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NCT03838627 · ClinicalTrials.gov registry record
Feasibility and Agreement of Remote Evaluation of Resting Heart Rate and Heart Rate Variability in Survivors of Hodgkin Lymphoma Treated With Chest Radiation (PILOT STUDY-SURVIVOR)
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 34
- Enrollment target
NCT03838627: Completed study, sponsored by St. Jude Children's Research Hospital.
NCT03838627 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 34 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03838627 has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 34 participants
- Enrollment target
Study Summary
Primary Objective The objective is to determine the feasibility and agreement of remote evaluation of resting heart rate and HRV using the commercially available WHOOP® wrist monitor, compared to in-office measurements using AtCor Medical SphygmoCor HRV Software, in a cohort of 40 St. Jude Life Study participants with a history of mantle radiation for management of Hodgkin lymphoma. Elucidating the mechanisms that contribute to adverse cardiovascular outcomes and reduced quality of life among the growing population of childhood cancer survivors is paramount. Cancer, certain cancer drugs, radiation therapy, cancer-associated lifestyle disturbances, and cancer-independent comorbidities combine to predispose cancer survivors to autonomic dysfunction (AD). Reduced heart rate variability (HRV) has been described in various cancer cohorts. Furthermore, these markers of AD have been implicated in adverse outcomes in oncology patients, including increased mortality, exercise limitation, and fatigue. However, data are largely derived from small studies with methodological limitations, and the contribution of AD to overall morbidity and mortality in cancer survivors is not well understood. The objective is to determine the feasibility and agreement of remote evaluation of resting heart rate and HRV using the commercially available WHOOP® wrist monitor, compared to in-office measurements using AtCor Medical SphygmoCor HRV Software, in a cohort of 40 St. Jude Life Study participants with a history of mantle radiation for management of Hodgkin lymphoma.
Primary Outcome
Feasibility will be considered adequate if 30 of 40 participants have at least 3 hours of HRV data from the home wearing period.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-02-05 |
| Est. Completion | 2023-06-30 |
What the finished NCT03838627 record still lists
NCT03838627 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 34 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03838627 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03838627 about?
NCT03838627 is a clinical study titled "Feasibility and Agreement of Remote Evaluation of Resting Heart Rate and Heart Rate Variability in Survivors of Hodgkin Lymphoma Treated With Chest Radiation (PILOT STUDY-SURVIVOR)". Primary Objective The objective is to determine the feasibility and agreement of remote evaluation of resting heart rate and HRV using the commercially available WHOOP® wrist monitor, compared to in-office measurements using AtCor Medical SphygmoCor HRV Software, in a cohort of 40 St. Jude Life Stud...
What is the current status of trial NCT03838627?
This trial is currently completed. The enrollment target is 34 participants. The study started on 2019-02-05. Estimated completion is 2023-06-30.
Who is sponsoring clinical trial NCT03838627?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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