Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax

Study tracks heart rhythm changes in patients taking certain leukemia drugs

NCT: NCT05724121 · Status: RECRUITING · Phase: N/A · Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · Started: 2023-03-01 · Est. Completion: 2027-04-08

Plain English Summary

Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax is a Not Applicable clinical trial sponsored by National Heart, Lung, and Blood Institute (NHLBI) studying Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia, Mantle Cell Lymphoma, Sudden Cardiac Death, Cardiac Arrhythmias, Hematologic Malignancies. This study observes how two types of drugs, BTK inhibitors and venetoclax, affect heart rhythms in patients with certain blood cancers. It is for adults aged 18 and older who are currently taking or planning to start these medications. Participation involves clinic visits for heart monitoring tests (like ECG, echocardiogram, stress tests) and possibly wearing a heart monitor at home. There are no alternative treatments being tested in this study; it is observational. The trial aims to enroll 135 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 18 or older and are currently taking or will soon start BTK inhibitors or venetoclax for a blood cancer. You cannot join if you have had a heart attack or severe heart failure in the last 3 months, or if you are pregnant or breastfeeding. Willingness to follow study procedures and attend all appointments is required. This trial is studying Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia, Mantle Cell Lymphoma, Sudden Cardiac Death, Cardiac Arrhythmias, Hematologic Malignancies, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if these drugs cause abnormal heart rhythms or sudden death within the first year of treatment, helping doctors identify and manage these risks. The specific primary outcome measures are: arrhythmogenic cardiac effects of BTKi and sudden death within the first 12 months of BTKi therapy (12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This study is important because it aims to understand and monitor potential heart rhythm problems caused by common leukemia treatments, filling a gap in knowledge about these risks. This research targets Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia, Mantle Cell Lymphoma, Sudden Cardiac Death, Cardiac Arrhythmias, Hematologic Malignancies, where improved treatment options are needed.

Investor Insight

This observational study focuses on a known side effect of BTK inhibitors, a growing class of drugs for blood cancers, suggesting a need for better cardiac monitoring in this patient population.

Is This Trial Right for Me?

Ask your doctor about the specific risks of heart rhythm changes with your prescribed medication. Be prepared for clinic visits that may include physical exams, blood tests, and various heart monitoring tests. You might need to wear a heart monitor at home for a period, and follow-up calls will occur annually for up to three years. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

* INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. Currently receiving or planning to receive a BTKi or venetoclax.
2. Male or female, aged 18 or older
3. Stated willingness to comply with all study procedures and availability for the duration of the study
4. Ability of subject to understand and the willingness to sign a written informed consent document

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Any acute cardiac condition including myocardial infarction or decompensated heart failure within the past 3 months
2. Pregnancy or lactation- use of BTK inhibitors is contraindicated in pregnant or nursing individuals.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT05724121?

NCT05724121 is a Not Applicable OBSERVATIONAL study titled "Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax." It is currently recruiting and is sponsored by National Heart, Lung, and Blood Institute (NHLBI). The trial targets enrollment of 135 participants.

What conditions does NCT05724121 study?

This trial investigates treatments for Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia, Mantle Cell Lymphoma, Sudden Cardiac Death, Cardiac Arrhythmias, Hematologic Malignancies. The primary condition under study is Chronic Lymphocytic Leukemia (CLL).

What does Not Applicable mean for NCT05724121?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT05724121?

This trial is currently "Recruiting." It started on 2023-03-01. The estimated completion date is 2027-04-08.

Who is sponsoring NCT05724121?

NCT05724121 is sponsored by National Heart, Lung, and Blood Institute (NHLBI). The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05724121?

The trial aims to enroll 135 participants. The trial is currently recruiting and accepting new participants.

How is NCT05724121 designed?

This is a observational study.

What are the primary outcomes being measured in NCT05724121?

The primary outcome measures are: arrhythmogenic cardiac effects of BTKi and sudden death within the first 12 months of BTKi therapy (12 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05724121 being conducted?

This trial is being conducted at 1 site, including Bethesda, Maryland (United States).

Where can I find official information about NCT05724121?

The official record for NCT05724121 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05724121. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05724121 testing in simple terms?

This study observes how two types of drugs, BTK inhibitors and venetoclax, affect heart rhythms in patients with certain blood cancers. It is for adults aged 18 and older who are currently taking or planning to start these medications.

Why is this trial significant?

This study is important because it aims to understand and monitor potential heart rhythm problems caused by common leukemia treatments, filling a gap in knowledge about these risks.

What are the potential risks of participating in NCT05724121?

The main risk is the potential for developing abnormal heart rhythms, which could lead to serious complications. Other potential side effects are related to the specific heart tests performed, such as discomfort during an exercise stress test or MRI. Pregnancy and breastfeeding are reasons to be excluded due to contraindications with BTK inhibitors. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05724121?

Ask your doctor about the specific risks of heart rhythm changes with your prescribed medication. Be prepared for clinic visits that may include physical exams, blood tests, and various heart monitoring tests. You might need to wear a heart monitor at home for a period, and follow-up calls will occur annually for up to three years. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05724121 signal from an investment perspective?

This observational study focuses on a known side effect of BTK inhibitors, a growing class of drugs for blood cancers, suggesting a need for better cardiac monitoring in this patient population. This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves clinic visits for heart monitoring tests (like ECG, echocardiogram, stress tests) and possibly wearing a heart monitor at home. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.