N/A
Completed N=812
Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology
Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Source: ClinicalTrials.gov NCT03842163 ↗
Enrolled (actual)
812
Serious AEs
—
Results posted
Feb 2024
Primary outcomePrimary: Percentage of Participants With Cardiac Fixation at the Radionuclide Bone Scintigraphy and/or Single Photon Emission Computed Tomography (SPECT): FAS1 — 32.0 Percentage of participants
Summary
The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among patients admitted due to Left Ventricular Hypertrophy (LVH) >15mm of unknown etiology by using a 99mTc-tracer scintigraphy based protocol
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Cardiac Fixation at the Radionuclide Bone Scintigraphy and/or Single Photon Emission Computed Tomography (SPECT): FAS1 |
32.0 | — |
| SECONDARY Percentage of Participants With Transthyretin Amyloid (ATTR): FAS 1 |
17.9 | — |
| SECONDARY Percentage of Participants With ATTR or With Suspicion of Monoclonal Gammopathy of Undetermined Significance (MGUS) / Light Chain Amyloidosis (AL): FAS 1 |
25.2 | — |
| SECONDARY Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 2 (FAS 2) |
6.5 | — |
| SECONDARY Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 3 (FAS 3) |
6.9 | — |
| SECONDARY Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.1 |
8.7 | — |
| SECONDARY Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.2 |
3.7 | — |
| SECONDARY Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 2 |
93.5 | — |
| SECONDARY Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3 |
93.1 | — |
| SECONDARY Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.1 |
91.3 | — |
| SECONDARY Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.2 |
96.3 | — |
| SECONDARY Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 2 |
13 | — |
| SECONDARY Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3 |
13 | — |
| SECONDARY Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.1 |
11 | — |
| SECONDARY Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.2 |
2 | — |
| SECONDARY Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 1 |
17.1 | — |
| SECONDARY Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 2 |
11.8 | — |
| SECONDARY Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3 |
9.6 | — |
| SECONDARY Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3.1 |
10.9 | — |
| SECONDARY Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3.2 |
7.1 | — |
| SECONDARY Percentage of Participants With Senso-Motor Polyneuropathy: FAS 2 |
80.0 | — |
| SECONDARY Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3 |
86.1 | — |
| SECONDARY Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.1 |
89.8 | — |
| SECONDARY Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.2 |
85.7 | — |
| SECONDARY Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 2 |
48.6 | — |
| SECONDARY Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3 |
54.8 | — |
| SECONDARY Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.1 |
60.6 | — |
| SECONDARY Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.2 |
48.2 | — |
| SECONDARY Percentage of Participants With Autonomic Dysfunction: FAS 2 |
55.9 | — |
| SECONDARY Percentage of Participants With Autonomic Dysfunction: FAS 3 |
58.7 | — |
| SECONDARY Percentage of Participants With Autonomic Dysfunction: FAS 3.1 |
61.3 | — |
| SECONDARY Percentage of Participants With Autonomic Dysfunction: FAS 3.2 |
57.1 | — |
| SECONDARY Percentage of Participants With Cardiological Manifestations: FAS 2 |
98.0 | — |
| SECONDARY Percentage of Participants With Cardiological Manifestations: FAS 3 |
98.1 | — |
| SECONDARY Percentage of Participants With Cardiological Manifestations: FAS 3.1 |
97.8 | — |
| SECONDARY Percentage of Participants With Cardiological Manifestations: FAS 3.2 |
98.2 | — |
| SECONDARY Percentage of Participants With Laboratory Abnormalities: FAS 2 |
37.6; 30.2; 62.9; 81.2; 3.7 | — |
| SECONDARY Percentage of Participants With Laboratory Abnormalities: FAS 3 |
42.3; 33.2; 69.7; 88.9; 3.8 | — |
| SECONDARY Percentage of Participants With Laboratory Abnormalities: FAS 3.1 |
34.3; 34.3; 68.6; 90.5; 4.4 | — |
| SECONDARY Percentage of Participants With Laboratory Abnormalities: FAS 3.2 |
58.9; 35.7; 89.3; 98.2; 1.8 | — |
| SECONDARY Number of Participants According to Presence of Neurological Red Flag: FAS1 |
143; 623 | — |
| SECONDARY Number of Participants According to Presence of Neurological Red Flag: FAS 2 |
142; 103 | — |
| SECONDARY Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1 |
43; 3; 5; 16; 8 | — |
| SECONDARY Cardiological Assessments - Blood Pressure: FAS 2 |
75.6; 132.5 | — |
| SECONDARY Cardiological Assessments - Blood Pressure: FAS 3 |
74.6; 131.0 | — |
| SECONDARY Cardiological Assessments - Blood Pressure: FAS 3.1 |
75.6; 130.9 | — |
| SECONDARY Cardiological Assessments - Blood Pressure: FAS 3.2 |
74.2; 131.9 | — |
| SECONDARY Number of Participants According to History of Clinical Parameters at Baseline: FAS 2 |
78; 167; 89; 156; 184; 61 | — |
| SECONDARY Number of Participants According to History of Clinical Parameters at Baseline: FAS 3 |
77; 131; 88; 120; 162; 46 | — |
| SECONDARY Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1 |
49; 88; 57; 80; 112; 25 | — |
| SECONDARY Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2 |
19; 37; 22; 34; 43; 13 | — |
| SECONDARY Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2 |
50; 130; 57; 7; 1 | — |
| SECONDARY Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3 |
45; 112; 45; 5; 1 | — |
