Radioisotope | Ottawa Heart Institute Research Corporation, GE Healthcare, Other, Industry | 18 Years - N/A | Phase 3 | Interventional | This study is being done with a radioisotope, 123I-mIBG (Adreview), to develop a nuclear diagnostic imaging test for patients with decreased heart function which can be used to predict the progression of the heart disease and provide the appropriate clinical treatment. The types of patients to be studied include patients who have had a heart attack where heart muscle may be damaged and patients diagnosed with heart failure who have enlarged hearts. Both conditions may cause poor muscle contraction and disturbances in electrical signal conduction. There will also be a control group of participants with no evidence of heart disease. 123I-mIBG has been shown to be effective in assessing the areas of the heart being activated involuntarily by the sympathetic nervous system (SNS). 123I-mIBG is an iodine based radioisotope that is chemically similar to norepinephrine (NE) in the heart. NE is responsible for the way the SNS regulates heart functions such as heart rate and the force of heart contractions. NE acts automatically to maintain a homeostasis or balance within the SNS. The amount of 123I-mIBG, mimicking NE, that appears on the nuclear image using the heart-to-mediastinum ratio (H/M ratio), was predictive of the progression of heart failure, arrhythmias (irregular heartbeats) and cardiac death. Two different types of single photon emission computed tomography (SPECT) imaging will be used: standard SPECT and cadmium-zinc-telluride (CZT) SPECT. The investigators hypothesize that CZT SPECT will have greater H/M ratios than standard SPECT imaging. | ||
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Clinicaltrials.gov | 1 Year Post Discharge Prognostic Model From the National Heart Failure Audit (NHFA) | Unknown status | Heart Failure | Other - Heart Failure Management | University College, London, National Institute for Cardiovascular Outcomes Research, British Society for Heart Failure, Other, Other, Other | 18 Years - N/A | Observational | The aim of the study is to develop and assess a prognostic model for patient's survival up to 1 year after unscheduled acute heart failure hospital admission in England and Wales. | |||
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Clinicaltrials.gov | Aachen Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation | Completed | Heart Failure, Mitral Regurgitation | Device - PTMA Implant | Viacor, Industry | 50 Years - N/A | Phase 1/Phase 2 | Interventional | Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device | ||
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Clinicaltrials.gov | The "ABCDE" Score as a Five-step Vascular Ultrasound Examination in Heart Failure | Recruiting | Heart Failure, Atherosclerosis | Diagnostic Test - ultrasound examination | Azienda Ospedaliera Universitaria Integrata Verona, University of Palermo, University Of Perugia, IRCCS Sacro Cuore Don Calabria di Negrar, Other, Other, Other, Other | 18 Years - 90 Years | N/A | Interventional | Heart failure (HF) is a clinical syndrome caused by structural and/or functional cardiac abnormalities, resulting in a reduced cardiac output and/or elevated intra-cardiac pressures at rest or during stress. It is the leading cause of hospitalization in Internal Medicine departments. This study aims at exploring evidence of the importance of ultrasound in HF both for hospitalized patients and in the follow up. Ultrasound may be used as a recovery monitoring instrument at the bedside and also as a global cardiovascular assessment tool for these patients. HF represents an exciting opportunity to create an integrative ultrasound approach in Internal Medicine/Geriatric departments.The Authors plan a five-step ultrasound examination to evaluate and monitor HF patients during hospitalization and follow-up. They call this examination: the "ABCDE" score. It includes the evaluations of A, the Ankle-brachial index (ABI), B, the B-lines, C, the Carotid intima media thickness (CIMT), D, the Diameter of the abdominal aorta and of the inferior cave vein and E, the echocardiographic assessment of the ejection fraction.This score represent an integrative ultrasound approach in Internal Medicine/Geriatric departments. | ||
Clinicaltrials.gov | Abdominal Nerve Blockade in Chronic Heart Failure. | Completed | Heart Failure | Drug - splanchnic nerve anesthesia with a local anesthetic | Duke University, Other | 18 Years - N/A | Phase 1/Phase 2 | Interventional | Patients with chronic heart failure and undergoing right heart catheterization will be enrolled in this study. Subjects will undergo catheterization of the heart to obtain central cardiac pressure and other cardiac hemodynamic parameters. Subsequently, the subject will undergo a regional nerve block of the splanchnic nerves. This study will be a prospective, uncontrolled clinical trial. The study will not be controlled as invasive monitoring of hemodynamics will be performed, allowing clear demonstration of a cause-effect relationship. The goal of the study is to provide proof of concept. Patients will undergo detailed physiological testing. | ||
