Recruiting PHASE2 Sickle Cell Disease

New treatment option for Sickle Cell Disease

Official title Early Screening and Treatment of Heart Complication in Sickle Cell Disease

ClinicalTrials.gov ID: NCT07023666

What this study is testing

What is Deferoxamine?

Deferoxamine is an investigational medicine, being studied as a potential treatment for sickle cell disease.

Also referred to as Desferal.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study tests whether early heart screening and treatment for iron overload in subjects with sickle cell disease can prevent heart problems and reduce hospitalizations.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • At least 18 years of age
  • Diagnosis of sickle cell disease (any genotype)
  • Serum ferritin levels ≥ 400 ng/mL (up to 80 patients), or less than 400 ng/mL in those who have cardiac symptoms including shortness of breath and...
  • Willingness to undergo regular imaging (echocardiograms, ECG, cardiac MRI)
  • ECOG performance status of 0-1

You likely can't join if

  • Unable to schedule and required follow-up visits
  • Medical comorbidities including:
  • Known heart failure
  • Unstable angina
  • Uncontrolled dysrhythmias
  • Acute pulmonary embolism
See the full eligibility criteria
Who can join
  • At least 18 years of age
  • Diagnosis of sickle cell disease (any genotype)
  • Serum ferritin levels ≥ 400 ng/mL (up to 80 patients), or less than 400 ng/mL in those who have cardiac symptoms including shortness of breath and lower extremity edema (up to 20 patients)
  • Willingness to undergo regular imaging (echocardiograms, ECG, cardiac MRI)
  • ECOG performance status of 0-1
  • Able to read, understand and provide written informed consent
  • Deemed appropriate for participation by the treating physician
What rules you out
  • Unable to schedule and required follow-up visits
  • Medical comorbidities including:
  • Known heart failure
  • Unstable angina
  • Uncontrolled dysrhythmias
  • Acute pulmonary embolism
  • Active infection or severe comorbid conditions that in the view of the investigator would limit participation
  • History of hypersensitivity or contraindication to chelation therapy
  • Severe renal or hepatic impairment
  • Pregnancy of breastfeeding

The study team makes the final eligibility decision.

Where it's taking place

  • Fairfax, Virginia, United States
  • Falls Church, Virginia, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Fairfax, Virginia, United States; Falls Church, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.