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NCT00068159 · ClinicalTrials.gov registry record
Cardiac Function in Patients With Hereditary Hemochromatosis
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 70
- Enrollment target
NCT00068159: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00068159 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 70 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00068159 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 70 participants
- Enrollment target
Study Summary
This study will examine the effect of iron buildup in the hearts of patients with hereditary hemochromatosis (HH), a genetic disease that causes the body to accumulate excess amounts of iron. The excess iron can damage the heart, liver, pancreas, skin, and joints. Generally, early treatment with phlebotomy (periodic removal of a unit of blood), and in some cases chelation (using a drug to remove iron from the body) slows down organ damage in HH patients. This study will try to elucidate the effect of iron buildup in the heart and determine if phlebotomy and chelation help keep the heart healthy. Patients with HH and healthy volunteers 21 years of age and older may be eligible for this study. (Normal volunteers will provide normal values of heart function that will be used to verify abnormalities detected in HH patients.) Patients must have a gene abnormality of Hfe gene Cys282Try homozygote. They may or may not be receiving treatment for HH and they must have no heart symptoms or serious organ damage due to HH. Candidates will be screened with a medical history and physical examination, blood tests, electrocardiogram (EKG), Holter EKG (24-hour EKG monitoring, see description below), and chest x-ray. Participants will undergo the following tests and procedures over 2 to 5 days: * Exercise test: The participant exercises on a treadmill while wearing a mouthpiece, which is used to measure how much oxygen is used. Electrodes placed on the chest and arms monitor the heartbeat during the test. * Echocardiography: This ultrasound test uses sound waves to take pictures. A small probe is held against the chest to allow a technician to take pictures of the heart and assess its function. A drug called Optison may be injected in an arm vein if needed to enhance the ultrasound images. * Exercise stress echocardiography: The participant exercises on a stationary bike while heart function is measured with an echocardiogram, EKG, and blood pressure cuff. * 24-hour Holter EKG: Th
Primary Outcome
To assess detailed cardiac function using non-invasive cardiac imaging in Group A; untreated-NYHA Class I HH subjects without conventional therapy for HH, Group B; treated- NYHA Class I HH subjects with conventional phlebotomy and/or iron chelation therapy and compare these results to those from Group C; age-gender matched healthy control volunteers.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2003-12-08 |
| Est. Completion | 2022-07-06 |
What the finished NCT00068159 record still lists
NCT00068159 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 70 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00068159 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00068159 about?
NCT00068159 is a clinical study titled "Cardiac Function in Patients With Hereditary Hemochromatosis". This study will examine the effect of iron buildup in the hearts of patients with hereditary hemochromatosis (HH), a genetic disease that causes the body to accumulate excess amounts of iron. The excess iron can damage the heart, liver, pancreas, skin, and joints. Generally, early treatment with phl...
What is the current status of trial NCT00068159?
This trial is currently completed. The enrollment target is 70 participants. The study started on 2003-12-08. Estimated completion is 2022-07-06.
Who is sponsoring clinical trial NCT00068159?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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