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Clinicaltrials.gov | Ability of L-carnitine to Prevent Heart Damage in Breast Cancer Patients Receiving Anthracycline Chemotherapy | Completed | Heart Failure | Drug - L-carnitine | Ottawa Heart Institute Research Corporation, Canadian Institutes of Health Research (CIHR), Other, Other | Female | 18 Years - N/A | Phase 2/Phase 3 | Interventional | Breast cancer is very common and afflicts 1 in 9 North American women. The treatment of breast cancer often requires the use of chemotherapy including "anthracyclines". Anthracyclines can damage the heart resulting in heart failure and even death. Clinicians and researchers are continually seeking methods that will reduce the toxic effects of anthracycline treatment. L-carnitine is a substance that is produced naturally in the body and is required for normal heart function. Animal studies have suggested that L-carnitine protects the heart from the effects of anthracyclines, however this has not been verified in humans. This study will assess the potential role of L-carnitine in the prevention of anthracycline induced heart damage. The investigators will enroll 144 patients into this study. Patients will be randomly assigned to L-carnitine therapy or to standard care (no L-carnitine therapy). Patients in the L-carnitine group will receive oral and intravenous L-carnitine prior to and after their anthracycline therapy. Patients will undergo regular follow up and testing to assess heart function. The investigators believe that patients treated with L-carnitine will benefit and have fewer complications associated with anthracycline treatment. | |
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Clinicaltrials.gov | Ability of Metoprolol to Alter the Exercise Induced Elevation of Catecholamines | Unknown status | Heart Failure | Drug, Drug - Metoprolole (Selo-Zok ®), Placebo | Rigshospitalet, Denmark, Danish Heart Foundation, Other, Other | Male | 18 Years - 30 Years | Phase 4 | Interventional | Heart failure is a frequent disease in Denmark, and it is associated with very high mortality. Around 60,000 people in Denmark have heart failure, and there is about 11,000 hospitalizations every year due to this disease. From the time of diagnosis, patients survive an average of 4-5 years. A critical illness mechanism in heart failure is that these patients have high blood levels of catecholamines; epinephrine and norepinephrine, which is stress hormones from the sympathetic nervous system. Standard treatment of heart failure is with the two medical preparations betablockers and ACE-inhibitors. It is not known what effect betablocker-treatment have on blood concentration of epinephrine and norepinephrine. It is the purpose of this study, to investigate the effect of Selo-Zok ® (metoprolol) on the blood concentration of epinephrine and norepinephrine. This is done by creating a stress condition for the body, in this case with the bicycle test, while doing blood samples to determine the concentration of catecholamines. This will be done by 1-week treatment of tablet Selo-Zok ® followed by 1-week treatment of placebo (a substance with no medical effect). Blood samples will be taken to determine small changes in inheritance material (DNA) in the form of point mutations also called single nucleotide polymorphisms, since these changes can affect how we respond to metoprolol treatment. | |
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Clinicaltrials.gov | Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation | Completed | Heart Failure, Recurrent Atrial Fibrillation | Procedure, Drug, Procedure - AVATAR-AF ablation, Anti-Arrhythmic therapy, Conventional AF ablation | Imperial College London, Other | 18 Years - 80 Years | N/A | Interventional | A streamlined AF ablation procedure done without PV mapping as a daycase is more effective than anti-arrhythmic drugs at reducing all hospital episodes for recurrent atrial fibrillation. | ||
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Clinicaltrials.gov | Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD | Completed | Heart Failure | Procedure, Drug - Atrial Fibrillation ablation, Amiodarone | Texas Cardiac Arrhythmia Research Foundation, Casa Sollievo della Sofferenza IRCCS, Catholic University, Italy, Southlake Regional Health Centre, Stanford University, University of Kansas, The University of Texas Medical Branch, Galveston, University of Foggia, Sutter Health, Other, Other, Other, Other, Other, Other, Other, Other, Other | 18 Years - N/A | Phase 4 | Interventional | 1. To determine if catheter-based atrial fibrillation (AF) ablation is superior to Amiodarone treatment for symptomatic persistent/permanent AF in ICD/CRTD patients with an impaired left ventricular function. 2. Hypothesis: AF ablation is better than Amiodarone for subjects with symptomatic persistent or permanent AF and impaired LV function in terms of recurrence of AF, quality of life, 6-minute walk distance, EF and total number of hospitalizations. | ||
