Screening for Cardiac Amyloidosis With Nuclear Imaging for Minority Populations

NCT03812172 | Completed Results FDA Drug

• 2 other identifiers: AAAS4054R01HL139671-01A1
• Study Type: observational
• Target: 646
• Locations: 1 country
• Sites: 4

Brief Summary

In this study, the investigators recruited a cohort of elderly Black and Hispanic patients with heart failure to define the number of patients who have cardiac amyloidosis by utilizing highly sensitive heart imaging and blood tests. The investigators also explored differences in genetics and sex as they relate to heart failure disease progression in cardiac amyloidosis.

Conditions

Amyloid Cardiomyopathy, Transthyretin-Related

Keywords

Heart Failure; Cardiac Amyloidosis; TTR mutation; Blacks; Hispanics; Aging

Outcome Measures

Primary Outcomes (5)

• Prevalence of Transthyretin Cardiac Amyloidosis (ATTR-CA) in Cohort of Caribbean Hispanics and Blacks With Heart Failure (HF)

  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.

  Study Participation of One Year

• Age Distribution of ATTR Cardiac Amyloidosis

  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.

  Study Participation of One Year

• Sex Distribution of ATTR Cardiac Amyloidosis

  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.

  Study Participation of One Year

• Self-Identified Hispanic Ethnicity Distribution of ATTR Cardiac Amyloidosis.

  The 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.

  Study Participation of One Year

• ATTR Type Distribution of Cardiac Amyloidosis

  The 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.

  Study Participation of One Year

Study Arms (1)

Blacks/Hispanics with Heart Failure

Blacks/Hispanics with heart failure due to transthyretin cardiac amyloidosis were identified by 99mTc-PYP (or 99mTc-HDP) scintigraphy. Those with transthyretin cardiac amyloidosis were further subtyped into those with a genetic cause (ATTRv) and those with a non-genetic cause (ATTRwt - wild type transthyretin cardiac amyloidosis).

Drug: 99mTc-PYP or 99m Tc-HDP

Interventions

99mTc-PYP or 99m Tc-HDP DRUG

10-25 mCi of 99mTc-PYP (or 99m Tc-HDP) was administered intravenously and imaging was performed after 3 hours.

Also known as: Technetium-99m-Pyrophosphate or Technetium-99m-HydroxyMethyleneDiphosphonate

Blacks/Hispanics with Heart Failure

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Blacks and Caribbean Hispanics with heart failure not primarily due to ischemic heart disease or valvular disease.

You may qualify if:

• Black or Hispanic of Caribbean origin.
• Age ≥ 60 years.
• Diagnosis of heart failure, confirmed by one of two methods:
• Modified criteria utilized by Rich et al. which include a history of acute pulmonary edema or the occurrence of at least two of the following that improved with diuretic therapy without another identifiable cause: dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, bilateral lower extremity edema or exertional fatigue, and
• National Health and Nutrition Examination Survey (NHANES) congestive heart failure (CHF) criteria with a score ≥3.
• Left ventricular septal OR inferolateral wall thickness ≥12 mm by echocardiography.
• Left ventricular Ejection fraction \>30% by echocardiography.
• Able to understand and sign the informed consent document after the nature of the study has been fully explained.

You may not qualify if:

• Primary amyloidosis (AL) or secondary amyloidosis (AA).
• Prior liver or heart transplantation.
• Active malignancy or non-amyloid disease with expected survival of less than 1 year.
• Heart failure, in the opinion of the investigator, primarily caused by severe left-sided valve disease. Note: if valve was repaired, subject may be considered as no longer with severe valve disease.Heart failure, in the opinion of the investigator, primarily caused by either valve disease or ischemic heart disease.
• Heart failure, in the opinion of the investigator, primarily caused by ischemic heart disease.
• Ventricular assist device or anticipated within the next 6 months.
• Impairment from stroke, injury or other medical disorder that precludes participation in the study.
• Disabling dementia or other mental or behavioral disease.
• Enrollment in a clinical trial not approved for co-enrollment.
• Expected use of continuous intravenous inotropic therapy in the next 6 months.
• High risk for non-adherence as determined by screening evaluation.
• Inability or unwillingness to comply with the study requirements.
• Chronic kidney disease with eGFR \<15 mL/min/1.73 m2 or ESRD.
• Weight \>350 lb.
• Nursing home resident.

