Trial Outcomes & Findings for Screening for Cardiac Amyloidosis With Nuclear Imaging for Minority Populations (NCT NCT03812172)
NCT ID: NCT03812172
Last Updated: 2025-11-19
Results Overview
The prevalence of ATTR cardiac amyloidosis was calculated from among the number of subjects within the cohort determined to be ATTR-CA positive. Determination of ATTR-CA was defined as significant myocardial retention of Tc-99 PYP. The prevalence is expressed as a percentage of total enrollment. ATTR-CA prevalence is reported for two different groups: Self-identified as Black, subjects with Heart Failure and Self-identified as non-Black, subjects with Heart Failure.
COMPLETED
646 participants
Study Participation of One Year
2025-11-19
Participant Flow
Black and Hispanic Caribbean patients with heart failure were recruited from North Manhattan (NYP West and Harlem Hospitals), Boston and New Haven via academic research facilities at Columbia University Irving Medical Center, Boston Medical Center and Yale/New Haven Health Center from 5-19-2019 until 6-12-2024
Participant milestones
| Measure |
Self-Identified Black Race Participants With Heart Failure
ATTR-CA prevalence among subjects with heart failure self-identified as Black within predefined categories, (i.e., overall, men, women, Hispanic ethnicity age ≤75 and age \>75)
Transthyretin cardiac amyloidosis status was determined by 99mTc-PYP (or 99mTc-HDP) scintigraphy.
Those with transthyretin cardiac amyloidosis were further subtyped into those with a genetic cause (ATTRv) variant transthyretin cardiac amyloidosis and those with a non-genetic cause (ATTRwt - wild-type transthyretin cardiac amyloidosis).
|
Self-identified Non-Black Participants With Heart Failure:
ATTR-CA prevalence among subjects with heart failure not self-identified as Black within predefined categories, (i.e., overall, men, women, Hispanic ethnicity age ≤75 and age \>75)
Transthyretin cardiac amyloidosis status was determined by 99mTc-PYP (or 99mTc-HDP) scintigraphy.
Those with transthyretin cardiac amyloidosis were further subtyped into those with a genetic cause (ATTRv) variant transthyretin cardiac amyloidosis and those with a non-genetic cause (ATTRwt - wild-type transthyretin cardiac amyloidosis).
|
|---|---|---|
|
Overall Study
STARTED
|
550
|
96
|
|
Overall Study
COMPLETED
|
550
|
96
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Screening for Cardiac Amyloidosis With Nuclear Imaging for Minority Populations
Baseline characteristics by cohort
| Measure |
Self-Identified as Black, Subjects With Heart Failure
n=550 Participants
ATTR-CA prevalence among subjects with heart failure self-identified as Black within predefined categories, (i.e., overall, men, women, Hispanic ethnicity age ≤75 and age \>75)
Transthyretin cardiac amyloidosis status was determined by 99mTc-PYP (or 99mTc-HDP) scintigraphy.
Those with transthyretin cardiac amyloidosis were further subtyped into those with a genetic cause (ATTRv - variant transthyretin cardiac amyloidosis) and those with a non-genetic cause (ATTRwt - wild-type transthyretin cardiac amyloidosis).
|
Self-identified as Non-Black, Subjects With Heart Failure
n=96 Participants
ATTR-CA prevalence among subjects with heart failure not self-identified as Black within predefined categories, (i.e., overall, men, women, Hispanic ethnicity age ≤75 and age \>75)
Transthyretin cardiac amyloidosis status was determined by 99mTc-PYP (or 99mTc-HDP) scintigraphy.
Those with transthyretin cardiac amyloidosis were further subtyped into those with a genetic cause (ATTRv - variant transthyretin cardiac amyloidosis) and those with a non-genetic cause (ATTRwt - wild-type transthyretin cardiac amyloidosis).