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Clinicaltrials.gov | AC6 Gene Transfer in Patients With Reduced Left Ventricular Ejection Fraction Heart Failure | Withdrawn | Heart Failure | Drug, Drug - Ad5.hAC6, Placebo | Renova Therapeutics, Industry | 18 Years - 80 Years | Phase 3 | Interventional | To determine the safety and efficacy of an intracoronary injection of adenovirus 5 encoding human adenylyl cyclase 6 (RT-100) in patients with heart failure with reduced left ventricular ejection fraction (HFrEF) in a Phase 3 clinical trial. | ||
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Clinicaltrials.gov | Access Natriuretic Peptide Assay(s) Pivotal - Emergency Department Subject Enrollment and Specimen Collection | Recruiting | Heart Failure | Diagnostic Test - Access Immunodiagnostic Products | Beckman Coulter, Inc., Industry | 21 Years - N/A | Observational | The purpose of the pivotal study is to collect blood specimens and clinical data from patients suspected of having Heart Failure (HF), which will be tested at a future date on Natriuretic Peptide assay(s) to validate diagnostic cutoffs and assess HF severity. | |||
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Clinicaltrials.gov | Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator | Recruiting | Heart Failure | Device - Wearable Cardioverter Defibrillator | Zoll Medical Corporation, Industry | 18 Years - N/A | Observational | Evaluate data accuracy of cardiac acoustic biomarkers (CABs) recorded by the Wearable Cardioverter Defibrillator (WCD) as compared to the AUDICOR AM acoustic cardiography recorder. | |||
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Clinicaltrials.gov | Acetazolamide and Spironolactone to Increase Natriuresis in Congestive Heart Failure | Completed | Heart Failure | Drug, Drug, Drug - Combination therapy with acetazolamide and low-dose loop diuretics, High-dose loop diuretics, Upfront therapy with oral spironolactone | Hasselt University, Ziekenhuis Oost-Limburg, Universitaire Ziekenhuizen Leuven, Other, Other, Other | 18 Years - N/A | Phase 4 | Interventional | This study has two primary objectives: 1. To compare combination therapy with acetazolamide and low-dose loop diuretics versus high-dose loop diuretics (standard of care) in patients with acute decompensated heart failure at high risk for diuretic resistance. 2. To demonstrate the safety and efficacy of upfront therapy with spironolactone in addition to loop diuretic therapy in patients with acute decompensated heart failure at high risk for diuretic resistance. | ||
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Clinicaltrials.gov | Acetazolamide in Patients With Acute Heart Failure | Unknown status | Heart Failure, Acute Heart Failure | Drug, Drug - Acetazolamide, Placebo | University of Sao Paulo General Hospital, Other | 18 Years - N/A | Phase 3 | Interventional | Introduction: Recent studies have suggested that the use of acetazolamide may assist in the vol- ume management of patients with decompensated heart failure (HF). However, prospective and randomized comparison in patients with HF and optimized diuretic therapy has not been described. Objective: The aim of this study was to evaluate the effectiveness and safety of the use of acetazolamide versus placebo in volume control in patients with decompensated HF. Methodology: For this, a unicentric, randomized, double blind and prospective study will be performed in a comparative manner. Hospital data (test results, medical outcomes, drug dose, complications) of patients will be analyzed for safety and effectiveness. Expected results: The use of acetazolamide as an adjuvant treatment is superior to the standard strategy for volume control in patients with decompensated HF. | ||
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Clinicaltrials.gov | ACT-HF: Attention, Cognition and Self-Management in Heart Failure | Completed | Heart Failure | University of Chicago, Sigma-Tau Research, Inc., Other, Industry | 18 Years - 75 Years | Observational | This study is designed to determine if a relationship exists between problems with memory, attention, learning, insight and executive function and self management in heart failure. | ||||
