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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000923-H

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 110 Years

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Chronic Lymphocytic Leukemia (CLL);
Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia;
Mantle Cell Lymphoma;
Sudden Cardiac Death;
Cardiac Arrhythmias;
Hematologic Malignancies

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Heart, Lung, and Blood Institute

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.

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Eligibility

INCLUSION CRITERIA:

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

a. Currently receiving or planning to receive a BTKi or venetoclax.

b. Male or female, aged 18 or older

c. Stated willingness to comply with all study procedures and availability for the duration of the study

d. 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:

a. Any acute cardiac condition including myocardial infarction or decompensated heart failure within the past 3 months

b. Pregnancy or lactation- use of BTK inhibitors is contraindicated in pregnant or nursing individuals.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Clare C. Sun, M.D.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CRC BG RM 3-5132
10 CENTER DR
BETHESDA MD 20892
(301) 451-7130
clare.sun@nih.gov

Shellin Jose
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 4-5350
10 Center Drive
Bethesda, Maryland 20892
(301) 529-7119
shellin.jose@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05724121

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