Heart Failure Clinical Trial
Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy
Summary
This is a multicenter, randomized, placebo-controlled, 2-part study to evaluate the safety and efficacy of AT-001 in adult patients (N=675) with Diabetic Cardiomyopathy at high risk of progression to overt heart failure.
Full Description
The study consists of two consecutive parts: Part A and Part B. Part A will evaluate the safety and efficacy of two doses of AT-001 vs placebo. The primary objective of Part A is to demonstrate that AT-001 improves or prevents the decline of functional capacity in patients with Diabetic Cardiomyopathy. Part B is an extension of at least 12 months that will evaluate the safety and efficacy of chronic administration of AT-001 vs placebo in the same patients who had previously been evaluated in Part A. Assessments in Part B will include safety endpoints and exploratory clinical efficacy endpoints, i.e. death and hospitalization due to a cardiac event.
Eligibility Criteria
Inclusion Criteria:
Type 2 Diabetes Mellitus
Diabetic cardiomyopathy
Peak VO2 < 75% of predicted normal value based on age and gender
Exclusion Criteria:
Prior diagnosis or signs/symptoms of overt/symptomatic heart failure / stage C heart failure
Prior echocardiogrphic measurement of ejection fraction (EF) < 40%
Prior acute coronary syndrome (ACS), coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), coronary artery disease (CAD) or stroke
Severe or moderate cardiac valve disease requiring intervention
Clinically significant arrhythmia
Prior diagnosis of congenital, infective, toxic, infiltrative, post-partum, or hypertrophic cardiomyopathy
Blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic) at screening
HbA1c >8.5% at screening
Severe disease that would impact the performance of a cardio-pulmonary exercise test
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There are 75 Locations for this study
Beverly Hills California, 90211, United States
La Jolla California, 92093, United States
Lincoln California, 95648, United States
Orange California, 92868, United States
Tarzana California, 91356, United States
Torrance California, 90509, United States
Cooper City Florida, 33024, United States
Hialeah Florida, 33016, United States
Pembroke Pines Florida, 33024, United States
Port Orange Florida, 32127, United States
Peoria Illinois, 61602, United States
Boston Massachusetts, 02115, United States
Jackson Mississippi, 39216, United States
Saint Louis Missouri, 63136, United States
Bronx New York, 10455, United States
Bronx New York, 10467, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43215, United States
Oklahoma City Oklahoma, 73135, United States
Greer South Carolina, 29651, United States
Greer South Carolina, 29651, United States
Kingsport Tennessee, 37660, United States
Dallas Texas, 75230, United States
Dallas Texas, 75235, United States
Dallas Texas, 75390, United States
Houston Texas, 77040, United States
Houston Texas, 77074, United States
Lampasas Texas, 76550, United States
Chermside Queensland, 4032, Australia
Milton Queensland, 4064, Australia
Taringa Queensland, 4068, Australia
Hobart Tasmania, 7001, Australia
Geelong Victoria, 3220, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3004, Australia
Calgary Alberta, T2V 4, Canada
Vancouver British Columbia, V5Y 3, Canada
Brampton Ontario, L6S 0, Canada
Concord Ontario, L4K 4, Canada
Etobicoke Ontario, M9R 4, Canada
London Ontario, N6G 2, Canada
Toronto Ontario, M4G 3, Canada
Chicoutimi Quebec, G7H 7, Canada
Québec Quebec, G1V 4, Canada
Jaroměř , 55101, Czechia
Pardubice , 532 0, Czechia
Praha , 128 0, Czechia
Bondy , 93140, France
Créteil , 94000, France
Nantes , 44093, France
Valenciennes , 59322, France
Frankfurt (Oder) Brandenburg, 15236, Germany
Bad Oeynhausen North Rhine Westphalia, 32545, Germany
Dresden Saxony, 01277, Germany
Berlin , 10787, Germany
Elsterwerda , 04910, Germany
Sha Tin , , Hong Kong
Sha Tin , , Hong Kong
Wrocław Borowska, 50-55, Poland
Białystok , 15-43, Poland
Kraków , 31-50, Poland
Kraków , 31-52, Poland
Poznań , 61-65, Poland
Radom , 26-60, Poland
Rzeszów , 35-00, Poland
Wrocław , 50-98, Poland
Åódź , 90-30, Poland
Badalona Barcelona, 08916, Spain
El Palmar Murcia, 30120, Spain
A Coruña , 15001, Spain
Barcelona , 08041, Spain
Córdoba , 14004, Spain
Sevilla , 41009, Spain
Valencia , 46010, Spain
Dundee , DD1 9, United Kingdom
Glasgow , G20 0, United Kingdom
Leicester , LE3 9, United Kingdom
London , EC1M , United Kingdom
Manchester , M23 9, United Kingdom
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