Purpose of this Study
In this study, people will be placed into one of two groups by chance. One group will receive a one time treatment of iron given through a vein. The other group will receive a placebo, which is a salt water infusion with no medicine. Participants will not know which treatment they receive.
The first visit will be in person and may take a few hours. After that, most follow up visits will be done from home by phone or video. The study lasts about six months, and there will be a final in person visit at the end.
Who Can Participate?
Eligibility
People can join this study if they are 65 years old or older and have a type of heart failure called HFpEF, which means the heart pumps well but does not relax and fill properly. They must also have low iron levels shown by a blood test and be able to walk on their own. They must have been in the hospital for heart failure within the past year.
People cannot join if they have certain safety concerns related to iron, serious kidney problems, or have recently received iron through a vein. They also cannot be in another research study at the same time or have other causes of heart problems, such as severe valve disease or problems with the lining around the heart.
Age Range
65-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is looking at whether giving iron through a vein can help people who have heart failure where the heart still pumps well but does not relax properly. These people also have low iron levels. Researchers want to see if this treatment is safe and if it can help improve health and symptoms. The goal is to learn if this type of iron treatment can help people feel better and have better heart health compared to not receiving iron.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Iron Needed for Function and Undesirable Symptoms in Elderly with Heart Failure with Preserved Ejection Fraction - sIRB
Principal Investigator
Marat
Fudim
Protocol Number
PRO00119548
Phase
IV
Enrollment Status
Pending Open to Enrollment