Sponsors & Collaborators

• Mathew S. Maurer, MD: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Boston Medical Center: collaborator
• Harlem Hospital Center: collaborator
• The Scripps Research Institute: collaborator
• Yale University: collaborator

Study Sites (4)

Yale University/Yale New Haven Medical Center

New Haven, Connecticut, 06519, United States

Location

Boston Medical Center/Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Harlem Hospital

New York, New York, 10037, United States

Location

Related Publications (10)

• Maurer MS, Schwartz JH, Gundapaneni B, Elliott PM, Merlini G, Waddington-Cruz M, Kristen AV, Grogan M, Witteles R, Damy T, Drachman BM, Shah SJ, Hanna M, Judge DP, Barsdorf AI, Huber P, Patterson TA, Riley S, Schumacher J, Stewart M, Sultan MB, Rapezzi C; ATTR-ACT Study Investigators. Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018 Sep 13;379(11):1007-1016. doi: 10.1056/NEJMoa1805689. Epub 2018 Aug 27.

  PMID: 30145929 BACKGROUND

• Castano A, Haq M, Narotsky DL, Goldsmith J, Weinberg RL, Morgenstern R, Pozniakoff T, Ruberg FL, Miller EJ, Berk JL, Dispenzieri A, Grogan M, Johnson G, Bokhari S, Maurer MS. Multicenter Study of Planar Technetium 99m Pyrophosphate Cardiac Imaging: Predicting Survival for Patients With ATTR Cardiac Amyloidosis. JAMA Cardiol. 2016 Nov 1;1(8):880-889. doi: 10.1001/jamacardio.2016.2839.

  PMID: 27557400 BACKGROUND

• Gillmore JD, Maurer MS, Falk RH, Merlini G, Damy T, Dispenzieri A, Wechalekar AD, Berk JL, Quarta CC, Grogan M, Lachmann HJ, Bokhari S, Castano A, Dorbala S, Johnson GB, Glaudemans AW, Rezk T, Fontana M, Palladini G, Milani P, Guidalotti PL, Flatman K, Lane T, Vonberg FW, Whelan CJ, Moon JC, Ruberg FL, Miller EJ, Hutt DF, Hazenberg BP, Rapezzi C, Hawkins PN. Nonbiopsy Diagnosis of Cardiac Transthyretin Amyloidosis. Circulation. 2016 Jun 14;133(24):2404-12. doi: 10.1161/CIRCULATIONAHA.116.021612. Epub 2016 Apr 22.

  PMID: 27143678 BACKGROUND

• Ruberg FL, Maurer MS, Judge DP, Zeldenrust S, Skinner M, Kim AY, Falk RH, Cheung KN, Patel AR, Pano A, Packman J, Grogan DR. Prospective evaluation of the morbidity and mortality of wild-type and V122I mutant transthyretin amyloid cardiomyopathy: the Transthyretin Amyloidosis Cardiac Study (TRACS). Am Heart J. 2012 Aug;164(2):222-228.e1. doi: 10.1016/j.ahj.2012.04.015.

  PMID: 22877808 BACKGROUND

• Ruberg FL, Grogan M, Hanna M, Kelly JW, Maurer MS. Transthyretin Amyloid Cardiomyopathy: JACC State-of-the-Art Review. J Am Coll Cardiol. 2019 Jun 11;73(22):2872-2891. doi: 10.1016/j.jacc.2019.04.003.

