Recruiting NCT07023666
Early Screening and Treatment of Heart Complication in Sickle Cell Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deferoxamine, Deferasirox, Deferiprone, Echocardiography.
- Who it may be relevant to
- Registry conditions: Sickle Cell Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Early Detection and Management of Cardiac Iron Overload in Sickle Cell Disease Using Multimodal Imaging for Improved Clinical Outcomes
Overview
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.
Interventions
- Drug Deferoxamine
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. - Drug Deferasirox
Deferasirox is used for iron chelation therapy based on iron burden assessment throughout the study. - Drug Deferiprone
Deferiprone is used for iron chelation therapy used throughout the study. - Device Echocardiography
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. - Device 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.
Primary outcome measures
- Incidence of Hospitalization for Sickle Cell Disease Related Complications [Time frame: Up to 12 months]
- Length of Stay for SCD-Related Complications [Time frame: Up to 12 Months]
Secondary outcome measures (2)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Inova Schar Cancer — Fairfax
- Inova Health Care Service — Falls Church
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. PMID 20029950
- Hamideh 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. PMID 23637037
- Lanzkron 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. PMID 23450875
- Whipple 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. PMID 30450553
- Darbari 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. PMID 32301178
- Modell CB. Haemoglobinopathies. The pathophysiology of beta-thalassaemia major. J Clin Pathol Suppl (R Coll Pathol). 1974;8:12-8. No abstract available. PMID 4536357
- Taher 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. PMID 29222265
Identifiers
NCT: NCT07023666 · INOVA-2023-159