Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency
Status: | Recruiting |
---|---|
Conditions: | Cardiology, Anemia |
Therapuetic Areas: | Cardiology / Vascular Diseases, Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/16/2019 |
Start Date: | March 15, 2017 |
End Date: | June 2022 |
Contact: | James Marco |
Email: | HEART-FID@luitpold.com |
Phone: | 631-772-3504 |
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
The primary objective of this study is to determine the efficacy and safety of iron therapy
using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of
participants in heart failure with iron deficiency and with a reduced ejection fraction.
using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of
participants in heart failure with iron deficiency and with a reduced ejection fraction.
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 patients in heart failure with iron deficiency.
After 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.
Study drug administration will occur on Day 0 and Day 7 (±2) as an undiluted slow IV push,
with additional study visits planned at 3 month intervals, and additional dosing administered
every 6 months as applicable. In a subset of sites, all participants will return for
recurrent laboratory assessment (chemistry, hematology and iron indices) at Day 21 (± 7)
after each course of investigational treatment. For all participants, hematology, ferritin,
and transferrin saturation (TSAT), with appropriate safety evaluations, to determine
additional treatment, will occur at 6 month intervals.
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 patients in heart failure with iron deficiency.
After 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.
Study drug administration will occur on Day 0 and Day 7 (±2) as an undiluted slow IV push,
with additional study visits planned at 3 month intervals, and additional dosing administered
every 6 months as applicable. In a subset of sites, all participants will return for
recurrent laboratory assessment (chemistry, hematology and iron indices) at Day 21 (± 7)
after each course of investigational treatment. For all participants, hematology, ferritin,
and transferrin saturation (TSAT), with appropriate safety evaluations, to determine
additional treatment, will occur at 6 month intervals.
Inclusion Criteria:
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 4 weeks with no dose
changes in heart failure drugs during the last 2 weeks.
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 ≤35% obtained during the screening visit OR
either of the following i. Historical value of ejection fraction ≤35% within 12 months
of screening visit ii. Historical value of ejection fraction ≤25% within 24 months of
screening visit
5. Hemoglobin >9.0 g/dL and <13.5 g/dL (females) or <15.0 g/dL (males).
6. Serum ferritin <100 ng/mL or 100 to 300 ng/mL with TSAT <20%.
7. Either documented hospitalization for heart failure within 12 months of enrollment or
screening visit N-terminal-pro-brain natriuretic peptide (NT-proBNP) >600 pg/ml (or
BNP >200 pg/mL) for patients with normal sinus rhythm or NT-proBNP >1000 pg/ml (or BNP
>400 pg/mL) for patients with atrial fibrillation. NOTE: NT-proBNP must be used to
confirm eligibility for patients taking sacubitril/valsartan.
Exclusion Criteria:
1. Current or planned oral iron supplementation. Iron-containing multivitamins (<30 mgs
/day) are permitted.
2. Known hypersensitivity reaction to any component of FCM.
3. History of acquired iron overload, or the recent receipt (within 3 months) of
erythropoietin stimulating agent, IV iron therapy, or blood transfusion.
4. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or
stroke within 3 months of enrollment.
5. Uncorrected severe aortic stenosis, severe valvular regurgitation, or left ventricular
outflow obstruction requiring intervention.
6. Current atrial fibrillation or atrial flutter with a mean ventricular response rate
>100 per minute (at rest).
7. Current or planned mechanical circulatory support or heart transplantation.
8. Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
9. Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate
transaminase >3 times the upper limit of normal range).
10. Current or recent (within 3 years) malignancy with exception of basal cell carcinoma
or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
11. Known gastrointestinal bleeding. Patients with screening ferritin <15ng/ml must have
an appropriate evaluation within 3 months of screening.
12. 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.
