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New treatment option for Sickle Cell Disease
Official title Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET
ClinicalTrials.gov ID: NCT05583721
What this study is testing
What is [13N]NH3?
[13N]NH3 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sickle cell disease.
Also referred to as [N-13] Ammonia, azane.
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
- There is limited information on what causes injury to the heart in individuals with Sickle Cell Disease (SCD). Researchers in this study want to see if decreased blood flow to the heart during stress could be causing the heart damage seen in SCD patients.
- 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 to 21. Healthy volunteers may be eligible.
You may be able to join if
- Stratum A: Sickle cell patients with diastolic dysfunction
- 18 to 21 years of age
- Black
- Diagnosis of SCD of HbSS and HbSβ0thalassemia genotypes
- Three or more abnormal diastolic parameters (based on guidelines by American Society of echocardiography)
You likely can't join if
- Stratum A:
- Recent hospitalization for vaso-occlusive pain crisis or acute chest syndrome in last 4 weeks
- Blood transfusion in the last 3 months
- Individuals with signs, symptoms or EKG findings of acute myocardial ischemia, infarction or unstable angina
- Individuals with history of VT/VF or SVT
- Previous cardiac surgery
See the full eligibility criteria
- Stratum A: Sickle cell patients with diastolic dysfunction
- 18 to 21 years of age
- Black
- Diagnosis of SCD of HbSS and HbSβ0thalassemia genotypes
- Three or more abnormal diastolic parameters (based on guidelines by American Society of echocardiography)
- Stratum B: Sickle cell patients without diastolic dysfunction
- 18 to 21 years of age
- Black
- Diagnosis of SCD of HbSS and HbSβ0thalassemia genotypes
- Two or less abnormal diastolic parameters
- Stratum C: Healthy controls
- 18 to 21 years of age
- Black
- Two or less abnormal diastolic parameters
- Stratum A:
- Recent hospitalization for vaso-occlusive pain crisis or acute chest syndrome in last 4 weeks
- Blood transfusion in the last 3 months
- Individuals with signs, symptoms or EKG findings of acute myocardial ischemia, infarction or unstable angina
- Individuals with history of VT/VF or SVT
- Previous cardiac surgery
- Known congenital heart disease (other than patent ductus arteriosus or Atrial septal defect)
- Stenotic valvular disease or left main coronary artery stenosis
- History of myo/pericarditis
- Left ventricle systolic dysfunction
- Cardiovascular instability/uncontrolled hypertension (h/o hypertensive urgency or emergency)
- History of sinus node dysfunction or high grade AV nodal block
- History of aborted sudden cardiac death or cardiac arrest
- Current seizure disorder on AED
- Pregnant/Breast-feeding
- Any medical or social reason, which, in the opinion of the principal investigators would make the participation of the subject ill-advised. Exclusion Criteria - Stratum B:
- Diagnosed with three or more abnormal diastolic parameters (based on guidelines by American Society of echocardiography)
- Recent hospitalization for vaso-occlusive pain crisis or acute chest syndrome in last 4 weeks
- Blood transfusion in the last 3 months
- Individuals with signs, symptoms or EKG findings of acute myocardial ischemia, infarction or unstable angina
- Individuals with history of VT/VF or SVT
- Previous cardiac surgery
- Known congenital heart disease (other than patent ductus arteriosus or Atrial septal defect)
- Stenotic valvular disease or left main coronary artery stenosis
- History of myo/pericarditis
- Left ventricle systolic dysfunction
- Cardiovascular instability/uncontrolled hypertension (h/o hypertensive urgency or emergency)
- History of sinus node dysfunction or high-grade AV nodal block
- History of aborted sudden cardiac death or cardiac arrest
- Current seizure disorder on AED
- Pregnant/Breast-feeding
- Any medical or social reason, which, in the opinion of the principal investigators would make the participation of the subject ill-advised. Exclusion Criteria - Stratum C:
- All genotypes of SCD
- Diagnosed with three or more abnormal diastolic parameters (based on guidelines by American Society of echocardiography)
- Anemia of grade 2 or worse (per CTCAE v5.0) at study visit 1
- Individuals with signs, symptoms or EKG findings of acute myocardial ischemia, infarction or unstable angina
- Individuals with history of VT/VF or SVT
- Previous cardiac surgery
- Known congenital heart disease (other than patent ductus arteriosus or Atrial septal defect)
- Stenotic valvular disease or left main coronary artery stenosis
- History of myo/pericarditis
- Left ventricle systolic dysfunction
- Cardiovascular instability/uncontrolled hypertension (h/o hypertensive urgency or emergency)
- History of sinus node dysfunction or high-grade AV nodal block
- History of aborted sudden cardiac death or cardiac arrest
- Current seizure disorder on AED
- Pregnant/Breast- feeding
- Any medical or social reason, which, in the opinion of the principal investigators would make the participation of the subject ill-advised.
The study team makes the final eligibility decision.
Where it's taking place
- Memphis, Tennessee, 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 to 21 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Memphis, Tennessee, 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.