EUCTR2019-002912-25-LV进行中（未招募）1 期
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 - HEART-FID
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,014
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adult (=18 years of age) able to provide informed consent.
- •2. Stable heart failure (NYHA II-IV) on maximally-tolerated
- •background therapy (as determined by the site Principle
- •Investigator) for at least 2 weeks prior to randomization.
- •3. Able and willing to perform a 6MWT at the time of
- •randomization.
- •4. Reduced left ventricular ejection fraction. Assessment must be performed at least 12 weeks after major cardiac surgical
- •intervention including coronary artery bypass graft (CABG),valvular repair/replacement, or cardiac resynchronization therapy
- •(CRT) device implantation.
- •a. Left ventricular ejection fraction =40% obtained during
- •the screening visit OR either of the following
- •i. Historical value of ejection fraction =40% within 24 months of screening visit
- •ii. Historical value of ejection fraction =30% within 36 months of screening visit
- •5. Hemoglobin >9.0 g/dL and <13.5 g/dL (females) or <15.0 g/dL
- •(males) within 28 days of randomization.
- •6. Serum ferritin <100 ng/mL or 100 to 300 ng/mL with TSAT
- •<20%. Patients with screening ferritin <15 ng/mL must have
- •documentation of an appropriate evaluation, as determined by the
- •Principle Investigator, within 3 months of screening and prior to
- •randomization.
- •7. Either documented hospitalization for heart failure within 12
- •months of enrollment or elevated N-terminal-pro-brain natriuretic
- •peptide (NT-proBNP) within 90 days of randomization:
- •a. For patients in normal sinus rhythm: N-terminal-pro-brain
- •natriuretic peptide (NT-proBNP) >600 pg/mL (or BNP
- •>200 pg/mL)
- •b. For patients in atrial fibrillation: NT-proBNP >1000
- •pg/mL (or BNP >400 pg/mL
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1508
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1508
排除标准
- •1. Known hypersensitivity reaction to any component of FCM.
- •2. History of acquired iron overload, or the recent receipt (within
- •3 months) of erythropoietin stimulating agent, IV iron therapy,
- •or blood transfusion.
- •3. Acute myocardial infarction, acute coronary syndrome,
- •transient ischemic attack, or stroke within 30 days of enrollment.
- •4. Uncorrected severe aortic stenosis, severe valvular regurgitation, or left ventricular outflow obstruction requiring intervention.
- •5. Current atrial fibrillation or atrial flutter with a mean ventricular response rate >100 per minute (at rest).
- •6. Current or planned mechanical circulatory support or heart
- •transplantation.
- •7. Hemodialysis or peritoneal dialysis (current or planned within
- •the next 6 months).
- •8. Documented liver disease, or active hepatitis (i.e. alanine
- •transaminase or aspartate transaminase >3 times the upper limit of normal range).
- •9. Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
研究者
相似试验
进行中（未招募）
1 期
This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD)Subjects with moderately to severely active Crohn's diseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2021-002869-18-BEAbbVie Deutschland GmbH & Co. KG265
进行中（未招募）
1 期
Clinical Trial to compare if seriously-ill adults with constipation due to narcotics have bowel movements sooner after injection with Methylnatrexone or placeboEUCTR2007-000854-30-BESalix Pharmaceuticals Inc254
进行中（未招募）
不适用
A study to evaluate the effect and safety of a 4 week treatment plan of Alirocumab in patients with high cholesterolPrimary HypercholesterolemiaMedDRA version: 17.0Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 100000004861EUCTR2013-002343-29-GBRegeneron Pharmaceuticals, Inc.803
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Markers of Intravascular Inflammation in Subjects with Coronary Artery Disease - E5555-G000-201Coronary Artery DiseaseMedDRA version: 8.1Level: PTClassification code 10011078EUCTR2005-006029-94-BEEisai Limited720
已完成
不适用
A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Male Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of JNJ-26070109abdominal pain and heartburn10017943NL-OMON30044Janssen-Cilag82