13. Inability to return for follow up visits within the necessary windows
We found this trial at
167
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555 N Duke St
Lancaster, Pennsylvania 17602
Lancaster, Pennsylvania 17602
(717) 544-5511
![Lancaster General Hospital](/wp-content/uploads/logos/lancaster-general-hospital.png)
Principal Investigator: Lindsay Castle, DO
Phone: 717-544-1777
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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1029 West Meeting Street
Lancaster, South Carolina 29720
Lancaster, South Carolina 29720
Principal Investigator: Vipul Shah, MD
Phone: 803-285-2041
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Las Vegas, Nevada 89146
Principal Investigator: Lawrence Madoff, MD
Phone: 702-629-5311
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Lincoln, Nebraska 68526
Principal Investigator: Gina Mentzer, MD
Phone: 402-489-6555
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Little Rock, Arkansas 72211
Principal Investigator: Michael Huber, MD
Phone: 501-978-3703
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Littleton, Colorado 80120
Principal Investigator: Ira Dauber, MD
Phone: 303-703-2124
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Liverpool, New South Wales
Principal Investigator: Gayathri Kumarasinghe, MD
Phone: +61 2 8738 3998
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Long Beach, California 90806
Principal Investigator: Maleah Grover, MD
Phone: 562-988-7083
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Los Angeles, California 90036
Principal Investigator: Lydie Hazan, MD
Phone: 310-289-8242
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121 Gaslight Medical Parkway
Lufkin, Texas 75904
Lufkin, Texas 75904
Principal Investigator: Terry L Wells, MD
Phone: 936-634-0180
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Lynchburg, Virginia 24501
Principal Investigator: Brian Schietinger, MD
Phone: 434-200-2799
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Macon, Georgia 31201
Principal Investigator: Felix O Sogade, MD
Phone: 478-755-1560
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Marshfield, Wisconsin 54449
Principal Investigator: Kelley P Anderson, MD
Phone: 715-389-7543
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McKinney, Texas 75069
Principal Investigator: Venkata Chilakapati, MD
Phone: 972-562-2345
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4201 Medical Center Drive
McKinney, Texas 75701
McKinney, Texas 75701
Principal Investigator: Faizan Iftikhar, MD
Phone: 214-544-3355
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Miami, Florida 33155
Principal Investigator: Jesus Rodriguez de la Torre, MD
Phone: 786-631-3890
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Miami, Florida 33176
Principal Investigator: Antonio Blanco, MD
Phone: 786-636-6695
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Miami, Florida 33175
Principal Investigator: Sandor Romero, MD
Phone: 305-221-8001
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Miami, Florida 33165
Principal Investigator: Felix Chion-Fong, MD
Phone: 305-221-0660
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Miami Lakes, Florida
Principal Investigator: Javier Colomar, MD
Phone: 786-464-0012
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Minneapolis, Minnesota 55407
Principal Investigator: Peter Eckman, MD
Phone: 612-863-6286
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Minot, North Dakota 58701
Principal Investigator: Samir Turk, MD
Phone: 701-857-2510
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27700 Medical Center Road
Mission Viejo, California 92691
Mission Viejo, California 92691
Principal Investigator: Michael Miyamoto, MD
Phone: 949-364-3612
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Mobile, Alabama 36604
Principal Investigator: Frank M Lester, MD
Phone: 251-435-1210
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307 N University Blvd
Mobile, Alabama 36688
Mobile, Alabama 36688
(251) 460-6101
![University of South Alabama](/wp-content/uploads/logos/university-of-south-alabama.jpg)
Principal Investigator: Christopher Malozzi, DO
Phone: 251-471-7027
University of South Alabama "University of South Alabama is a public institution that was founded...
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602 South Sutherland Avenue
Monroe, North Carolina 28112
Monroe, North Carolina 28112
Principal Investigator: David Smith, MD
Phone: 704-283-7359
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Mooresville, North Carolina 28117
Principal Investigator: Elmer H Stout, MD
Phone: 704-360-9310
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Muncie, Indiana 47303
Principal Investigator: Wayne L Gray, MD
Phone: 765-281-2011
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