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Global Prevalence of ATTR-CM in Participants With HFpEF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04424914
Recruitment Status : Active, not recruiting
First Posted : June 11, 2020
Last Update Posted : May 18, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This study is a global, multi-center study designed to estimate the global prevalence of transthyretin amyloid cardiomyopathy (ATTR-CM) within a clinically at risk population [participants with heart failure with preserved ejection fraction (HFpEF)].

Condition or disease Intervention/treatment Phase
Transthyretin Amyloid Cardiomyopathy Heart Failure With Preserved Ejection Fraction Diagnostic Test: Scintigraphy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: To determine global prevalence of transthyretin amyloid cardiomyopathy in participants diagnosed with heart failure with preserved ejection fraction. No study treatment will be dispensed however, participants will undergo scintigraphy.
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: GLOBAL PREVALENCE OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF)
Actual Study Start Date : December 30, 2020
Estimated Primary Completion Date : June 2, 2023
Estimated Study Completion Date : June 2, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
ATTR-CM positive
Participants diagnosed with ATTR-CM by scintigraphy
 Diagnostic Test: Scintigraphy
scintigraphy
ATTR-CM negative
Participants who are scintigraphy negative for ATTR-CM
 Diagnostic Test: Scintigraphy
scintigraphy


Outcome Measures
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Primary Outcome Measures :
  1. Estimate of global prevalence of ATTR-CM in HFpEF patients. [ Time Frame: Visit 1(baseline) through Follow-Up Visit 1 (Day 44) ]
    Includes participants not previously diagnosed with ATTR-CM but found to be positive by scintigraphy at Visit 1 (or subsequent biopsy if grade 1).


Secondary Outcome Measures :
  1. Estimate of prevalence of ATTR-CM within region, age and gender [ Time Frame: Visit 1(baseline) through Follow-Up Visit 1 (Day 44) ]
    Includes participants not previously diagnosed with ATTR-CM but found to be positive by scintigraphy at Visit 1 (or subsequent biopsy if grade 1).

  2. Prevalence of patients diagnosed ATTR-CM on study with WT and hereditary forms among patients diagnosed with ATTR CM [ Time Frame: Visit 1(baseline) through Follow-Up Visit 1 (Day 44) ]
  3. New York Heart Association (NYHA) Classification of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM [ Time Frame: Visit 1(baseline) through Follow-Up Visit 1 (Day 44) ]
  4. Nt-proBNP results of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM [ Time Frame: Visit 1(baseline) through Follow-Up Visit 1 (Day 44) ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Medical history of heart failure (HF) with:

    1. At least 1 episode with clinical evidence of HF (without hospitalization) by signs or symptoms of volume overload or elevated intracardiac pressures that required/requires treatment with a diuretic for improvement; OR
    2. 1 prior hospitalization for HF.
  2. Left ventricular ejection fraction (LVEF) >40%.
  3. End-diastolic interventricular septal wall thickness (IVST) ≥12 mm.
  4. Willing and able to undergo scintigraphy.

Exclusion Criteria:

  1. Diagnosis of heart failure with reduced ejection fraction (HFrEF) (EF ≤40%).
  2. Prior clinical history of myocardial infarction, CABG or multi-vessel obstructive coronary disease (>50% stenosis of ≥2 epicardial coronary arteries).
  3. Presence or history of any severe valvular heart disease (obstructive or regurgitant).
  4. A confirmed diagnosis of a non-amyloid infiltrative cardiomyopathy (ie, cardiac sarcoidosis, hemochromatosis), muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy with known genetic etiology, or known pericardial constriction.

  5. Any type of diagnosed amyloidosis (eg, amyloid A amyloidosis, primary [light chain] amyloidosis) or prior diagnosis of ATTR-CM.

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04424914


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04424914    
Other Study ID Numbers: B3461087
HFpEF ATTR-CM prevalence study ( Other Identifier: Alias Study Number )
2020-002378-29 ( EudraCT Number )
ATTR-POP ( Other Identifier: Alias Study Number )
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: May 18, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
prevalence
transthyretin amyloid
ATTR-CM
HFpEF
scintigraphy
Additional relevant MeSH terms:
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Heart Failure
Cardiomyopathies
Amyloidosis
Heart Diseases
 Cardiovascular Diseases
Proteostasis Deficiencies
Metabolic Diseases