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A wearable device and your smartphone will be used in this study.
What is Heart Failure?

Heart failure is a serious, long-term condition in which the heart doesn't pump blood as well as it should. A healthy heart ensures that oxygen-rich blood is delivered to your cells, heart and body to function normally. When your cells do not receive enough oxygen, you experience shortness of breath, become tired faster than normal, and may have coughing spells. These symptoms can progress, making daily simple tasks increasingly more difficult to complete.

More than 6 million Americans live with heart failure, with over 900,000 new cases diagnosed each year.* Most people with heart failure have already experienced other forms of heart disease such as high blood pressure, coronary artery disease, and/or previous heart attack. Heart failure is managed by changes in diet, exercise levels, and other lifestyle changes. It is also often treated with medicine to help increase the quality of life and extend the lifespan.

*Source: American Heart Association, Inc. (2019) Causes and Risks for Heart Failure.
Retrieved from: https://www.heart.org/en/health-topics/heart-failure/causes-and-risks-for-heart-failure

What is a Virtual Study?

Most clinical trials require participants to make multiple visits to a clinic, hospital, or doctor’s office for study tests, labs and other procedures. The CHIEF-HF study is a virtual study. This means you will complete study questionnaires and provide information through a smartphone study app and a study-provided Fitbit device that will be sent to you. You will not be required to travel to a research clinic for this study. Additionally, a virtual study team will be available via a call-center during the study to answer your study-related questions.

Just like other clinical trials, this virtual study will be reviewed and monitored by an independent review board (IRB) who will help to ensure that the study is conducted safely and that the rights and safety of study participants are protected.

What Can I Expect if I Participate in the CHIEF-HF Study?

You will be asked to complete multiple questionnaires, but you will not be required to travel for any study visits.

The study is divided into different parts and participation lasts about 9 months.

1
Screening
months 0-1
After completing the technical pre-screening questions, you will be notified right away if you are potentially eligible for the study. If you pre-qualify, you will complete a short form providing your contact information, and someone from the study team will contact you. During this time, the study doctor will review your eligibility for the study using information from your Electronic Medical Record. If you qualify for participation, a study doctor will review the study details with you on the phone before you sign your Informed Consent Form (ICF), also known as eConsent. *See below for more information about eConsent.
2
Study Treatment
months 1-3
If you do decide to sign the eConsent Form, you will complete one questionnaire which will confirm if you are able to be a part of the study. If you meet the criteria to be a part of the study, you will receive a Fitbit device in the mail and your study drug will be delivered to you. Note that the study drug may be either the investigational medication or a placebo, which will randomly be assigned. Neither you nor your Health Care Provider will know which type of capsule you will receive until after you stop taking it. During the first 3 months of the study, you will (1) take the study drug in capsule form every day, (2) wear the study provided Fitbit device, and (3) answer the required questionnaires using the app on your smartphone at the following timepoints: Weeks 2, 4, 6, and 3 months.
3
Follow up
months 4-9
After taking the study drug every day for 3 months, you will stop taking the capsules. You will continue to (1) wear the study provided Fitbit device, and (2) answer the required questionnaires at 6 and 9 months using the app on your smartphone. At the end of the 9 months, you will also be asked to complete a survey about your participation in this study. All questionnaires and the final survey will be completed via the app on your smartphone.
eConsent
* In this particular study, we use an electronic ICF (eConsent) that you will electronically sign either using the study app on your smartphone or a web browser (e.g., Internet Explorer or Chrome). The eConsent will explain to you all about the study, procedures, and what will be expected of you if you decide to participate. It will also explain to you the risks and benefits of participation as well as your rights as a research participant. The study doctor will make sure you understand the eConsent before you decide to participate.

Want to Learn More?

Watch the video below for a brief description of the CHIEF-HF study and what would be required, if you choose to participate.
Click here to download a transcript of the video.
Why Participate in the CHIEF-HF Clinical Research Study?

