Global Prevalence of ATTR-CM in Participants With HFpEF

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NCT04424914

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transthyretin Amyloid Cardiomyopathy, Heart Failure With Preserved Ejection Fraction
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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 and biopsy (if Grade 1 scintigraphy).

5. NT-ProBNP ≥600 pg/ml.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Diagnosis of heart failure with reduced ejection fraction (HFrEF) (EF ≤40%).


2. Presence or history of ischemic heart disease affecting at least 1 of the main
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.


-

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Transthyretin Amyloid Cardiomyopathy, Heart Failure With Preserved Ejection FractionGlobal Prevalence of ATTR-CM in Participants With HFpEF
NCT04424914
ALL GENDERS
60 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Global Prevalence of ATTR-CM in Participants With HFpEF
Official Title  ICMJE GLOBAL PREVALENCE OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF)
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)].
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel 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 and if result is grade 1, will undergo a confirmatory endomyocardial biopsy.
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Transthyretin Amyloid Cardiomyopathy
  • Heart Failure With Preserved Ejection Fraction
Intervention  ICMJE Diagnostic Test: Scintigraphy
scintigraphy and confirmatory endomyocardial biopsy if needed
Study Arms  ICMJE
  • ATTR-CM positive
    Participants diagnosed with ATTR-CM by scintigraphy (and confirmatory biopsy if required).
    Intervention: Diagnostic Test: Scintigraphy
  • ATTR-CM negative
    Participants who are scintigraphy negative for ATTR-CM
    Intervention: Diagnostic Test: Scintigraphy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2020)		2500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 12, 2022
Estimated Primary Completion Date September 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 and biopsy (if Grade 1 scintigraphy).
  5. NT-ProBNP ?600 pg/ml.

Exclusion Criteria:

  1. Diagnosis of heart failure with reduced ejection fraction (HFrEF) (EF ?40%).
  2. Presence or history of ischemic heart disease affecting at least 1 of the main 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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04424914
Other Study ID Numbers  ICMJE B3461087
ATRIS ( Other Identifier: Alias Study Number )
HFpEF ATTR-CM prevalence study ( Other Identifier: Alias Study Number )
2020-002378-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP