buglooki.blogg.se - Type to learn 4 trial

#TYPE TO LEARN 4 TRIAL WINDOWS#

Jonesboro, Arkansas, United States, 72401 No participants with Current COVID-19 Infection into the study.Īlexander City, Alabama, United States, 35010Ĭottonwood, Arizona, United States, 86326Ĭlinical Research Institute of Arizona, LLCĬarondelet Heart and Vascular Institute - Cardiology Eastįort Smith, Arkansas, United States, 72901.

Concurrently in a study with investigational product.

#TYPE TO LEARN 4 TRIAL WINDOWS#

Inability to return for follow up visits within the necessary windows.

Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.

Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.

alanine transaminase or aspartate transaminase >3 times the upper limit of normal range).

Documented liver disease, or active hepatitis (i.e.

Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).

Current or planned mechanical circulatory support or heart transplantation.

Current atrial fibrillation or atrial flutter with a mean ventricular response rate >100 per minute (at rest).

Uncorrected severe aortic stenosis, severe valvular regurgitation (except mitral regurgitation due to left ventricular dilatation without planned intervention), or left ventricular outflow obstruction requiring intervention.

Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 30 days of enrollment.

History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, IV iron therapy, or blood transfusion.

Known hypersensitivity reaction to any component of FCM.

For patients in atrial fibrillation: NT-proBNP >1000 pg/mL (or BNP >400 pg/mL).

Hemoglobin >9.0 g/dL and 600 pg/mL (or BNP >200 pg/mL).

Historical value of ejection fraction ≤ 30% within 36 months of screening visit Historical value of ejection fraction ≤ 40% within 24 months of screening visit ii. Left ventricular ejection fraction ≤ 40% obtained during the screening visit OR either of the following i.

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.Ī. Reduced left ventricular ejection fraction. Able and willing to perform a 6MWT at the time of randomization.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.Adult (≥18 years of age) able to provide signed, written informed consent.For all participants, hematology, ferritin, and transferrin saturation (TSAT), with appropriate safety evaluations, to determine additional treatment, will occur at 6 month intervals. In a subset of sites, a sub-study will be conducted to characterize serum phosphate levels over time in participants with heart failure and iron deficiency after dosing with FCM. Study drug administration will occur on Day 0 and Day 7 (☒) as an undiluted slow IV push, with additional study visits planned at 3 month intervals, and additional dosing administered every 6 months as applicable. 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) distance for patients in heart failure with iron deficiency.Īfter an initial screening period of up to 28 days, eligible participants will be stratified by region and randomized in a 1:1 ratio to FCM or placebo for treatment. Why Should I Register and Submit Results?.