Participation may result in an improvement of heart failure symptoms, or in no improvement at all. It is also possible that some participants may feel worse. If you are assigned to receive the investigational medication, you may experience side effects. These potential side effects are listed in the Informed Consent Form that you will read prior to participating. You should ask questions and discuss any concerns with the study doctor during the eConsent phone call.

Taking part in a clinical trial is completely voluntary. Participation is not required, and if enrolled in a clinical study, you can choose to end participation at any time and for any reason.

What is Clinical Research?

A clinical research study (also known as a clinical trial) is designed to evaluate how safe and effective an investigational drug is in treating a specific disease or condition. The results of clinical studies help regulatory agencies like the U.S. Food and Drug Administration (FDA) decide if an investigational drug should be made available to patients. Clinical trials are the only way we can develop new and better treatments and improve patient care.

Every clinical study is reviewed by an independent review board (IRB) who helps ensure that the study is conducted safely and that the rights and safety of study participants are protected. Clinical studies are conducted by experienced and trained medical professionals who monitor the health of participants during the study.

Frequently Asked Questions

Why have I been contacted about this study?
The healthcare network system where you receive medical care believes that you may be eligible for the study. Your answers to the pre-screening questionnaire will help determine if you could participate. If you pre-qualify, we will collect your contact information and review your medical records with your healthcare network system to confirm if you can be in the study.
What about my regular doctors?
You or the study staff (if you allow them) may let your Primary Healthcare Provider know that you’re in this study. You will be provided a study information card to give to your primary provider(s) with the Care Innovations Support team phone number in case they have questions or provide us any information about you. It is important for your other doctors to know when you join a research study.
Do I get to keep the study provided Fitbit device?
No. You will be provided a return label for the Fitbit device in your initial shipment package. You will be required to return your Fitbit device at the end of the study.
How often do I have to wear the Fitbit device?
Wear the Fitbit device every day and as much as possible. It is waterproof and can be worn when bathing, swimming, sleeping, and during most other normal activities. You also have to keep the Fitbit device charged.
What do I do if the Fitbit device gets damaged or stops working?
If you have problems with the Fitbit device, contact the study support team at 1-855-949-1669.
What kind of smartphone do I need to participate in the CHIEF-HF study?
You will need to have an Apple iOS or Samsung Android OS device to participate in this study. This includes any iPhone 6 models and later, as well as Samsung 7 models and later (this also includes future models that may be launched during your enrollment period).
Will the study cost me anything? Will I be paid?
The study will not cost you anything. The sponsor will pay for the study drug that is part of the study, as well as the Fitbit device. The sponsor will not pay for doctor visits, treatments, or tests that are not part of this study. This means that you, your insurance company, or your government health plan are responsible for your regular healthcare visits. You must also provide your own smartphone and internet connection to use during the study.
You will be reimbursed for time and effort spent in completing the questionnaires. You will not be paid for questionnaires you did not complete. You will not be paid for taking the pre-screening questionnaire.
What is an IRB?
An IRB (institutional review board) is made up of medical professionals, scientists, and community members who review the study plans and help to ensure that the study is conducted safely and that the rights and safety of study participants are protected.
What is Informed Consent?
Informed Consent means that the details of the study, the study drug, your obligations, the benefits, risks, your right to privacy, and your right to withdraw from the study at any time have all been explained to you and you understand them. This information is summarized in a document called the Informed Consent Form (ICF). The study doctor will review the ICF with you after you pass the pre-screening questionnaire to ensure all your questions are answered. In this particular study, we use electronic ICF (eConsent), where your understanding of the study and your agreement to participate are captured either in an app on your smartphone or by using a web browser (e.g., Internet Explorer or Chrome) instead of by signing a paper form.
Do I have to participate in the CHIEF-HF study?
No. Your participation in the CHIEF-HF study is completely voluntary. If you decide not to participate it will not change the level of healthcare you currently receive. If you choose to participate you can end your participation later at any time and for any reason.