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NCT05724121 · ClinicalTrials.gov registry record
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
A clinical trial of Mantle Cell Lymphoma and Hematologic Malignancies, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Recruiting
- Registry status
- 135
- Enrollment target
- 1
- Study location
NCT05724121: Recruiting study of Mantle Cell Lymphoma and Hematologic Malignancies, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT05724121 is a study of Mantle Cell Lymphoma and Hematologic Malignancies that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 135 participants, above the 103-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (31% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05724121, a study of Mantle Cell Lymphoma and Hematologic Malignancies, is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- RECRUITING
- Registry status
- 135 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Bruton s tyrosine kinase inhibitors (BTKi) are used to treat a form of leukemia. But taking BTKi can also increase a person s risk of developing an abnormal heart rhythm. This can cause sudden death. In this natural history study, researchers want to learn how BTKi affects the heart. Objective: To identify and monitor the effects of BTKi on the heart. Eligibility: People aged 18 and older currently receiving or planning to receive BTKi or venetoclax. Design: Participants who have not yet started BTKi will have 2 required clinic visits: 1 before they start taking BTKi, and 1 about 6 months later. Participants who are already taking BTKi will have 1 required visit. Participants will undergo multiple tests: A physical exam, including collection of blood and saliva. A test that measures heart activity via stickers placed on the chest. A test that uses sound waves to capture images of the heart. An exercise stress test that monitors heart activity and blood pressure while the participant works on a treadmill or stationary bike. Sound wave images of the heart may also be taken while the participant exercises. Stress magnetic resonance imaging (MRI) may be done in place of an exercise test. Participants will lie on a table that slides into a tube. They will be given drugs to stress the heart while images are taken. Participants may wear a device to monitor their heart at home. Participants may have repeat visits if they develop heart symptoms or if they need to stop taking BTKi. They will have follow-up phone calls each year for up to 3 years. ...
Primary Outcome
1\. Clinically significant cardiac arrhythmias while on a BTKi (treatment emergent in those without a history of arrhythmias and worsening of arrhythmia for those with an arrhythmia at the time of enrollment testing) within 12 months. For Cohort A, if a patient has an arrhythmia at the time of baseline testing, only worsening or new arrhythmias will be called an event. For Cohort B, all arrhythmias will be called an event. 2. Sudden death
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2027-04-08 |
What NCT05724121 shows while recruiting
NCT05724121 is an observational study that tracks outcomes without assigning an intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, above the 103-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (31% higher).
The record links to 6 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 0 interventions.
NCT05724121 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05724121 about?
NCT05724121 is a clinical study titled "Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax". Background: Bruton s tyrosine kinase inhibitors (BTKi) are used to treat a form of leukemia. But taking BTKi can also increase a person s risk of developing an abnormal heart rhythm. This can cause sudden death. In this natural history study, researchers want to learn how BTKi affects the heart. O...
What is the current status of trial NCT05724121?
This trial is currently recruiting. The enrollment target is 135 participants. The study started on 2023-03-01. Estimated completion is 2027-04-08.
What conditions does trial NCT05724121 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma, Hematologic Malignancies, Chronic Lymphocytic Leukemia (CLL), Sudden Cardiac Death, Cardiac Arrhythmias.
Who is sponsoring clinical trial NCT05724121?
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 NCT05724121 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05724121's enrollment target sits among peer trials
135 23rd of 102 higher than 80 of 102 other Mantle Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mantle Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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