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Iron Replacement
IV Iron Replacement for Heart Failure
Phase 4
Waitlist Available
Research Sponsored by Radha Gopalan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-90 years
New York Heart Association Class II-III heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months after iv iron infusion
Awards & highlights
Study Summary
This trial investigates how iron replacement can improve exercise capacity in heart failure patients with iron deficiency.
Who is the study for?
This trial is for adults aged 18-90 with heart failure who have iron deficiency (ferritin <100 ng/mL or ferritin 100-300 ng/mL with TSAT <20%) and reduced heart function (ejection fraction ≤40%). They should be able to exercise and follow the study plan. Excluded are those with severe heart failure, active bleeding, recent heart issues, pregnancy, short life expectancy, certain deficiencies or allergies.Check my eligibility
What is being tested?
The trial is testing if IV iron infusions can improve exercise capacity in patients with a specific type of heart failure and iron deficiency. Participants will either receive the iron infusion or be placed in a control group without it. The main measure of success is an increase in peak oxygen uptake during exercise.See study design
What are the potential side effects?
Potential side effects from IV iron infusions include allergic reactions, low blood pressure during infusion, muscle cramps, nausea, joint pain, dizziness or fainting. However not everyone experiences these side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 90 years old.
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I have moderate heart failure.
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My heart's left ventricle is not pumping well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months after iv iron infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months after iv iron infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Exercise Capacity
Patient subjective outcome measures
Secondary outcome measures
Objective Quality of Life measures
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IV Iron Infusion GroupExperimental Treatment1 Intervention
Subjects will receive iron infusion 1 week after enrollment. Dosage of iron will be at discretion of physicians
Group II: Control GroupActive Control1 Intervention
Subjects will not receive iron replacement infusion.
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Who is running the clinical trial?
Radha GopalanLead Sponsor
American Regent, Inc.Industry Sponsor
60 Previous Clinical Trials
19,075 Total Patients Enrolled
1 Trials studying Heart Failure
3,065 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have iron overload, allergies to it, or lack of B12 and folate.I am between 18 and 90 years old.I recently had a heart attack or related condition.I have moderate heart failure.Your ferritin levels are less than 100 ng/mL or between 100-300 ng/mL with low transferrin saturation.My heart condition severely limits my physical activity.I am currently experiencing a worsening of my heart failure.I am currently experiencing active bleeding.You are expected to live for less than 12 months.I have a long-term liver condition.My doctor says I need iron treatment through an IV.You have physical limitations that affect your ability to exercise.I have chosen not to participate in this trial.My heart's left ventricle is not pumping well.
Research Study Groups:
This trial has the following groups:- Group 1: IV Iron Infusion Group
- Group 2: Control Group
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elucidate the extent of risk associated with IV Iron Infusion Group?
"The IV Iron Infusion Group has been approved for medical use, thus it earned a safety rating of 3."
Answered by AI
Is recruitment still underway for this research endeavor?
"Clinicaltrials.gov confirms that this particular study, which was uploaded on June 1st 2023 and last updated April 14th of the same year, is no longer recruiting participants. Luckily, there are still 780 other trials presently enrolling patients."
Answered by AI
Is there an age restriction for participants of this clinical trial?
"To join this scientific experiment, patients must be aged between 18-90 years old. 38 studies are open to minors and 740 for elderly individuals."
Answered by AI
Who meets the criteria to take part in this medical research?
"To be admitted to the study, individuals must have heart failure and lie between 18-90 years old. The total number of participants is limited to 40."
Answered by AI
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