Sickle Cell DiseasePhase 2NCT07023666
Early Screening and Treatment of Heart Complication in Sickle Cell Disease
A Phase 2 study testing Deferoxamine, Deferasirox and Deferiprone in people with Sickle Cell Disease, run by Inova Health Care Services at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Deferoxamine, Deferasirox and Deferiprone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Oct 2025to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
Who cannot join
- Unable to schedule and required follow-up visits
- Medical comorbidities including:
- Known heart failure
- Unstable angina
- Uncontrolled dysrhythmias
- Acute pulmonary embolism
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Inova Schar Cancer
Fairfax, Virginia, 22031
Keary Jane't, 571-472-3173, keary.janet@inova.org
Sheinei Alan, MD
- Recruiting
Inova Health Care Service
Falls Church, Virginia, 22042
Keary Jane't, 571-472-3173, keary.janet@inova.org
Elahe Mollapour, 571-472-0615, elahe.mollapour@inova.org
About this study
Official title: Early Detection and Management of Cardiac Iron Overload in Sickle Cell Disease Using Multimodal Imaging for Improved Clinical Outcomes
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.
Read the detailed description
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. The treatment will be with iron chelation and guideline-directed heart medications.
- Conditions
- Sickle Cell Disease
- Being tested
- Deferoxamine, Deferasirox, Deferiprone, Echocardiography, Electrocardiogram (ECG)
- Keywords
- Iron Overload, Cardiomyopathies, Arrhythmias
- Medical subject headings
- Anemia, Sickle Cell, Iron Overload, Cardiomyopathies, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeferoxamineDrug
Also called Desferal
Deferoxamine is used to reduce excess iron accumulation after monitoring iron levels. Adjustment to therapy will be based on iron burden assessments throughout the study duration.
DeferasiroxDrug
Also called Jadenu, Exjade
Deferasirox is used for iron chelation therapy based on iron burden assessment throughout the study.
DeferiproneDrug
Also called Ferriprox
Deferiprone is used for iron chelation therapy used throughout the study.
EchocardiographyDevice
This device uses ultrasound waves to create images of heart to help evaluate the heart's structure and function. This allows the detection of abnormalities of heart due to iron overload through out the study.
Electrocardiogram (ECG)Device
The Electrocardiogram (ECG) device records the electrical activity of the heart. It is crucial for identifying arrhythmias and conduction abnormalities, which can be exacerbated by iron accumulation in the heart.
| Study group | Role | What they receive |
|---|---|---|
| Intervention for Cardiac Iron Overload in Sickle Cell Patients | Experimental | The study intervention consists of regular cardiac monitoring, iron chelation therapy and guideline-directed medical therapy (GDMT). Receives: Drug: Deferoxamine; Drug: Deferasirox; Drug: Deferiprone; Device: Echocardiography; Device: Electrocardiogram (ECG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hospitalization for Sickle Cell Disease Related Complications
Total number of participants hospitalized for SCD related complications including vaso-occlusive crises, acute chest syndrome and infection detect the impact of early intervention of cardiac iron overload in patients with Sickle Cell Disease
Measured: Up to 12 months
Length of Stay for SCD-Related Complications
The total number of days spent in the hospital per admission for complications related to SCD.
Measured: Up to 12 Months
Secondary outcomes (2)
Incidence of Left and/or Right Heart Failure
Total number of participants who develop left and/or right heart failure is estimated using descriptive statistics with 95% confidence intervals.
Measured: Up to 12 Months
Incidence of Atrial or Ventricular Arrhythmia or Conduction Abnormalities
The number of participants with conditions such as atrial fibrillation, ventricular tachycardia, or conduction system disease. Reported with 95% confidence intervals.
Measured: Up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start7 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheinei Alan, MD, Principal investigator, Inova Fairfax Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023666
- Sponsor's protocol ID
- INOVA-2023-159
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Fitzhugh CD, Lauder N, Jonassaint JC, Telen MJ, Zhao X, Wright EC, Gilliam FR, De Castro LM. Cardiopulmonary complications leading to premature deaths in adult patients with sickle cell disease. Am J Hematol. 2010 Jan;85(1):36-40. doi: 10.1002/ajh.21569.
PubMed 20029950Hamideh D, Alvarez O. Sickle cell disease related mortality in the United States (1999-2009). Pediatr Blood Cancer. 2013 Sep;60(9):1482-6. doi: 10.1002/pbc.24557. Epub 2013 Apr 23.
PubMed 23637037Lanzkron S, Carroll CP, Haywood C Jr. Mortality rates and age at death from sickle cell disease: U.S., 1979-2005. Public Health Rep. 2013 Mar-Apr;128(2):110-6. doi: 10.1177/003335491312800206.
PubMed 23450875Whipple NS, Naik RJ, Kang G, Moen J, Govindaswamy SD, Fowler JA, Dowdy J, Penkert R, Joshi VM, Hankins JS. Ventricular global longitudinal strain is altered in children with sickle cell disease. Br J Haematol. 2018 Dec;183(5):796-806. doi: 10.1111/bjh.15607. Epub 2018 Nov 19.
PubMed 30450553Darbari DS, Sheehan VA, Ballas SK. The vaso-occlusive pain crisis in sickle cell disease: Definition, pathophysiology, and management. Eur J Haematol. 2020 Sep;105(3):237-246. doi: 10.1111/ejh.13430. Epub 2020 May 19.
PubMed 32301178Modell CB. Haemoglobinopathies. The pathophysiology of beta-thalassaemia major. J Clin Pathol Suppl (R Coll Pathol). 1974;8:12-8. No abstract available.
