Lymphoma, Sarcoma
Conditions
Brief summary
The purpose of this study is to find a cost effective cardiovascular (CV) surveillance of cancer survivors over long periods of time to prevent the risk of progression of heart failure (HF) and related morbidity and mortality. Mobile device-based artificial intelligence (AI)-electrocardiogram (ECG) can reliably detect cardiac dysfunction in lymphoma and sarcoma survivors and smart watch based surveillance for cardiotoxicity is feasible and reliable.
Interventions
PROCEDUREElectrocardiogram
All participants receive a standard 12-lead ECG when they present for follow-up 1 year after completion of anthracycline-based therapy. All participants will also record a 6-lead Kardia (AliveCor, Mountain View, CA, USA) and 1-lead Apple Watch (Apple, Cupertino, CA, USA) ECG with Mayo-owned or participant-owned devices. Longitudinal participants will receive an Apple Watch to use during this study if they do not have their own (and agree to download the app) and will be able to transmit ECGs anytime anywhere from their Apple Watch from before the initiation, all through the treatment, up to 1-year after anthracycline-based therapy. For validation, these participants will transmit ECGs from their smart watch at the time of routine follow-up visits (at 3-, 6- & 9-months post therapy visits) along with 6-lead Kardia ECGs, and 12-lead standard ECGs.
PROCEDUREEchocardiogram
All participants will have an echocardiogram as part of standard of care when they present for their follow-up 1 year after completion of anthracycline-based therapy.
PROCEDURELVEF echocardiogram
Participants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit.
OTHERApple Watch
Longitudinal participants will receive an Apple Watch to use during this study if they do not have their own (and agree to download the app) and will be able to transmit ECGs anytime anywhere from their Apple Watch from before the initiation, all through the treatment, up to 1-year after anthracycline-based therapy. For validation, these participants will transmit ECGs from their smart watch at the time of routine follow-up visits (at 3-, 6- & 9-months post therapy visits) along with 6-lead Kardia ECGs, and 12-lead standard ECGs. Longitudinal participants will be asked to transmit weekly cardio fitness (estimates of peak VO2) from baseline to 1-year post therapy.
PROCEDUREBiospecimen collection
Undergo blood draw
OTHERQuestionnaires
Participants fill out 2 questionnaires: 1) the Kansas City Cardiomyopathy-12 (KCCQ-12) Questionnaire, and 2) the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) ore 30 (EORTC QLQ-C30) to evaluate health related quality of life and heart failure symptoms.
Undergo CPET to assess the response of heart and lungs to exercise.
OTHER6 minute walk test
Complete a 6MWT, to see how far participants can walk on a hard, flat surface for 6 minutes
OTHERGrip strength test
A hand-held device called a dynamometer will be used to measure the muscle strength in hand/forearm
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ability to understand study procedures and being willing to comply with them for the entire study length * diagnosis of lymphoma or sarcoma with new start or 1 year after completion of anthracycline therapy
Exclusion criteria
* LVEF \<50% at baseline, or prior confirmed history of heart failure, persistent atrial fibrillation, left bundle branch block, or paced rhythm * Unwilling or unable to give written informed consent * Participants who have opted out of the Minnesota Research Authorization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of left left ventricular ejection fraction (LVEF) <50% by AI-ECG | Baseline to 1 year follow-up | Mobile device ECGs will be compared to standard 12-lead clinic ECGs for the AI algorithm to predict a reduced EF (EF \<50%). |
| Change in AI-ECG based probability of an LVEF <50% using mobile device ECGs | Baseline to 1 year follow-up | The change in probability of abnormal LVEF by AI-ECG using mobile device ECG will be compared between patients who do develop a reduction in LVEF over time versus those who do not. |
| Change in peak VO2 | Baseline to 1 year follow-up | Volume of Oxygen (VO2) will be estimated by the Apple Watch algorithm (developed by Apple Inc.) and reviewed for change from baseline to 1 year. |
Countries
United States
Contacts
Primary ContactTera Peck
Backup ContactClinical Trials Referral Office
Outcome results
None listed