What is the mechanism of action of this treatment?

Common treatments for heart failure include pharmacologic therapies such as ACE inhibitors, beta-blockers, and diuretics, as well as device-based interventions like cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillators (ICDs). ACE inhibitors and beta-blockers work by reducing the workload on the heart and improving its efficiency, while diuretics help to remove excess fluid from the body, reducing symptoms like swelling and shortness of breath. CRT improves the coordination of the heart's contractions, and ICDs prevent sudden cardiac death by correcting life-threatening arrhythmias. These treatments are crucial for heart failure patients as they help manage symptoms, improve quality of life, and reduce the risk of severe complications. Monitoring HRV with devices like the Apple Watch can provide valuable insights into the effectiveness of these treatments and help in early detection of exacerbations, allowing for timely interventions.

What side effects are associated with this type of intervention?

Common treatments for heart failure include ACE inhibitors, beta-blockers, diuretics, and aldosterone antagonists. ACE inhibitors can cause cough, elevated blood potassium levels, and kidney dysfunction. Beta-blockers may lead to fatigue, bradycardia, and hypotension. Diuretics can result in electrolyte imbalances, dehydration, and kidney dysfunction. Aldosterone antagonists may cause hyperkalemia and gynecomastia. Monitoring these side effects is crucial in the management of heart failure.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of heart failure, including beta-blockers like metoprolol and carvedilol, which help manage heart rate and improve heart function. Additionally, ivabradine has been approved for patients with chronic heart failure to reduce heart rate, particularly in those with elevated resting heart rates. These medications are relevant to HRV monitoring as they directly influence heart rate and rhythm, which are critical parameters in managing heart failure.

What other types of research exist?

Promising alternatives to the Apple Watch for HRV monitoring in heart failure patients include the Fitbit Sense 2, which offers advanced heart health monitoring features, and the Garmin Venu 2 Plus, known for its comprehensive health tracking capabilities. Both devices have shown potential in clinical studies for accurate HRV measurement and provide additional metrics such as blood oxygen levels and stress monitoring, which are beneficial for managing heart failure.

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Behavioural Intervention

Apple Watch for Heart Failure

N/A

Waitlist Available

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

No Placebo-Only Group

Summary

This trial uses the Apple Watch to measure heart rate variability in heart failure patients. By tracking changes in the time between heartbeats, it aims to monitor and improve their heart health, potentially reducing hospital readmissions.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference of Standard Deviation of NN Intervals upon Discharge Compared to Admission

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2022

N/A

~550

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart failure include pharmacologic therapies such as ACE inhibitors, beta-blockers, and diuretics, as well as device-based interventions like cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillators (ICDs). ACE inhibitors and beta-blockers work by reducing the workload on the heart and improving its efficiency, while diuretics help to remove excess fluid from the body, reducing symptoms like swelling and shortness of breath. CRT improves the coordination of the heart's contractions, and ICDs prevent sudden cardiac death by correcting life-threatening arrhythmias. These treatments are crucial for heart failure patients as they help manage symptoms, improve quality of life, and reduce the risk of severe complications. Monitoring HRV with devices like the Apple Watch can provide valuable insights into the effectiveness of these treatments and help in early detection of exacerbations, allowing for timely interventions.

Effects of mindfulness-based interventions on health-related outcomes for patients with heart failure: a systematic review.