Cardiomyopathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Criteria that apply to all three groups:

• People aged 60 years or older
• People who are willing and able to sign a consent form and follow the study requirements

Criteria for people with heart failure (with a heart pumping function above 40%), with or without a condition called ATTR-CM (a protein build-up in the heart):

• People whose heart failure and related heart measurements meet specific definitions used by this study (confirm with trial site)
• People whose last heart imaging showed the heart's pumping function was above 40%
• People whose heart walls are thicker than normal, based on specific measurements taken during a heart ultrasound

Additional criterion for the heart failure group without ATTR-CM:

• People who have had a specific bone scan (called a PYP scan) showing no signs of ATTR-CM within the past 24 months, OR whose scores on a specific assessment tool are below a set threshold, OR whose heart tissue biopsy showed no signs of the condition (confirm with trial site for scoring details)

Additional criterion for the heart failure group with ATTR-CM:

• People who have already had ATTR-CM confirmed and classified by a doctor at some point before joining the study, using recognised medical guidelines, and where another similar condition (AL amyloidosis) has been ruled out

Criteria for the healthy comparison (control) group:

• People who have not been diagnosed with heart failure or a heart muscle disease
• People who have not been diagnosed with ATTR-CM or a related protein build-up condition called AL amyloidosis

Who may not be able to join:

Applies to all three groups:

• Women who are pregnant or who have not yet gone through menopause
• People considered vulnerable in a clinical research context (confirm with trial site)
• People who have had a serious heart attack event within the last 30 days
• People whose heart rate is above 130 beats per minute at the time of measurements
• People who are in an irregular heart rhythm called atrial fibrillation or flutter at the time of the study measurements (a past history of this is acceptable if the heart rhythm is normal at the time of the measurements)
• People with any other significant abnormal heart rhythm at the time of the study measurements
• People whose heart is difficult to image clearly by ultrasound
• People with areas of the heart wall that do not move properly due to a previous heart attack
• People with severe disease of the mitral or aortic heart valves, unless that valve disease is caused by ATTR-CM
• People with severe disease of the tricuspid heart valve, unless caused by ATTR-CM
• People where the distance from the skin surface to a specific part of the heart wall is 8 cm or more
• People who have an artificial mechanical heart valve
• People who have a mechanical heart support device (other than a pacemaker or defibrillator)
• People who have had a heart, lung, liver, or kidney transplant, or who are expected to have one within the next year
• People with severely reduced kidney function, end-stage kidney disease, or who are on dialysis
• People with another serious life-threatening illness expected to affect them within the next 12 months
• People with poorly controlled diabetes where there is already damage to organs, based on a specific blood test result
• People with persistently high blood pressure that is not controlled at the time of measurements, above specific thresholds
• People who are in an unstable or acutely unwell state, such as having excess fluid build-up, in the opinion of the study doctor
• People with skin problems, infections, or open wounds at the area where the ultrasound measurements would be taken
• People with at least moderate liver disease

Additional exclusions for both heart failure groups (with and without ATTR-CM):

• People with a known inherited heart muscle disease, another type of protein build-up in the heart (other than ATTR-CM in the relevant group), heart muscle disease linked to muscular conditions, heart muscle disease with a reversible cause, thickened heart muscle disease (hypertrophic cardiomyopathy), or a condition causing stiffness around the heart
• People who have previously been treated with medications that reduce or deplete the TTR protein for ATTR-CM

Additional exclusions for the healthy comparison (control) group:

• People who have any diagnosis of a heart muscle disease or heart failure, regardless of the cause
• People whose heart wall measurements show abnormal thickening, unless a doctor considers this to be due to being a highly trained athlete

Important: Always verify eligibility with the trial site directly before applying.