Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment
Tricuspid regurgitation (TR) is a public health problem: moderate / severe TR are common,
especially in ageing populations, and affect 4% of the population >75 years old, totaling
approximately 1.6 million in the US and 3 million in Europe. TR is associated with an
...
Age: 18 years - 66+
Gender: All
Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
The clinical benefits of the dual Sodium-Glucose cotransporter (SGLT) 1 and 2-inhibition have
recently been reported in two clinical trials. The SOLOIST reported the benefits of
sotagliflozin in Type-2 Diabetes Mellitus (T2DM) patients hospitalized for worsening of ...
Age: 18 years - 66+
Gender: All
ERTU-SODIUM: Study on the Effects of Ertugliflozin on Sodium Storage, Interstitial Volume, and Plasma Volume in HFrEF
The overall hypothesis is that treatment with the SGLT2 inhibitor Ertugliflozin induces a differential regulation in interstitial fluid vs plasma volume, with more reduction of the volume from the interstitial fluid than from the circulating plasma volume, which results...
Age: 18 years - 66+
Gender: All
A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)
The purpose of this study is to evaluate the efficacy and safety of vericiguat in
participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically
those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart
...
Age: 18 years - 66+
Gender: All
Comparative Effectiveness of Telemedicine in Primary Care
Leveraging a natural experiment approach, the investigators will examine rapidly changing
telemedicine and in-person models of care during and after the COVID-19 crisis to determine
whether certain patients could safely choose to continue telemedicine or
telemedic...
Age: 19 years - 66+
Gender: All
Mobile Integrated Health in Heart Failure
The purpose of this study is to compare how two different types of care after a
hospitalization reduce hospital readmissions and symptom burden. The two types of care are a
Transitions of Care Coordinator and Mobile Integrated Health. In the Transitions of Care
Co...
Age: 18 years - 66+
Gender: All
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF
The objective of this clinical evaluation is to assess the safety and initial effectiveness of catheter-based unilateral ablation of the right greater splanchnic nerve (GSN) in subjects having heart failure with preserved ejection fraction (HFpEF).
Age: 40 years - 66+
Gender: All
Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study
Prospective, randomized, open-label, international, multi-center clinical study to evaluate
the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with
heart failure and reduced ejection fraction (HFrEF).
Age: 18 years - 66+
Gender: All
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized,
single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of
care. Patients to be included will have NYHA functional class III symptoms and a left
...
Age: 18 years - 66+
Gender: All
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventri...
Age: 18 years - 66+
Gender: All
EMPEROR-HF: A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF)
Chronic heart failure (HF) is a progressive syndrome characterized by the inability of the heart to provide adequate blood supply to meet the metabolic demand of different tissues or to be able to do so only at the expense of elevated left ventricle filling pressure. HF...
Age: 18 - 45 years
Gender: All
ToRsemide compArisoN with furoSemide FOR Management of Heart Failure (TRANSFORM-HF)
An approximately 6000-patient, randomized, unblinded, two-arm, multicenter clinical trial comparing torsemide with furosemide among patients hospitalized for heart failure. 1:1 randomization to either oral torsemide OR oral furosemide (dosing at discretion of local pr...
Age: 18 - 85 years
Gender: All
DELIVER - An International, Double-blind, Randomised Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients with Heart Failure with Preserved Ejection Fraction (HFpEF)
The study is designed to determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the composite of CV death and HF events (hospitalisation for HF or urgent HF visit) in patients with HF and preserved systolic function.
This is ...
Age: 18 - 85 years
Gender: All
An Exploratory, Randomized, Double-blind, Placebo-controlled, Parallel Arm Trial of the Safety and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Patients with Worsening Heart Failure
Sotagliflozin (Sanofi code SAR439954, Lexicon code LX4211) is an orally administered small molecule, the first dual inhibitor of sodium-glucose co-transporter 1 and 2 (SGLT1 and SGLT2), formulated as 75 mg and 200 mg coated tablets. The compound, a member of the pharmac...
Age: 18 - 85 years
Gender: All
HEART-FID: A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency
This is a double-blind, multicenter, prospective, randomized, placebo-controlled study to assess the effects of IV FCM compared to placebo on the 12-month rate of death, hospitalization for worsening heart failure, and the 6-month change in 6 minute walk test (6MWT) for...
Age: 18 - 85 years
Gender: All
PROVIDE-HF: Patient Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (Sacubitril/Valsartan) in Heart Failure
This is a prospective cohort study of 1500 chronic HF patients that will also examine and describe retrospective electronic health record data. We will use the PCORnet (Patient Centered Outcomes Research Network, see "data sources" below) infrastructure to (1) identify ...
Age: 18 - 45 years
Gender: All
GALACTIC-HF: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction
HF is a clinical syndrome marked by impaired cardiac contractility and is a final pathway for many diseases that affect the heart. HF affects over 26 million people worldwide, with more than 3.5 million people newly diagnosed every year. While several pharmacological an...
Age: 18 - 85 years
Gender: All
Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure
CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the
effect of a customized, multifaceted, health system-level quality-improvement (QI) program
compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics.
Age: 18 years - 66+
Gender: All
Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction
Heart failure with preserved ejection fraction (HFPEF) is common and deadly but without
therapy. Inconclusive studies such as TOPCAT (Treatment of Preserved Cardiac Function Heart
Failure With an Aldosterone Antagonist) suggest spironolactone may be effective in HFP...
Age: 50 - 99 years
Gender: All
A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients
The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with
placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related
death post-hospital discharge in high-risk, medically ill patients.
Age: 40 years - 66+
Gender: All