|
Total
n=646 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
118 Participants
n=39 Participants
|
16 Participants
n=29 Participants
|
134 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
432 Participants
n=39 Participants
|
80 Participants
n=29 Participants
|
512 Participants
n=60 Participants
|
|
Sex: Female, Male
Female
|
282 Participants
n=39 Participants
|
45 Participants
n=29 Participants
|
327 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
268 Participants
n=39 Participants
|
51 Participants
n=29 Participants
|
319 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
90 Participants
n=39 Participants
|
96 Participants
n=29 Participants
|
186 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
460 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
460 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
547 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
547 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
12 Participants
n=29 Participants
|
12 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
3 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
83 Participants
n=29 Participants
|
83 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Study Participation of One YearThe prevalence of ATTR cardiac amyloidosis was calculated from among the number of subjects within the cohort determined to be ATTR-CA positive. Determination of ATTR-CA was defined as significant myocardial retention of Tc-99 PYP. The prevalence is expressed as a percentage of total enrollment. ATTR-CA prevalence is reported for two different groups: Self-identified as Black, subjects with Heart Failure and Self-identified as non-Black, subjects with Heart Failure.
Outcome measures
| Measure |
Self-identified as Black, Subjects With Heart Failure
n=550 Participants
ATTR-CA prevalence, among subjects with heart failure who self-identified as Black, which was determined by 99mTc-PYP (or 99mTc-HDP) scintigraphy.
|
Self-identified as Non-Black, Subjects With Heart Failure
n=96 Participants
ATTR-CA prevalence, among subjects with heart failure who did not self-identify as Black, which was determined by 99mTc-PYP (or 99mTc-HDP) scintigraphy.
|
|---|---|---|
|
Prevalence of Transthyretin Cardiac Amyloidosis (ATTR-CA) in Cohort of Caribbean Hispanics and Blacks With Heart Failure (HF)
|
7.8 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Study Participation of One YearPopulation: Data is separately provided for the study population who were ≤75 years and those who were \>75 years old.
The prevalence of ATTR cardiac amyloidosis was calculated from among the number of subjects within the cohort determined to be ATTR-CA positive among participants ≤75 years or \>75 years enrolled in this study. Determination of ATTR was defined as significant myocardial retention of Tc-99 PYP. The prevalence is expressed as a percentage of total enrollment. ATTR-CA prevalence is reported for two different groups: Self-identified as Black, subjects with Heart Failure and Self-identified as non-Black, subjects with Heart Failure.
Outcome measures
| Measure |
Self-identified as Black, Subjects With Heart Failure
n=550 Participants
ATTR-CA prevalence, among subjects with heart failure who self-identified as Black, which was determined by 99mTc-PYP (or 99mTc-HDP) scintigraphy.
|
Self-identified as Non-Black, Subjects With Heart Failure
n=96 Participants
ATTR-CA prevalence, among subjects with heart failure who did not self-identify as Black, which was determined by 99mTc-PYP (or 99mTc-HDP) scintigraphy.
|
|---|---|---|
|
Age Distribution of ATTR Cardiac Amyloidosis
Subjects ≤75 years
|
3.42 percentage of participants
|
0 percentage of participants
|
|
Age Distribution of ATTR Cardiac Amyloidosis
Subjects >75 years
|
14.04 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Study Participation of One YearPopulation: Data is separately provided for the study population who were male and those who were female.
The prevalence of ATTR cardiac amyloidosis was calculated from among the number of subjects within the cohort determined to be ATTR-CA positive among male and female participants enrolled in this study. Determination of ATTR was defined as significant myocardial retention of Tc-99 PYP. The prevalence is expressed as a percentage of total enrollment. ATTR-CA prevalence is reported for two different groups: Self-identified as Black, subjects with Heart Failure and Self-identified as non-Black, subjects with Heart Failure.
Outcome measures
| Measure |
Self-identified as Black, Subjects With Heart Failure
n=550 Participants
ATTR-CA prevalence, among subjects with heart failure who self-identified as Black, which was determined by 99mTc-PYP (or 99mTc-HDP) scintigraphy.
|
Self-identified as Non-Black, Subjects With Heart Failure
n=96 Participants
ATTR-CA prevalence, among subjects with heart failure who did not self-identify as Black, which was determined by 99mTc-PYP (or 99mTc-HDP) scintigraphy.
|
|---|---|---|
|
Sex Distribution of ATTR Cardiac Amyloidosis
Percentage of female participants with ATTR
|
6 percentage of participants
|
0 percentage of participants
|
|
Sex Distribution of ATTR Cardiac Amyloidosis
Percentage of Male participants with ATTR
|
9.7 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Study Participation of One YearThe prevalence of ATTR cardiac amyloidosis was calculated from among the number of subjects within the cohort determined to be ATTR-CA positive among those self-identified as Hispanic, enrolled in this study. Determination of ATTR was defined as significant myocardial retention of Tc-99 PYP. The prevalence is expressed as a percentage of total enrollment. ATTR-CA prevalence is reported for two different groups: Self-identified as Black, subjects with Heart Failure and Self-identified as non-Black, subjects with Heart Failure.
