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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 | Impact on Atrial Remodeling of Dapaglifozin in Patients With Heart Failure . | Recruiting | Heart Failure | Drug - Dapagliflozin | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia, Spanish Society of Cardiology, Other, Other | 18 Years - N/A | Phase 3 | Interventional | Dapagliflozin reduces the risk of de novo heart failure (HF) in diabetics and, recently, it has shown to improve the prognosis of patients with HF and reduced left ventricular ejection fraction (HFrEF), by preventing HF decompensations and cardiovascular death. The benefit showed by dapagliflozin in HFrEF was irrespective of diabetes status and glycemic control, which raises the question of which mechanisms are underlying apart from SGLT2 inhibition. In addition, the impact of dapagliflozin on cardiac remodeling parameters, as assessed by echocardiography and biomarkers, is not well established. In particular, left atrial (LA) remodeling represents a relevant prognostic marker, which has received a greater attention in the last years in the context of new imaging tools. The purpose of this study is to assess the effect of dapagliflozin therapy over a period of 6 months in LA remodeling parameters, including geometry and function, as well as complementary biomarkers in patients with chronic HF regardless left ventricular ejection fraction (LVEF). This protocol will allow for evaluation of improved understanding of the interplay between dapagliflozin and LA function , biomarkers, remodeling and outcomes, and will carefully assess such relationships within important cohorts of subjects, such as those with reduced and preserved LVEF. This protocol will also generate a biorepository of well-handled and carefully considered biomarkers, which will allow a better understanding of dapagliflozin mechanism of action. | ||
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Clinicaltrials.gov | Dapagliflozin in Diabetic Patients (Type 2) With Decompensated Heart Failure | Completed | Heart Failure | Drug, Drug - Dapagliflozin, insulin | Assiut University, Other | 18 Years - 80 Years | Phase 4 | Interventional | We hypothesize that Dapagliflozin could improve the diuretic response in diabetic patients with acute decompensated heart failure owing to its diuretic effect in addition to improvement of blood glucose level without remarkable effect on kidney function or electrolytes. | ||
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Clinicaltrials.gov | Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68) | Recruiting | Acute Heart Failure, Heart Failure | Drug, Drug - Dapagliflozin, Placebo | The TIMI Study Group, AstraZeneca, Worldwide Clinical Trials, Other, Industry, Other | 18 Years - N/A | Phase 4 | Interventional | This is an international, multicenter, parallel-group, randomized, double-blind, placebo-controlled trial in patients who have been stabilized during hospitalization for acute heart failure, evaluating the effect of in-hospital initiation of dapagliflozin versus placebo on the clinical outcome of cardiovascular death or worsening heart failure. | ||
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Clinicaltrials.gov | Safety and Effectiveness of SGLT-2 Inhibitors in Patients With Heart Failure and Diabetes | Completed | Heart Failure, Diabetes | Drug, Drug - Dapagliflozin, Placebo | University of Dundee, European Foundation for the Study of Diabetes, Other, Other | 18 Years - 75 Years | Phase 4 | Interventional | Patients with diabetes are at increased risk of developing heart failure (HF) which can lead to increased shortness of breath, reduced ability to exercise and in some cases premature death as the heart becomes less efficient at pumping blood around the body. However the treatment options for such patients remain limited. This study will test the safety and benefits of using a new class of drug, the SGLT2 Inhibitor (Dapagliflozin), in treating HF and diabetes. Participants will have a Magnetic Resonance Imaging (MRI) scan of the heart, to measure the efficiency and the extent of thickening of the heart muscle before they start on treatment of dapagliflozin, or placebo for one year. They will also do exercise testing on an exercise bike (if capable) and a walking test plus fill in some questionnaires on how their heart failure affects their quality of life. Participants will then continue as normal with currently prescribed medication for their diabetes and heart failure. After a year the tests will be repeated to determine if patients receiving Dapagliflozin benefited more than those who weren't on the drug. This study is funded by the European Foundation for the Study of Diabetes (EFSD) | ||
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Clinicaltrials.gov | Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS) | Recruiting | Anemia, Heart Failure | Drug, Drug - Dapagliflozin, Placebo | Xiangtan Central Hospital, Second Xiangya Hospital of Central South University, ZhuZhou Central Hospital, Other, Other, Other | 18 Years - 100 Years | Phase 4 | Interventional | The primary objective of this study is to investigate the hemoglobin change and association between hemoglobin change and readmissions due to heart failure, and all-cause death in patients with heart failure treated with dapagliflozin or placebo. | ||
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Clinicaltrials.gov | Dapagliflozin Heart Failure Readmission | Recruiting | Heart Failure, Diabetes | Drug, Drug - Dapagliflozin, Placebo | Emory University, Other | 18 Years - 80 Years | Phase 4 | Interventional | This study will be the first trial to evaluate the safety and efficacy of dapagliflozin treatment in preventing readmissions/ER visits/urgent clinic visits, and death in patients with and without T2D after admission for heart failure. Treatment with SGLT2-i has been shown to reduce both heart failure hospitalizations and mortality in patients with established heart disease. However, the time of initiation of SGLT2-i therapy has not been evaluated in patients with HF. In addition, the impact of treatment on HF symptoms quality of life, resource utilization, and cost-effectiveness of dapagliflozin versus placebo will be evaluated. The results of this study have great potential to impact and facilitate care and to change current clinical guidelines in the management of patients with heart failure. | ||
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Clinicaltrials.gov | Dapagliflozin Effects on Cardiovascular Events in Patients With an Acute Heart Attack | Recruiting | Acute Myocardial Infarction, Heart Failure | Drug, Drug - Dapagliflozin, Placebo | AstraZeneca, Uppsala University, Industry, Other | 18 Years - 130 Years | Phase 3 | Interventional | This study will evaluate the effect of dapagliflozin versus placebo, given once daily in addition to Standard of Care (SoC) therapies for patients with myocardial infarction (MI), for the prevention of hospitalisation for heart failure (HHF) or cardiovascular (CV) death. |
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