Purpose of the Study

This research is being done to learn more about what causes heart failure, which is a medical condition in which the heart does not keep up to the demands of the body, resulting in shortness of breath and swelling. People who have early-stage heart failure or are at risk for heart failure may not know that they have heart failure because they feel well. Some people who have heart failure may experience many symptoms and some experience very few symptoms. HeartShare is studying why some people develop heart failure while others do not. In addition, HeartShare aims to better categorize heart failure into subtypes that can be targeted with specific treatments. In order to learn this information, the study team is recruiting people who do and or do not have heart failure.

The goal of the HeartShare study (STU00217900) is to improve the classification and treatment of heart failure with preserved ejection fraction (HFpEF) by categorizing HFpEF into different subtypes. To accomplish this, we are enrolling people with all types of heart failure as well as people without a diagnosis of heart failure in a registry.

The HeartShare Registry is completely remote; participants who participate will contribute to new research by taking health surveys online using either a phone or computer. The study team will also send you information on participating in additional study opportunities outside of the surveys; you will be able to choose whether you would like to participate in these new opportunities as they arise. 

What is involved?

HeartShare Registry

  • Participation in this research study is expected for up to 5 years.
  • Completely remote study (no in-person visits).
  • Notification via smartphone, email, and/or text message will indicate when there are new survey questions or activities that are open for completion. Surveys can be taken on your smartphone with the Eureka app, on a computer with our web portal, or by phone with someone from the study team. The surveys and activities are as follows:
    • Surveys asking about demographics, health, and family history will be sent out at time of enrollment and every 6 months via phone or online survey.
    • Short monthly survey (3- Questions) for any updates or changes to your health.
    • Short assessments and questionnaires will be performed every 6 months remotely, conducted via phone or online data portal.
  • There are additional study opportunities that are optional to participate in.

HeartShare Deep Phenotyping

  • Participation in this research study is expected for up to 5 years.
  • Monthly surveys will be completed via phone or online in the Eureka app. Questions will be about your health since the last contact.
  • Clinical Visits 
    • You will be needed for 5-7 hours per day for two days for the baseline examination. The examination will include as follows:
      • Height, weight, waist, hips, blood pressure and pulse; interview of your health; collection of blood, urine, stool, and saliva samples; walking test; electrocardiogram; echocardiogram; cardiopulmonary exercise test; peripheral arterial tonometry; and arterial stiffness applanation tonometry measurement. CT of the chest, abdomen, and thigh; MRI of the heart and liver; and a lung function test. There will be an optional assessment of fat and muscle tissue with a small biopsy. 
    • Follow up in-person visits will occur annually (every 12 months). These visits will include as follow:
      • Clinical exam, electrocardiogram, walking test, and blood and urine collection.
      • Asked to share information about your health and participation in the study.

Who is eligible?

HeartShare Registry

To be eligible to participate you must:

  • Be at least 30 years old.
  • Have a prior diagnosis of HF in your electronic health record.
  • NOT have a prior history of solid organ transplantation.
  • NOT have a prior history of mechanical circulatory support.
  • NOT have a prior history of non-cardiac cirrhosis.
  • Be able to understand and provide informed consent to participate in this research.

HeartShare Deep Phenotyping

  • Be at least 30 years old.
  • Have a left ventricular ejection fraction ≥50%.
  • Meet the definition of HFpEF: signs and symptoms of HF, NYHA functional class II-IV, and at least one of the following: 
    • Elevated BNP  or NT-proBNP. Choice of BNP or NT-proBNP is based on availability at each clinical center.
    • Prior HF hospitalization.
    • Elevated pulmonary capillary wedge pressure (PCWP) at rest  or during exercise.
    • Elevated H2FPEF score or HFA-PEFF score.
  • NOT have a life expectancy estimated to be less than 1 year.
  • NOT have primary cardiomyopathy (including amyloid, hypertrophic cardiomyopathy, cardiac sarcoidosis, hemochromatosis, or other infiltrative cardiomyopathies) or pulmonary arterial hypertension (WHO Group I, III, or IV pulmonary hypertension).
  • NOT have a prior known left ventricular ejection fraction <40%, except if this occurred only in the setting of an acute tachycardia episode (e.g., acute atrial fibrillation).
  • NOT have a clinically significant valvular heart disease defined as: 
    1. Moderate to greater aortic stenosis, pulmonic stenosis, or tricuspid stenosis.
    2. Any mitral stenosis.
    3. Moderate or greater aortic regurgitation.
    4. Greater than moderate mitral regurgitation.
  • NOT have a planned cardiac surgery or cardiac intervention in the next 3 months.
  • HFpEF is the primary reason for symptoms of shortness of breath and exercise intolerance in the opinion of the enrolling investigator.
  • NOT have any cardiac surgery, acute coronary syndrome, percutaneous coronary intervention, stroke, transient ischemic attack, or carotid intervention in the preceding 6 months prior to enrollment.
  • NOT have known symptomatic epicardial coronary artery disease that is not revascularized.
  • NO hospitalization in the preceding 2 weeks.
  • NOT have a history of solid organ transplantation.
  • NO prior history of chronic infection (HIV, hepatitis C, hepatitis B, tuberculosis) unless treated and not clinically active in the opinion of the enrolling investigator.
  • NO prior history of mechanical circulatory support.
  • NO prior history of non-cardiac cirrhosis.
  • NOT currently on dialysis.
  • NOT have any condition that may preclude participation or adherence to the study protocol, in the opinion of the enrolling investigator.
  • Have ability to provide written consent to the study.
  • NO current acute decompensated heart failure.
  • NOT currently pregnant.