Outcome measures
| Measure |
Self-identified as Black, Subjects With Heart Failure
n=90 Participants
ATTR-CA prevalence, among subjects with heart failure who self-identified as Black, which was determined by 99mTc-PYP (or 99mTc-HDP) scintigraphy.
|
Self-identified as Non-Black, Subjects With Heart Failure
n=96 Participants
ATTR-CA prevalence, among subjects with heart failure who did not self-identify as Black, which was determined by 99mTc-PYP (or 99mTc-HDP) scintigraphy.
|
|---|---|---|
|
Self-Identified Hispanic Ethnicity Distribution of ATTR Cardiac Amyloidosis.
|
4.4 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Study Participation of One YearThe prevalence of ATTR cardiac amyloidosis was calculated from among the number of subjects within the cohort determined to be ATTR-CA positive among those variant (v142i) and non-variant (wild-type) participants enrolled in this study. Determination of ATTR was defined as significant myocardial retention of Tc-99 PYP. The prevalence is expressed as a percentage of total enrollment. ATTR-CA prevalence is reported for two different groups: Self-identified as Black, subjects with Heart Failure and Self-identified as non-Black, subjects with Heart Failure.
Outcome measures
| Measure |
Self-identified as Black, Subjects With Heart Failure
n=550 Participants
ATTR-CA prevalence, among subjects with heart failure who self-identified as Black, which was determined by 99mTc-PYP (or 99mTc-HDP) scintigraphy.
|
Self-identified as Non-Black, Subjects With Heart Failure
n=96 Participants
ATTR-CA prevalence, among subjects with heart failure who did not self-identify as Black, which was determined by 99mTc-PYP (or 99mTc-HDP) scintigraphy.
|
|---|---|---|
|
ATTR Type Distribution of Cardiac Amyloidosis
Subjects without v142i variant
|
24 Participants
|
0 Participants
|
|
ATTR Type Distribution of Cardiac Amyloidosis
Subjects with v142i variant
|
19 Participants
|
0 Participants
|
Adverse Events
Self Identified as Black, Subjects With Heart Failure
Self Identified as Non-Black, Subjects With Heart Failure
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Self Identified as Black, Subjects With Heart Failure
n=550 participants at risk
Adverse event prevalence, among subjects with heart failure who self-identified as Black, according to description above.
|
Self Identified as Non-Black, Subjects With Heart Failure
n=96 participants at risk
Adverse event prevalence, among subjects with heart failure who self-identified as non-Black, according to description above.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.18%
1/550 • Number of events 1 • One Year
Only adverse events that met the specified criteria listed in the protocol were collected. The protocol states: "In accordance with 21 CFR 312.32(a), a suspected adverse reaction (SAR) means any adverse event for which there is a reasonable possibility that the drug caused the adverse event." Therefore only events adjudged to be related to PYP administration are listed.
|
0.00%
0/96 • One Year
Only adverse events that met the specified criteria listed in the protocol were collected. The protocol states: "In accordance with 21 CFR 312.32(a), a suspected adverse reaction (SAR) means any adverse event for which there is a reasonable possibility that the drug caused the adverse event." Therefore only events adjudged to be related to PYP administration are listed.
|
|
General disorders
Dizziness
|
0.18%
1/550 • Number of events 1 • One Year
Only adverse events that met the specified criteria listed in the protocol were collected. The protocol states: "In accordance with 21 CFR 312.32(a), a suspected adverse reaction (SAR) means any adverse event for which there is a reasonable possibility that the drug caused the adverse event." Therefore only events adjudged to be related to PYP administration are listed.
|
0.00%
0/96 • One Year
Only adverse events that met the specified criteria listed in the protocol were collected. The protocol states: "In accordance with 21 CFR 312.32(a), a suspected adverse reaction (SAR) means any adverse event for which there is a reasonable possibility that the drug caused the adverse event." Therefore only events adjudged to be related to PYP administration are listed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place