| SECONDARY Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1 |
34; 69; 30; 3; 1 | — |
| SECONDARY Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.2 |
5; 38; 11; 2 | — |
| SECONDARY Number of Participants With Atrial Fibrillation Assessment: FAS 2 |
120; 90; 35 | — |
| SECONDARY Number of Participants With Atrial Fibrillation Assessment: FAS 3 |
105; 78; 25 | — |
| SECONDARY Number of Participants With Atrial Fibrillation Assessment: FAS 3.1 |
65; 52; 20 | — |
| SECONDARY Number of Participants With Atrial Fibrillation Assessment: FAS 3.2 |
28; 23; 5 | — |
| SECONDARY Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2 |
30; 215; 0; 245 | — |
| SECONDARY Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3 |
30; 178; 0; 208 | — |
| SECONDARY Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.1 |
20; 117; 0; 137 | — |
| SECONDARY Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.2 |
7; 49; 0; 56 | — |
| SECONDARY Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 2 |
11; 55 | — |
| SECONDARY Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3 |
7; 50 | — |
| SECONDARY Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.1 |
6; 33 | — |
| SECONDARY Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.2 |
0; 13 | — |
| SECONDARY Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 2 |
217; 18 | — |
| SECONDARY Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3 |
182; 18 | — |
| SECONDARY Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.1 |
122; 10 | — |
| SECONDARY Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.2 |
49; 6 | — |
| SECONDARY Heart Rate Parameter for Participants Without Paced: FAS 2 |
73.3 | — |
| SECONDARY Heart Rate Parameter for Participants Without Paced: FAS 3 |
73.2 | — |
| SECONDARY Heart Rate Parameter for Participants Without Paced: FAS 3.1 |
73.4 | — |
| SECONDARY Heart Rate Parameter for Participants Without Paced: FAS 3.2 |
72.7 | — |
| SECONDARY Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 2 |
86; 135; 6 | — |
| SECONDARY Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3 |
72; 114; 4 | — |
| SECONDARY Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.1 |
51; 73; 3 | — |
| SECONDARY Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.2 |
18; 32; 0 | — |
| SECONDARY Sokolow Index: FAS 2 |
19.1 | — |
| SECONDARY Sokolow Index: FAS 3 |
18.7 | — |
| SECONDARY Sokolow Index: FAS 3.1 |
19.8 | — |
| SECONDARY Sokolow Index: FAS 3.2 |
16.5 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF): FAS 2 |
55.0 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF): FAS 3 |
55.2 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF): FAS 3.1 |
55.7 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF): FAS 3.2 |
53.9 | — |
| SECONDARY Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 2 |
215; 26 | — |
| SECONDARY Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3 |
183; 22 | — |
| SECONDARY Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.1 |
119; 17 | — |
| SECONDARY Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.2 |
51; 5 | — |
| SECONDARY Number of Participants Categorized According to Perseverance of Strain Apical: FAS 2 |
28; 62 | — |
| SECONDARY Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3 |
26; 60 | — |
| SECONDARY Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.1 |
16; 46 | — |
| SECONDARY Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.2 |
8; 12 | — |
| SECONDARY LV End Diastolic Diameter: FAS 2 |
43.3 | — |
| SECONDARY LV End Diastolic Diameter: FAS 3 |
43.2 | — |
| SECONDARY LV End Diastolic Diameter: FAS 3.1 |
43.2 | — |
| SECONDARY LV End Diastolic Diameter: FAS 3.2 |
44.4 | — |
| SECONDARY Maximum Wall Thickness: FAS 2 |
17.4 | — |
| SECONDARY Maximum Wall Thickness: FAS 3 |
17.5 | — |
| SECONDARY Maximum Wall Thickness: FAS 3.1 |
17.9 | — |
| SECONDARY Maximum Wall Thickness: FAS 3.2 |
16.9 | — |
| SECONDARY Number of Participants According to Type of Hypertrophic Pattern: FAS 2 |
6; 179; 47; 8 | — |
| SECONDARY Number of Participants According to Type of Hypertrophic Pattern: FAS 3 |
4; 159; 37; 4 | — |
| SECONDARY Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1 |
1; 105; 27; 2 | — |
| SECONDARY Number of Participants According to Type of Hypertrophic Pattern: FAS 3.2 |
2; 46; 7; 1 | — |
| SECONDARY LV Mass Index (LVMI): FAS 2 |
172.7 | — |
| SECONDARY LV Mass Index (LVMI): FAS 3 |
177.0 | — |
| SECONDARY LV Mass Index (LVMI): FAS 3.1 |
177.0 | — |
| SECONDARY LV Mass Index (LVMI): FAS 3.2 |
185.5 | — |
| SECONDARY Aortic Valvular Stenosis - Aortic Valve Area: FAS 2 |
2.3 | — |
| SECONDARY Aortic Valvular Stenosis - Aortic Valve Area: FAS 3 |
2.2 | — |
| SECONDARY Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.1 |
2.3 | — |
| SECONDARY Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.2 |
2.0 | — |
Eligibility Criteria
Inclusion criteria
- Patient signed inform consent.
- Males and Females.
- Age ≥50 years.
- Left ventricular hypertrophy (LVH) defined as end-diastolic LV maximum wall thickness (MWT) ≥15mm in Echocardiogram.
- Plan to undergo or recently underwent radionuclide bone scintigraphy and/or SPECT with any of the following radio labelled tracers: 99mTc-DPD or 99mTc-PYP or 99mTc-HMDP.
Exclusion criteria
- Etiological diagnosis explaining the LVH (p.e. Sarcomeric HCM, Myeloma, Fabry disease, Sarcoidosis, Any type of amyloidosis (AA, AL, TTR)
- Severe aortic stenosis defined as aortic valve area (AVA) < 1.0 cm2
Data sourced from ClinicalTrials.gov (NCT03842163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.