Recruiting

Cardiovascular Surveillance

Sponsor:

Mayo Clinic

Code:

NCT07058064

Conditions

Lymphoma

Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electrocardiogram

Echocardiogram

LVEF echocardiogram

Apple Watch

Biospecimen collection

Study Details

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.

Conditions

Lymphoma

Sarcoma

Study ID

NCT07058064

Start date

Jul 18, 2025

Status verified date

Oct, 2025

Completion date

Jun 29, 2029

Anticipated

Primary completion date

Jun 29, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: Cross-sectional Arm

Lymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy.

experimental: Longitudinal Arm

Lymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment.

Interventions

Electrocardiogram

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.

Echocardiogram

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.

LVEF echocardiogram

Participants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit.

Apple 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.

Biospecimen collection

Undergo blood draw

Questionnaires

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.

Cardio-pulmonary exercise test

Undergo CPET to assess the response of heart and lungs to exercise.

6 minute walk test

Complete a 6MWT, to see how far participants can walk on a hard, flat surface for 6 minutes

Grip strength test

A hand-held device called a dynamometer will be used to measure the muscle strength in hand/forearm

Primary outcome measure

  • Detection of left left ventricular ejection fraction (LVEF) <50% by AI-ECG [ Time Frame: Baseline to 1 year follow-up ]
  • Change in AI-ECG based probability of an LVEF <50% using mobile device ECGs [ Time Frame: Baseline to 1 year follow-up ]
  • Change in peak VO2 [ Time Frame: Baseline to 1 year follow-up ]

Central Contacts and Locations

Central contacts

Tera Peck

507-266-2123Peck.Tera@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Tera Peck

507-538-7425Peck.Tera@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Joerg Herrmann, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 15, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-10-15.