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RecruitingPhase 2

Early Screening and Treatment of Heart Complication in Sickle Cell Disease

Early Detection and Management of Cardiac Iron Overload in Sickle Cell Disease Using Multimodal Imaging for Improved Clinical Outcomes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The goal of the study is to detect iron-related heart problems in subjects with sickle cell disease (SCD) through regular cardiac imaging (electrocardiogram, echocardiogram, cardiac MRI) and lab testing every 3 months during the 12 months period."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether early heart checks and treatment for too much iron can prevent heart problems and reduce hospital stays. It is for adults with sickle cell disease who have high iron levels or heart symptoms.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • You have any type of sickle cell disease.
  • Your ferritin level, a blood measure of stored iron, is at least 400 ng/mL. If it is lower, you must have heart symptoms, such as shortness of breath or swelling in your legs.
  • You agree to regular heart tests: ultrasound pictures (echocardiograms), electrical tests (ECGs), and MRI scans.
  • You can do all usual activities, or only have limits on hard physical activity (ECOG score 0–1).
  • You can read and understand the study information and sign a form agreeing to join.
  • Your treating doctor thinks the study is right for you.

Who can't join

  • You cannot schedule or attend required follow-up visits.
  • You have known heart failure, meaning your heart does not pump as well as it should.
  • You have unstable angina (new or worsening chest pain) or an uncontrolled abnormal heartbeat.
  • You have an acute pulmonary embolism (a sudden blood clot in the lungs).
  • You have an active infection or another serious illness that the study doctor thinks would limit your participation.
  • You have had an allergic reaction to iron-removal treatment (chelation), or there is a medical reason you cannot receive it.
  • You have severe kidney or liver problems.
  • You are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study sites (2)

VA