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

February 12, 2024 updated by: Radha Gopalan

Effects of IV Iron Replacement on Exercise Capacity in Individuals With Heart Failure With Reduced Ejection Fraction and Iron Deficiency

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Currently 5.7 million people in the United States (US) have Heart Failure and it is expected that by 2030 more than 8 million people will have this condition, accounting for a 46 % increase in prevalence. Iron deficiency and anemia are both common findings in patients with heart failure and contribute to morbidity and mortality. The average cost of hospital admissions for heart failure are about $17,000-25,000; creating a large burden on health-care resources and iron replacement may serve to reduce readmissions at less than a tenth of the cost.

The working hypothesis to support Iron supplementation is that it improves oxygen carrying capacity, thereby improving exercise tolerance. Exercise tolerance in patients with heart failure is an important prognostic indicator.

Role of iron supplementation has been investigated to improve quality of life and outcomes in patients with heart failure and two large multi-centric trails. FAIR-HF and CONFIRM-HF have both showed significant improvement in symptoms and six-minute walk distances in patients with HFrEF after IV iron supplementation. This was found to be true for both anemic and non-anemic patients. Despite the current data, IV iron supplementation is currently only a class IIb recommendation for HFrEF and routine testing of iron studies, is not a part of practice guidelines for heart failure management.

Part of what makes the existing data less compelling is that exercise tolerance was assessed using a 6-minute walk test and though it correlates with functional capacity, it is a sub-maximal exercise test and cannot assess the peak oxygen uptake. Individuals with heart failure are often unable to attain this peak oxygen uptake. The inability to increase O2 uptake with exercise is what affects exercise capacity.

The study aims to bridge the gap between the response seen after IV iron supplementation and the change in physiology we attribute to it using a formal Cardiopulmonary exercise testing. A peak VO2 provides the most objective assessment of functional capacity in patients with HF. This parameter is a surrogate marker for the maximal cardiac output that an individual can achieve. A modest increase in peak VO2 of 6% at 3 months of exercise training has been associated with a reduction in mortality by 5 %.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner - University Medical Center, Phoenix campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IV Iron Infusion Group
Subjects will receive iron infusion 1 week after enrollment. Dosage of iron will be at discretion of physicians
Drug: IV Iron Infusion Group
Subjects will receive IV Iron Infusion. Dosage of iron will be at discretion of physicians
Other Names:
  • Ferric carboxymaltose injection
No Intervention: Control Group
Subjects will not receive iron replacement infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Capacity
Time Frame: 2 months after IV iron infusion
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
Time Frame: 2 months after IV iron infusion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Quality of Life measures
Time Frame: 2 months after IV iron infusion
A 6-minute walk test will be administered to determine if the NYHA class has improved.
2 months after IV iron infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radha Gopalan

Collaborators

American Regent, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001297

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only coded research data will be shared for data analysis by study team. Only limited data set may be shared with sponsor if requested according to data agreement. Future use data will be de-identified and stored in REDCap and only utilized by the investigator's department researchers. Publications and reports will be de-identified.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on IV Iron Infusion Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe