It has recently been described that ATTR-CM is significantly underdiagnosed and may be more common than current estimates.

The most frequent form of heart failure in people with ATTR-CM is heart failure with preserved ejection fraction. Heart failure with preserved ejection fraction is also the most common form of heart failure in adults and accounts for up to 50% of heart failure-related hospital admissions.

Who may participate

People who take part in clinical trials are key to advancing medical research. Thank you for considering this study.

This study may be an option if you’re diagnosed with heart failure and you:

  • Had at least 1 episode of heart failure symptoms with or without hospitalization that required treatment
  • Do not have any type of diagnosed amyloidosis (e.g., amyloid A amyloidosis, primary light chain amyloidosis) or prior diagnosis of ATTR-CM

If you choose to participate, you will sign the informed consent document and continue with a screening visit, to confirm whether you meet the eligibility criteria and are able to participate.

Condition

Heart failure with preserved ejection fraction

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Age

60+ years

The age a person must be to participate in a clinical trial.

Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

 

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.

Get started – See if you may qualify

The following questions are voluntary and will take approximately 5 minutes to complete. These questions are designed to evaluate if you are potentially eligible to participate in this study. We will ask questions about your health and some questions may be personal in nature. You may choose to stop the questionnaire at any time.  Completing this questionnaire does not mean that you are eligible to enroll in a Pfizer clinical trial as only the research staff can determine if you qualify to enroll in the study.

 

 

What to expect

If you choose to participate in the study, you will undergo a screening process and a physical exam that includes an echocardiogram (ultrasound of the heart).  If enrolled, you will be asked for information on your current medications.  You will also have additional tests, such as an imagine heart scan (called scintigraphy) that allows the study doctor to see how well your heart is functioning. You will also have blood and urine tests to determine if you have ATTR-CM.

There is no study medicine being given to participants in this clinical trial and the study does not involve any change in your current treatment. Determining what type of heart failure you have may help your doctor determine the best treatment plan for you.

Length of study participation

Approximately 2 to 9 months depending on diagnosis

Length of study participation is the length of time people will participate in the study if they enroll.

Number of study visits

Up to 4 clinic visits, 2 may be conducted by phone

 Each clinical trial’s design specifies the number of study visits and the total length of the trial.

About Transthyretin amyloid cardiomyopathy (ATTR-CM)

Transthyretin amyloid cardiomyopathy, or ATTR-CM, is a type of cardiac amyloidosis and a cause of heart failure that is often underdiagnosed.

Because of the impact ATTR-CM has on the heart, the disease often presents with the symptoms of heart failure but may also include other symptoms related to buildup of amyloid fibrils throughout the body. Common symptoms of ATTR-CM include:

  • Fatigue
  • Shortness of breath
  • Irregular heartbeat
  • Gastrointestinal problems such as diarrhea, constipation, nausea, or feeling full quickly
  • Carpal tunnel syndrome, numbness, tingling, and pain in the fingers
  • Hip and/or knee replacement
  • Pain or numbness in lower back and legs
  • Swelling in the lower legs

While these signs and symptoms don’t necessarily indicate that you have ATTR-CM, if you have heart failure, any one or combination should be mentioned to your cardiologist.