  PMID: 31171094 BACKGROUND

• Maurer MS, Bokhari S, Damy T, Dorbala S, Drachman BM, Fontana M, Grogan M, Kristen AV, Lousada I, Nativi-Nicolau J, Cristina Quarta C, Rapezzi C, Ruberg FL, Witteles R, Merlini G. Expert Consensus Recommendations for the Suspicion and Diagnosis of Transthyretin Cardiac Amyloidosis. Circ Heart Fail. 2019 Sep;12(9):e006075. doi: 10.1161/CIRCHEARTFAILURE.119.006075. Epub 2019 Sep 4.

  PMID: 31480867 BACKGROUND

• Kittleson MM, Maurer MS, Ambardekar AV, Bullock-Palmer RP, Chang PP, Eisen HJ, Nair AP, Nativi-Nicolau J, Ruberg FL; American Heart Association Heart Failure and Transplantation Committee of the Council on Clinical Cardiology. Cardiac Amyloidosis: Evolving Diagnosis and Management: A Scientific Statement From the American Heart Association. Circulation. 2020 Jul 7;142(1):e7-e22. doi: 10.1161/CIR.0000000000000792. Epub 2020 Jun 1.

  PMID: 32476490 BACKGROUND

• Ruberg FL, Teruya S, Helmke S, Smiley DA, Fine D, Kurian D, Raiszadeh F, Prokaeva T, Spencer B, Wong S, Pandey S, Blaner WS, DeLuca A, Johnson LL, Kinkhabwala MP, Leb J, Mintz A, LaValley MP, Einstein AJ, Cohn E, Gallegos C, Murtagh G, Kelly JW, Miller EJ, Maurer MS. Transthyretin Cardiac Amyloidosis in Older Black and Hispanic Individuals With Heart Failure. JAMA Cardiol. 2025 Oct 1;10(10):1034-1043. doi: 10.1001/jamacardio.2025.2948.

  PMID: 40928765 DERIVED

• Madhani A, Sabogal N, Massillon D, Paul LD, Rodriguez C, Fine D, Helmke S, Winburn M, Kurian D, Raiszadeh F, Teruya S, Cohn E, Einstein AJ, Miller EJ, Connors LH, Maurer MS, Ruberg FL. Clinical Penetrance of the Transthyretin V122I Variant in Older Black Patients With Heart Failure: The SCAN-MP (Screening for Cardiac Amyloidosis With Nuclear Imaging in Minority Populations) Study. J Am Heart Assoc. 2023 Aug;12(15):e028973. doi: 10.1161/JAHA.122.028973. Epub 2023 Jul 24.

  PMID: 37486082 DERIVED

• Ruberg FL, Blaner WS, Chiuzan C, Connors LH, Einstein AJ, Fine D, Helmke S, Kurian D, Pandey S, Raiszadeh F, Rodriguez C, Sabogal N, Teruya S, Winburn M, Chung WK, Cohn E, Miller EJ, Kelly JW, Maurer MS. Design and Rationale the SCAN-MP (Screening for Cardiac Amyloidosis With Nuclear Imaging in Minority Populations) Study. J Am Heart Assoc. 2023 Apr 18;12(8):e028534. doi: 10.1161/JAHA.122.028534. Epub 2023 Apr 17.

  PMID: 37066788 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Participants in this study provided samples of blood which were analyzed for specific biomarkers and stored for possible future research.

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Heart Failure

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Mathew Maurer
• Organization: Columbia University Irving Medical Center

msm10@cumc.columbia.edu

2123058274

Study Officials

• Mathew S. Maurer, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Arnold and Arlene Goldstein Professor of Cardiology

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 23, 2019
• Study Start: May 15, 2019
• Primary Completion: June 12, 2024
• Study Completion: December 13, 2024
• Last Updated: November 19, 2025
• Results First Posted: November 19, 2025

Record last verified: 2025-11

Locations

US (4)