Recruiting

BTK Inhibitors & Venetoclax

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT05724121

Conditions

Chronic Lymphocytic Leukemia (CLL)

Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia

Mantle Cell Lymphoma

Sudden Cardiac Death

Cardiac Arrhythmias

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Chronic Lymphocytic Leukemia (CLL)

Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia

Mantle Cell Lymphoma

Sudden Cardiac Death

Cardiac Arrhythmias

Study ID

NCT05724121

Start date

Mar 1, 2023

Status verified date

Jul 31, 2026

Completion date

Apr 8, 2027

Anticipated

Primary completion date

Apr 8, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

135 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort A

includes all patients prior to starting therapy with a BTKi

Cohort B

includes all patients already on therapy with a BTKi

Cohort C

includes all patients prior to starting therapy with venetoclax

Primary outcome measure

  • arrhythmogenic cardiac effects of BTKi and sudden death within the first 12 months of BTKi therapy [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Aug 7, 2026

Last verified

Jul 31, 2026

Keywords

  • SUDDEN CARDIAC DEATH
  • Chronic Lymphocytic Leukemia (CLL)
  • Ibrutinib Treatment
  • Atrial Fibrillation/Flutter
  • Ventricular Arrhythmias
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-08-07.