Heart Failure
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CLINICAL_TRIALS trial_result · 2023-10-02Clinical Trial Update: Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry
A completed clinical trial registry update evaluating strategies to optimize response to cardiac resynchronization therapy in heart failure …
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CLINICAL_TRIALS trial_result · 2023-09-29Clinical Trial Update: Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors [Phase 2]
A Phase 2 trial evaluating carvedilol to prevent heart failure in childhood cancer survivors has completed and results have been posted.
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FDA approval · 2023-09-26FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)
The FDA approved a supplemental application for metoprolol succinate from Nivagen Pharmaceuticals, Inc., authorizing changes to the product'…
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CLINICAL_TRIALS trial_result · 2023-09-26Clinical Trial Update: The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life [Phase 4]
Phase 4 trial evaluating ferric derisomaltose for improving exercise capacity and quality of life in patients with acute heart failure and i…
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FDA approval · 2023-09-12FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for metoprolol succinate from Mylan Pharmaceuticals Inc.
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CLINICAL_TRIALS trial_result · 2023-09-11Clinical Trial Update: Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency [Phase 3]
Phase 3 clinical trial update assessing safety and tolerability of intravenous tonapofylline in subjects with acute decompensated heart fail…
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FDA approval · 2023-09-11FDA Approved: ACETAZOLAMIDE — Original Application (Ajanta Pharma USA Inc.)
FDA approved Ajanta Pharma USA Inc.'s original application for acetazolamide (generic).
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FDA approval · 2023-09-08FDA Approved: DOBUTAMINE HYDROCHLORIDE IN DEXTROSE — Supplemental Application (Baxter Healthcare Corporation)
FDA approved a supplemental application for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (Baxter).
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FDA approval · 2023-09-05FDA Approved: SPIRONOLACTONE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved the original ANDA for spironolactone from Amneal Pharmaceuticals NY LLC, enabling a generic version of the diuretic.
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FDA approval · 2023-08-24FDA Approved: SPIRONOLACTONE — Supplemental Application (Padagis US LLC)
FDA approved a supplemental application for spironolactone from Padagis US LLC, indicating an updated regulatory action on this product (sup…
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CLINICAL_TRIALS trial_result · 2023-08-24Clinical Trial Update: C-Pulse IDE Feasibility Study- A Heart Assist System [NA]
Feasibility study results for the C-Pulse heart assist system in heart failure are completed with results posted.
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CLINICAL_TRIALS trial_result · 2023-08-22Clinical Trial Update: Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure [Phase 2]
Phase 2 clinical trial update evaluating short-term Copaxone therapy for anti-inflammatory effects in acute decompensated heart failure.
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CLINICAL_TRIALS trial_result · 2023-08-21Clinical Trial Update: Effects of Remote Patient Monitoring on Chronic Disease Management [NA]
Completed clinical trial examining the impact of remote patient monitoring on management of chronic diseases with results posted in 2023.
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CLINICAL_TRIALS trial_result · 2023-08-15Clinical Trial Update: The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF) [Phase 4]
A Phase 4 clinical trial evaluating ferric derisomaltose for improving exercise capacity and quality of life in patients with acute heart fa…
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CLINICAL_TRIALS trial_result · 2023-08-08Clinical Trial Update: C-Pulse® System European Multicenter Study
Multicenter European study for the C-Pulse System in heart failure has completed and results were posted in 2023.
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FDA approval · 2023-08-07FDA Approved: METOPROLOL SUCCINATE — Original Application (Granules India Ltd)
FDA approved METOPROLOL SUCCINATE (extended-release) as an original generic application from Granules India Ltd, enabling its marketing for …
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CLINICAL_TRIALS trial_result · 2023-08-04Clinical Trial Update: Effect of Dapagliflozin in Patients With Acute Heart Failure (DAPA-RESPONSE-AHF) [Phase 2, Phase 3]
Phase 2/3 trial update investigating dapagliflozin for acute heart failure has completed.
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CLINICAL_TRIALS trial_result · 2023-08-01Clinical Trial Update: The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea [Phase 3]
Phase 3 trial assessing low flow nocturnal oxygen therapy in patients with heart failure and central sleep apnea was terminated; results pos…
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CLINICAL_TRIALS trial_result · 2023-08-01Clinical Trial Update: Efficacy of Oral Acetazolamide in Decongestion in Patients With Heart Failure [Phase 3]
A Phase 3 clinical trial update evaluating the efficacy of oral acetazolamide for decongestion in patients with heart failure. Status is cur…
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CLINICAL_TRIALS trial_result · 2023-08-01Clinical Trial Update: Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study [Phase 2]
A Phase 2 pilot study evaluating furoscix for avoiding hospitalization in heart failure patients with congestion has completed with results …
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CLINICAL_TRIALS trial_result · 2023-08-01Clinical Trial Update: Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION [NA]
A completed clinical trial evaluating remote monitored exercise testing for improving outcomes in heart failure, with results posted in 2023…
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CLINICAL_TRIALS trial_result · 2023-07-28Clinical Trial Update: Management of Volume Overload HF Patients by Individual DSR Treatment adJustment-a clinicAl inVestigation of InfusatE2.0 [Phase 1, Phase 2]
A clinical trial update for InfusatE2.0 investigating individual device-based adjustments to manage volume overload in heart failure patient…
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CLINICAL_TRIALS trial_result · 2023-07-27Clinical Trial Update: A Study of Prolonged Electrocardiographic Monitoring in Patients With Heart Failure in Sinus Rhythm or Atrial Fibrillation
A completed clinical trial evaluating prolonged electrocardiographic monitoring in patients with heart failure in sinus rhythm or atrial fib…
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FDA approval · 2023-07-26FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC.
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FDA approval · 2023-07-24FDA Approved: BUMETANIDE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' original ANDA for bumetanide, a loop diuretic used to treat edema and related conditions.