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NCT05213572 · ClinicalTrials.gov registry record
Observational Study to Deeply Phenotype Major Organs in Sickle Cell Disease After Curative Therapies
A clinical trial of Mortality in Sickle Cell and Sickle Cell Cardiopulmonary Complications, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Recruiting
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT05213572: Recruiting study of Mortality in Sickle Cell and Sickle Cell Cardiopulmonary Complications, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT05213572 is a study of Mortality in Sickle Cell and Sickle Cell Cardiopulmonary Complications that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 200 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05213572, a study of Mortality in Sickle Cell and Sickle Cell Cardiopulmonary Complications, is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: People with sickle cell disease (SCD) have problems with their heart, brain, kidneys, liver, and lungs as they age. These problems may improve after transplant. Researchers want to learn how and why this happens. Objective: To study the benefits of treatments that are intended to cure SCD. Eligibility: People aged 18 and older with SCD who are either receiving curative therapy in the next 3 months or don t have any plans to receive a curative therapy in the next 2 years. Design: At their first visit, participants will be screened with their medical history and a physical exam. Participants will then have a baseline visit. This will take about a week to complete and will include: Blood and heart tests MRI of the brain, heart, and lungs. Participants will lie on a bed that will move into the MRI scanner. Special padding may be placed around their head to keep it still. Interactive games. Participants will complete computer games that test memory, attention, problem solving, language, spatial orientation, processing speed, and emotion. Questionnaire rating quality of life Iothalamate test. An IV catheter will be placed into a vein. A contrast agent will be injected through the IV. Blood will then be collected at different time points. Lung function tests and a 6-minute walk test Vibration controlled transient elastography. A probe placed on the abdomen will measure liver scarring. DOS test. A light attached to the finger or toe will measure blood oxygen. Participants will have an end-of-study visit about 2 years after their baseline visit. This will include repeats of the baseline visit tests.
Primary Outcome
Evaluate whether diastolic function improves significantly more in patients who receive curative therapies as compared to those who receive non-curative treatment.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-03-24 |
| Est. Completion | 2035-06-01 |
What NCT05213572 shows while recruiting
NCT05213572 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.
The record links to 5 conditions, with Mortality in Sickle Cell appearing as the primary indexed condition, and to 0 interventions.
NCT05213572 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05213572 about?
NCT05213572 is a clinical study titled "Observational Study to Deeply Phenotype Major Organs in Sickle Cell Disease After Curative Therapies". Background: People with sickle cell disease (SCD) have problems with their heart, brain, kidneys, liver, and lungs as they age. These problems may improve after transplant. Researchers want to learn how and why this happens. Objective: To study the benefits of treatments that are intended to cure...
What is the current status of trial NCT05213572?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2022-03-24. Estimated completion is 2035-06-01.
What conditions does trial NCT05213572 study?
This clinical trial studies the following conditions: Mortality in Sickle Cell, Sickle Cell Cardiopulmonary Complications, Sickle Cell Organ Damage, Sickle Cell Life Expectancy and Risk Factors for Early Death, Sickle Cell Lung Disease and Sudden Death.
Who is sponsoring clinical trial NCT05213572?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05213572 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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