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Clinicaltrials.gov | activeDCM - Interventional Clinical Trial of Individualized Activity and Exercise Programs to Improve Outcome in Dilated Cardiomyopathy Guided by Longitudinal Biosensing With Apple Watch | Not yet recruiting | Cardiomyopathy, Dilated, Heart Failure | Behavioral - Individualized excercise | University Hospital Heidelberg, Apple Inc., The German Heart Foundation, Informatics for Life, e-Cardiology, German Cardiac Society, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Other, Industry, Other, Other, Other, Other, Other | 18 Years - 65 Years | N/A | Interventional | The influence of an individualized sports program on dilated cardiomyopathy patients will be investigated in a randomized, prospective intervention study. 300 patients with dilated cardiomyopathy are included and examined over a period of 13 months. All participants will receive an Apple Watch, which serves for monitoring of activity and symptoms.The primary endpoint of the study is the change in maximum oxygen intake. In addition, the changes in well-being, objective parameters of cardiac function and the subject's compliance to his excercise program are of interest as secondary endpoints and for further exploratory research. In addition, the safety of a personalized sports program is evaluated. Molecules circulating in the blood (including proteins, RNA) are beeing measured at the beginning and in the course of the training program in order to be able to derive a connection between the training and the changed cardiovascular function. A gene analysis will be carried out, which serves to identify the genetic requirements of protective excercise. | ||
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Clinicaltrials.gov | Activity at Pulse Pressure Above an Individual Threshold in Patients With LVAD | Completed | Heart Failure | Behavioral - Daily physical activity | Hannover Medical School, Other | Male | 45 Years - 65 Years | N/A | Interventional | Pilot study in patients with continuous flow left ventricular assist device (cfLVAD) to proof the feasibility of a specific individual training at home aimed to increase pulse pressure above a predefined threshold which might attenuate the loss of arterial wall thickness. Hypothesis: Increasing daily physical activity near to normal (> 10.000 steps per day) with a pre-defined level of pulse pressure (intensity) is a realizable and feasible approach to investigate changes in arterial wall thickness and cardio-respiratory capacity in cfLVAD patients. | |
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Clinicaltrials.gov | Activity-Aware Prompting to Improve Medication Adherence in Heart Failure Patients | Completed | Heart Failure, Cardiovascular Diseases | Other - Prompting | Washington State University, University of California, Irvine, Other, Other | 21 Years - N/A | N/A | Interventional | The long-term objective of this project is to improve human health and impact health care delivery by developing intelligent technologies that aid with health monitoring and intervention. The immediate objective of this project is to design, evaluate and validate machine learning-based software algorithms that recognize daily activities, provide activity-aware medicine reminder interventions and provide insights on intervention timings that yield successful compliance. The investigators hypothesize that many individuals with needs for medicine intervention can be more compliant with their medicine regimen if prompts are provided at the right times and in the right context. The investigators plan to accomplish these objectives by 1) enhancing and validating software algorithms that recognize daily activities and activity transitions, 2) developing and validating activity-aware medicine prompting interventions for mobile devices, and 3) designing technologies to analyze medicine reminder successes and failures. The proposed work will partner real-time methodologies for validation and algorithmic development with smart phone data, utilize novel activity discovery algorithms, and employ activity recognition and prediction algorithms in the development of activity-aware prompting. | ||
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Clinicaltrials.gov | Acupuncture for Individuals With Stable Angina | Terminated | Angina, Stable, Chest Pain, Microvascular Angina, Heart Failure | Other, Other - Acupuncture, Non-pain related video health education | University of Illinois at Chicago, National Institute of Nursing Research (NINR), Other, NIH | 21 Years - N/A | N/A | Interventional | This RCT aims to determine if it is possible to perform acupuncture on men and women diagnosed with stable angina who have symptoms, chest pain, and/or chest discomfort. The investigators want to determine if acupuncture reduces the pain and other symptoms of angina, chest pain, and chest discomfort. The investigators also want to examine whether this study is acceptable to the participants, and by carrying out this study the investigators will be able to tell how many participants they will need in a future larger study to further test acupuncture to reduce the symptoms of angina in women. |
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