PubMed 4536357Taher AT, Saliba AN. Iron overload in thalassemia: different organs at different rates. Hematology Am Soc Hematol Educ Program. 2017 Dec 8;2017(1):265-271. doi: 10.1182/asheducation-2017.1.265.
PubMed 29222265
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Management of Cardiac Iron Overload in Sickle Cell Disease Using Multimodal Imaging for Improved Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07023666
- Acronym / sponsor ID
- INOVA-2023-159
- Conditions
- Sickle Cell Disease
- Keywords
- Iron Overload, Cardiomyopathies, Arrhythmias
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The treatment will be with iron chelation and guideline-directed heart medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention for Cardiac Iron Overload in Sickle Cell Patients | Experimental | Drug: Deferoxamine, Drug: Deferasirox, Drug: Deferiprone, Device: Echocardiography, Device: Electrocardiogram (ECG)The study intervention consists of regular cardiac monitoring, iron chelation therapy and guideline-directed medical therapy (GDMT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Unable to schedule and required follow-up visits
- Medical comorbidities including:
- Known heart failure
- Unstable angina
- Uncontrolled dysrhythmias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeferoxamineAlso: DesferalDeferoxamine is used to reduce excess iron accumulation after monitoring iron levels. Adjustment to therapy will be based on iron burden assessments throughout the study duration. | Drug | Intervention for Cardiac Iron Overload in Sickle Cell Patients |
| DeferasiroxAlso: Jadenu, ExjadeDeferasirox is used for iron chelation therapy based on iron burden assessment throughout the study. | Drug | Intervention for Cardiac Iron Overload in Sickle Cell Patients |
| DeferiproneAlso: FerriproxDeferiprone is used for iron chelation therapy used throughout the study. | Drug | Intervention for Cardiac Iron Overload in Sickle Cell Patients |
| EchocardiographyThis device uses ultrasound waves to create images of heart to help evaluate the heart's structure and function. This allows the detection of abnormalities of heart due to iron overload through out the study. | Device | Intervention for Cardiac Iron Overload in Sickle Cell Patients |
| Electrocardiogram (ECG)The Electrocardiogram (ECG) device records the electrical activity of the heart. It is crucial for identifying arrhythmias and conduction abnormalities, which can be exacerbated by iron accumulation in the heart. | Device | Intervention for Cardiac Iron Overload in Sickle Cell Patients |
Primary outcome
Incidence of Hospitalization for Sickle Cell Disease Related Complications
Time frame: Up to 12 months
Total number of participants hospitalized for SCD related complications including vaso-occlusive crises, acute chest syndrome and infection detect the impact of early intervention of cardiac iron overload in patients with Sickle Cell Disease
Length of Stay for SCD-Related Complications
Time frame: Up to 12 Months
The total number of days spent in the hospital per admission for complications related to SCD.
2 secondary outcomes
Incidence of Left and/or Right Heart Failure
Time frame: Up to 12 Months
Incidence of Atrial or Ventricular Arrhythmia or Conduction Abnormalities
Time frame: Up to 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 20029950Fitzhugh CD, Lauder N, Jonassaint JC, Telen MJ, Zhao X, Wright EC, Gilliam FR, De Castro LM. Cardiopulmonary complications leading to premature deaths in adult patients with sickle cell disease. Am J Hematol. 2010 Jan;85(1):36-40. doi: 10.1002/ajh.21569.
- Background: PubMed 23637037Hamideh D, Alvarez O. Sickle cell disease related mortality in the United States (1999-2009). Pediatr Blood Cancer. 2013 Sep;60(9):1482-6. doi: 10.1002/pbc.24557. Epub 2013 Apr 23.
- Background: PubMed 23450875Lanzkron S, Carroll CP, Haywood C Jr. Mortality rates and age at death from sickle cell disease: U.S., 1979-2005. Public Health Rep. 2013 Mar-Apr;128(2):110-6. doi: 10.1177/003335491312800206.
- Background: PubMed 30450553Whipple NS, Naik RJ, Kang G, Moen J, Govindaswamy SD, Fowler JA, Dowdy J, Penkert R, Joshi VM, Hankins JS. Ventricular global longitudinal strain is altered in children with sickle cell disease. Br J Haematol. 2018 Dec;183(5):796-806. doi: 10.1111/bjh.15607. Epub 2018 Nov 19.
- Background: PubMed 32301178Darbari DS, Sheehan VA, Ballas SK. The vaso-occlusive pain crisis in sickle cell disease: Definition, pathophysiology, and management. Eur J Haematol. 2020 Sep;105(3):237-246. doi: 10.1111/ejh.13430. Epub 2020 May 19.
- Background: PubMed 4536357Modell CB. Haemoglobinopathies. The pathophysiology of beta-thalassaemia major. J Clin Pathol Suppl (R Coll Pathol). 1974;8:12-8. No abstract available.
- Background: PubMed 29222265Taher AT, Saliba AN. Iron overload in thalassemia: different organs at different rates. Hematology Am Soc Hematol Educ Program. 2017 Dec 8;2017(1):265-271. doi: 10.1182/asheducation-2017.1.265.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheinei Alan, MD principal investigator
Inova Fairfax Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deferoxamine, Deferasirox and Deferiprone in people with Sickle Cell Disease, run by Inova Health Care Services at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keary Jane't (571-472-3173, keary.jane't@inova.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hospitalization for Sickle Cell Disease Related Complications (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07023666, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.