CLEOPATTRA: Effects of NNC6019-0001 Versus Placebo on Cardiovascular Outcomes in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Novo Nordisk A/S

Summary

This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Male or female. 2. Age 18 years or above at the time of signing the informed consent. 3. Have an established diagnosis of ATTR-CM (wild-type ATTR \[ATTRwt\] or variant ATTR \[ATTRv\]), with cardiac amyloid infiltration, increased left ventricular (LV) wall thickness, and HF. Note: Target ATTRv recruitment is approximately 15 percent of the study population. a. Cardiac amyloid infiltration demonstrated by: i. Cardiac biopsy positive for TTR amyloid, OR ii. Grade 2 or 3 cardiac uptake at pyrophosphate (PYP)/diphosphono-1,2-propanodicarboxylic acid (DPD)/ hydroxyme…

Locations (297)

Mayo Clinic Hospital
Phoenix, Arizona
University of California San Diego (UCSD) - Sulpizio Cardiovascular Center (SCVC)
La Jolla, California
Keck School of Medicine USC - Healthcare Consultation Center 2 (HCCII)
Los Angeles, California
Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California
UCI Medical Center
Orange, California
Profound Research LLC at Southern California Heart Specialists
Pasadena, California

Summary

Eligibility

Interventions

Locations (297)