A research study evaluating if Pelacarsen slows the progression of Calcific Aortic Valve Stenosis

• Research type

  Research Study

• Full title

  A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein(a) lowering with pelacarsen (TQJ230) on the progression of calcific aortic valve stenosis [Lp(a)FRONTIERS CAVS]

• IRAS ID

  1005828

• Contact name

  Clement Dubos

• Contact email

  clement.dubos@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Clinicaltrials.gov Identifier

  NCT05646381

• Research summary

  Calcific aortic valve stenosis (CAVS) is the most frequent form of valvular heart disease in developed countries which is increasing as the general population live longer. CAVS is associated with the the progressive remodeling and thickening of the aortic valves in the heart, that over years leads to complications with how the heart functions. As of today, there is no medicine that slows the progression of CAVS.

  The purpose of this research study is to determine if the study treatment called pelacarsen (TQJ230), which lowers the body’s lipoprotein(a) production, is safe and can slow down the progression of CAVS when compared to a placebo (a treatment with no active ingredients). Pelacarsen is a medicine that has not yet been approved for the treatment of people with elevated Lp(a). Around 502 participants aged 50 years or older, with mild to moderate CAVS will take part at hospital research sites around the world and have subcutaneous (under the skin) injections, once per month for 3 years. Participants will be given a study treatment that is either:
  1. Pelacarsen injections. Participants have a one in two possibility (50% chance) of getting this treatment; or
  2. Placebo injections. Participants have a one in two possibility (50% chance) of getting placebo, which has no active ingredients.

  Participants will visit hospital research sites every 3 months to receive study treatment and health checks which include, physical exams, blood pressure measurements, donating blood/urine samples for safety and efficacy analysis, completing questionnaires about general health and any side effects. Participants will also have heart monitoring assessments that include electrocardiography (“ECG”), echocardiography (“Echo”) and cardiac computed tomography scans (“CCT”) throughout the research study.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  23/LO/0146

• Date of REC Opinion

  29 Aug 2023

• REC opinion

  Further Information Favourable Opinion