Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Global Prevalence of ATTR-CM in Participants With HFpEF
Global Prevalence of ATTR-CM in Participants With HFpEF

NCT04424914

TerminatedNA

Sponsor: Pfizer

Conditions: Transthyretin Amyloid Cardiomyopathy, Heart Failure With Preserved Ejection Fraction

Interventions: Scintigraphy

Countries: United States, Canada, France, Italy, Japan, Poland, Spain, United Kingdom

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 \[participants with heart failure with preserved ejection fraction (HFpEF)\].

Eligibility overview

Sex: ALL

Age: 60 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

   \-
Locations (51)
  • Fairhope, Alabama, United States
  • Huntsville, Alabama, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Ocala, Florida, United States
  • Hazel Crest, Illinois, United States
  • Oak Lawn, Illinois, United States
  • Topeka, Kansas, United States
  • Topeka, Kansas, United States
  • New Orleans, Louisiana, United States
  • Grand Rapids, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Tupelo, Mississippi, United States
  • Tupelo, Mississippi, United States
  • New York, New York, United States
  • Raleigh, North Carolina, United States
  • Jackson, Tennessee, United States
  • Spokane, Washington, United States
  • Ottawa, Ontario, Canada
  • Saint-Jean-sur-Richelieu, Quebec, Canada
  • Trois-Rivières, Quebec, Canada
  • Bron, France
  • Lyon, France
  • Nîmes, France
  • Toulouse, France
  • Villeurbanne, France
  • + 21 more on CT.gov