Trial Search Results

Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:


Stanford Investigator(s):


  • Drug: Tafamidis
  • Drug: Tafamidis
  • Drug: Placebo


Phase 3


Inclusion Criteria:

   - Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or
   clinical evidence of HF (without hospitalization) manifested by signs or symptoms of
   volume overload or elevated intracardiac pressures (e.g., elevated jugular venous
   pressure, shortness of breath or signs of pulmonary congestion on x-ray or
   auscultation, peripheral edema) that required/requires treatment with a diuretic for

   - Evidence of cardiac involvement by echocardiography with an end-diastolic
   interventricular septal wall thickness > 12 mm,

   - Presence of amyloid deposits in biopsy tissue and presence of a variant TTR genotype
   and/or TTR precursor protein identification by immunohistochemistry, scintigraphy or
   mass spectrometry

Exclusion Criteria:

   - A New York Heart Association (NYHA) classification of IV.

   - Presence of primary (light chain) amyloidosis.

   - Prior liver or heart transplantation or implanted cardiac mechanical assist device.

Ages Eligible for Study

18 Years - 90 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ed Finn
Not Recruiting