Assessing Wearable Activity in Relation to Endurance in Heart Failure (AWARE-HF) 

The AWARE-HF study is researching clinical assessments with new digital measures including ActiGraph™ CentrePoint Insight Watch.

Who may participate

Joining a clinical trial is an important and personal decision. Your doctor may have mentioned the AWARE-HF study, or perhaps you found your way here by yourself. Either way, thank you for your interest. 

To qualify for this study, you must:

  • Be able to give written informed consent.
  • Be male or female 18 years of age or older at screening visit.
  • Confirmed diagnosis of heart failure and echocardiography results available within 12months prior to enrollment.
  • Previous clinical diagnosis of heart failure with NYHA Class II-IV symptoms at screening visit and present for at least 1 month.
  • Stable cardiovascular medical therapy for at least 30 days, defined as no addition, removal, or major (>2-fold) dose change of prescribed medications for the treatment of cardiovascular disease other than diuretic titration at screening visit.
  • Be willing and able to comply with all scheduled visits, laboratory tests, and other study procedures

Condition

NYHA Class II-IV chronic heart failure

Age

18+ years

Requirements

There are other requirements for participation in the study. The study doctor will explain these to you.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

Interested in understanding more about the study?

Purpose

Purpose
Purpose

Purpose

We are developing therapies to treat patients with heart failure. Traditionally, heart failure clinical trials have largely focused on survival and hospitalizations rather than on improvement of symptoms such as shortness of breath and fatigue, physical activity, and day to day functioning.  With improvements in new technologies, it is now possible to measure day to day physical activity at home with wearable sensors and to use digital health technologies (DHTs) to ask questions around disease symptoms at home.

Overview

Pfizer is conducting a study to recruit 120 participants with heart failure symptoms in three ranges based on the New York Heart Association Functional Classification, or NYHA:

  • people with slight limitation to activity and mild symptoms such as fatigue, palpitations and shortness of breath during physical activity but who have no symptoms while resting.
  • people with more severe limitations to physical activity but who are comfortable at rest and
  • people who cannot undergo physical activity without discomfort and who have symptoms of heart failure even at rest.

There will be a total of 6 in-clinic visits over the course of one year. Participants will visit the site at their first visit, and then again after 1 month, 3 months, 6 months, 9 months, and 12 months. At each visit, the participants will complete activities to help measure their physical function and will also complete questionnaires about their symptoms and quality of life. At the end of each visit, participants will also be sent home with a digital health technology, or DHT, to assess physical activity and symptoms in between clinic visits.

Overview

Overview
Overview

Technologies

AG
AG

Technologies

Accelerometry

The devices looks and is worn on your wrist like a watch. As you go about your daily activity the device will passively capture and record acceleration, activity, and sleep data. 

Frequently Asked Questions

What is the study about?

The AWARE-HF study is researching clinical assessments with new digital measures including ActiGraph™ CentrePoint Insight Watch.

Is this helpful?
What technologies will I use?

The ActiGraph™ CentrePoint Insight Watch is worn on your wrist like a traditional watch. As you go about your daily activity the device will passively capture and record acceleration, activity, and sleep data. 

Is this helpful?
Am I eligible to participate?

If you have been diagnosed with heart failure within the last year, you may qualify. Please refer to 'Who may Participate' to view requirements. 

Is this helpful?
Where can I participate?

AWARE-HF has locations for study visits across the US. Please refer to 'Locations' to see which location may be closest to you.

Is this helpful?
How do I sign-up?

To learn more about study locations and contact information, please refer to 'Locations.'

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Learn more

Locations

Recruiting
Biopharma informatics, LLC

19255 Park Row Dr Suite 205, Houston, TX 77084

Principal Investigator: Dr. Amir Azeem, Phone: 281-944-3610. Email: [email protected].

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Recruiting
Angiocardiac Care of Texas

10021 S Main St # B1, Houston, TX 77025

Principal Investigator: Dr. Amin Karim, Phone: 281-944-3610. Email: [email protected].

Google Maps
Recruiting
Complete Cardiovascular Center of Monroe

1100 North 18th Street, Suite 100, Monroe, LA 71201

Principal Investigator: Dr. Mark C. Napoli, Phone: 318.361.9900

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Recruiting
Grace Research LLC

2400 Hospital Drive, Suite 360, Bossier City, LA 71111

Principal Investigator: Dr. William Eaves, Phone: 318.626.5180

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Recruiting
Orange County Research Center

14351 Myford Road, Suite B, Tustin, CA 92780

Principal Investigator: Dr. Joel Neutel, Phone: 714.550.9990

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Recruiting
Southwest Family Medicine Associates

8877 Harry Hines Blvd, Dallas, TX 75235

Principal Investigator: Dr. Chrisette Dharma, Phone: 214.393.2940, Email: [email protected]

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Recruiting
Louisiana State University Healthcare

3601 Houma Blvd, Suite 300, Metairie, LA 70006

Principal Investigator: Dr. Frank Smart, Phone: 504.412.1390

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Recruiting
Laurelton Heart Specialists

234-36 Merrick Blvd, 2nd floor, Queens, NY 11422

Principal Investigator: Dr. Ola Akinboboye, Phone: 718.949.9400, Website: https://www.topheartdoctors.com/provider/ola-akinboboye-md-mph-mba

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