Effects of IV Iron Replacement on Exercise Capacity in Individuals With Heart Failure

NCT05816265 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: STUDY00001297
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with heart failure with reduced ejection fraction and iron deficiency will be randomized to either receive iron infusion or be in the control group. The study is looking at how iron replacement affects exercise capacity as measured by peak oxygen uptake.

Conditions

Heart Failure; Iron-deficiency

Keywords

Reduced ejection fraction; Exercise; iron supplementation; Cardiopulmonary exercise; peak oxygen uptake

Outcome Measures

Primary Outcomes (2)

• Exercise Capacity

  Cardiopulmonary exercise testing will be administered to measure Peak V02. During the exercise testing a special mouthpiece that can measure oxygen and carbon dioxide is used to measure peak oxygen uptake.

  2 months after IV iron infusion

• Patient subjective outcome measures

  Subjects will complete the Kansas City Cardiomyopathy Questionnaire.The lowest score is 0 and the highest score is 100. The higher the score is, the better the quality of life.

  2 months after IV iron infusion

Secondary Outcomes (1)

• Objective Quality of Life measures

  2 months after IV iron infusion

Study Arms (2)

IV Iron Infusion Group

EXPERIMENTAL

Subjects will receive iron infusion 1 week after enrollment. Dosage of iron will be at discretion of physicians

Drug: IV Iron Infusion Group

Control Group

NO INTERVENTION

Subjects will not receive iron replacement infusion.

Interventions

IV Iron Infusion Group DRUG

Subjects will receive IV Iron Infusion. Dosage of iron will be at discretion of physicians

Also known as: Ferric carboxymaltose injection

IV Iron Infusion Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-90 years
• New York Heart Association Class II-III heart failure
• Left ventricular dysfunction with left ventricular ejection fraction ≤ 40%
• Ferritin \< 100 ng/mL or 100-300 ng/mL with transferrin saturation (TSAT) \< 20%
• Patients deemed by an attending physician to require intravenous iron therapy
• The patient is willing and able to comply with the protocol and has provided written informed consent

You may not qualify if:

• Iron overload disorders or allergy, concomitant nutritional deficiencies- B12 and folate
• Recent Acute Coronary Syndrome
• Physical barriers to exercise capacity
• Currently presenting in heart failure exacerbation
• Declined participation
• Chronic liver disease
• NYHA class IV
• Active bleeding
• Pregnancy
• Life expectancy ≤ 12 months

Sponsors & Collaborators

• Radha Gopalan: lead
• American Regent, Inc.: collaborator

Study Sites (1)

Banner - University Medical Center, Phoenix campus

Phoenix, Arizona, 85006, United States

Location

Related Publications (11)

• Jankowska EA, Rozentryt P, Witkowska A, Nowak J, Hartmann O, Ponikowska B, Borodulin-Nadzieja L, Banasiak W, Polonski L, Filippatos G, McMurray JJ, Anker SD, Ponikowski P. Iron deficiency: an ominous sign in patients with systolic chronic heart failure. Eur Heart J. 2010 Aug;31(15):1872-80. doi: 10.1093/eurheartj/ehq158. Epub 2010 Jun 21.

  PMID: 20570952 BACKGROUND

• von Haehling S, Ebner N, Evertz R, Ponikowski P, Anker SD. Iron Deficiency in Heart Failure: An Overview. JACC Heart Fail. 2019 Jan;7(1):36-46. doi: 10.1016/j.jchf.2018.07.015. Epub 2018 Dec 12.

  PMID: 30553903 BACKGROUND

• Ebner N, von Haehling S. Iron deficiency in heart failure: a practical guide. Nutrients. 2013 Sep 23;5(9):3730-9. doi: 10.3390/nu5093730.

  PMID: 24064572 BACKGROUND

• Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart Rothe B, Pocock SJ, Poole-Wilson PA, Ponikowski P; FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.

  PMID: 19920054 BACKGROUND

• Ezekowitz JA, McAlister FA, Armstrong PW. Anemia is common in heart failure and is associated with poor outcomes: insights from a cohort of 12 065 patients with new-onset heart failure. Circulation. 2003 Jan 21;107(2):223-5. doi: 10.1161/01.cir.0000052622.51963.fc.

  PMID: 12538418 BACKGROUND

• Klip IT, Comin-Colet J, Voors AA, Ponikowski P, Enjuanes C, Banasiak W, Lok DJ, Rosentryt P, Torrens A, Polonski L, van Veldhuisen DJ, van der Meer P, Jankowska EA. Iron deficiency in chronic heart failure: an international pooled analysis. Am Heart J. 2013 Apr;165(4):575-582.e3. doi: 10.1016/j.ahj.2013.01.017. Epub 2013 Feb 22.

  PMID: 23537975 BACKGROUND

• Okonko DO, Mandal AK, Missouris CG, Poole-Wilson PA. Disordered iron homeostasis in chronic heart failure: prevalence, predictors, and relation to anemia, exercise capacity, and survival. J Am Coll Cardiol. 2011 Sep 13;58(12):1241-51. doi: 10.1016/j.jacc.2011.04.040.

  PMID: 21903058 BACKGROUND

• Lim EA, Sohn HS, Lee H, Choi SE. Cost-utility of ferric carboxymaltose (Ferinject(R)) for iron-deficiency anemia patients with chronic heart failure in South Korea. Cost Eff Resour Alloc. 2014 Sep 10;12:19. doi: 10.1186/1478-7547-12-19. eCollection 2014.

  PMID: 25278814 BACKGROUND

• Wang G, Zhang Z, Ayala C, Wall HK, Fang J. Costs of heart failure-related hospitalizations in patients aged 18 to 64 years. Am J Manag Care. 2010 Oct;16(10):769-76.

  PMID: 20964473 BACKGROUND

• Fang J, Mensah GA, Croft JB, Keenan NL. Heart failure-related hospitalization in the U.S., 1979 to 2004. J Am Coll Cardiol. 2008 Aug 5;52(6):428-34. doi: 10.1016/j.jacc.2008.03.061.

  PMID: 18672162 BACKGROUND

• Swank AM, Horton J, Fleg JL, Fonarow GC, Keteyian S, Goldberg L, Wolfel G, Handberg EM, Bensimhon D, Illiou MC, Vest M, Ewald G, Blackburn G, Leifer E, Cooper L, Kraus WE; HF-ACTION Investigators. Modest increase in peak VO2 is related to better clinical outcomes in chronic heart failure patients: results from heart failure and a controlled trial to investigate outcomes of exercise training. Circ Heart Fail. 2012 Sep 1;5(5):579-85. doi: 10.1161/CIRCHEARTFAILURE.111.965186. Epub 2012 Jul 6.

  PMID: 22773109 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Anemia, Iron-Deficiency; Motor Activity

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor of Medicine and Cardiology

Model Details: Randomization will be 1:1 between control group and iron group. Subjects randomized to the iron group will receive iron infusion 1 week after enrollment. The control group will not receive iron replacement infusion.

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 18, 2023
• Study Start: January 24, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)