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Behavioural Intervention
Apple Watch for Heart Failure
N/A
Recruiting
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 weeks
Awards & highlights
Study Summary
This trial studies how well the Apple Watch measures heart rate variability in heart failure patients admitted to hospital. Results suggest it could be useful for tracking cardiovascular health.
Who is the study for?
This trial is for individuals aged 22 or older who are hospitalized at Tufts Medical Center with worsening heart failure but have a left ventricular ejection fraction over 35%. They must be able to give consent. It's not for those with pacemakers, arrhythmias like atrial fibrillation, history of heart transplant or assist device, or if pregnant.Check my eligibility
What is being tested?
The study tests if the Apple Watch can accurately measure Heart Rate Variability (HRV) in patients admitted with acute heart failure. The goal is to see an improvement in HRV from when they're admitted to discharge, suggesting that the watch could monitor cardiovascular health.See study design
What are the potential side effects?
Since this trial involves monitoring with an Apple Watch rather than medication, traditional side effects aren't expected. However, there may be discomfort or skin irritation from wearing the device continuously.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference of Standard Deviation of NN Intervals upon Discharge Compared to Admission
Trial Design
1Treatment groups
Experimental Treatment
Group I: Heart Failure PatientsExperimental Treatment1 Intervention
This will be a single arm study of heart failure patients with acute decompensation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apple Watch
2015
N/A
~440
Find a Location
Who is running the clinical trial?
Tufts Medical CenterLead Sponsor
252 Previous Clinical Trials
252,958 Total Patients Enrolled
10 Trials studying Heart Failure
2,696 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a pacemaker for your heart rhythm.You have irregular heartbeats, such as atrial fibrillation or atrial flutter.You have had a heart transplant or a ventricular assist device in the past.You must be 22 years old or older.You were recently hospitalized at Tufts Medical Center for severe heart failure.Your heart's pumping ability is better than 35%.
Research Study Groups:
This trial has the following groups:- Group 1: Heart Failure Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts for this clinical trial still in progress?
"According to clinicaltrials.gov, this trial is inviting enrolment from potential participants and was first posted on May 9th 2022 with the most recent edition occurring on October 13th of that same year."
Answered by AI
What is the aggregate figure for participants in this experiment?
"Yes, the information from clinicaltrials.gov suggests this medical research is presently enrolling participants. The trial was first made available on May 9th 2022 and has been amended most recently on October 13th 2022. 40 subjects need to be recruited at 1 sites."
Answered by AI
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