A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis
- Conditions
- Transthyretin Amyloid Cardiomyopathy (ATTR CM)
- Interventions
- Registration Number
- NCT06260709
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Completed study intervention in NN6019-4940 and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit 16.
- Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit.
- A prior solid organ transplant.
- Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening.
- Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response.
- Body weight greater than (>) 120 kilograms (kg) (264.6 pounds [lb]) at screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NNC6019-0001 NNC6019-0001 Participants will receive NNC6019-0001 intravenously every 4 weeks added to the standard of care until Week 140.
- Primary Outcome Measures
Name Time Method Number of Treatment Emergent Adverse Events From baseline (week 0) up to visit 39 (week 156) Measured as events.
- Secondary Outcome Measures
Name Time Method Change in Global Longitudinal Strain (GLS) on Echocardiography From baseline (week 0) to visit 28 (week 104) Measured in percentage-points.
Change in Troponin I From baseline (week 0) to visit 28 (week 104) Measured in nanogram per milliliter (ng/mL).
Change in Myocardial Extracellular Volume (ECV) From baseline (week 0) to visit 28 (week 104) Measured in percentage-points.
Change in N-terminal-pro brain natriuretic peptide (NT-proBNP) From baseline (week 0) to visit 28 (week 104) Measured in percentage.
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) From baseline (week 0) to visit 28 (week 104) The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. Measured in score on a scale.
Change in 6-Minute Walk Test (6MWT) From baseline (week 0) to visit 28 (week 104) Measured in meters.
Trial Locations
- Locations (32)
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Cedars-Sinai Medical Center_Los Angeles
🇺🇸Los Angeles, California, United States
Stanford Hlth Cre-Boswell Clin
🇺🇸Stanford, California, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
NW Univ-Bluhm Cardiovasc Inst
🇺🇸Evanston, Illinois, United States
Univ of MD Schl of Med
🇺🇸Baltimore, Maryland, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
University of Calgary_Cardiology
🇨🇦Calgary, Alberta, Canada
Ctr for Cardiovascular Innovation
🇨🇦Vancouver, British Columbia, Canada
II. interni klinika VFN - Kardiologie a angiologie
🇨🇿Praha 2, Czechia
Scroll for more (22 remaining)Mayo Clinic Arizona🇺🇸Phoenix, Arizona, United States