Study on Pelacarsen for Slowing Calcific Aortic Valve Stenosis in Patients

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Calcific Aortic Valve Stenosis, a condition where the heart’s aortic valve becomes narrowed due to calcium buildup, making it harder for the heart to pump blood. The treatment being tested is called pelacarsen, also known by its code name TQJ230. Pelacarsen is an antisense oligonucleotide, which is a type of medication designed to lower levels of a specific protein in the blood called lipoprotein(a). This protein is linked to the progression of the disease.

The purpose of the study is to see if pelacarsen can slow down the worsening of calcific aortic valve stenosis. Participants in the study will receive either pelacarsen or a placebo, which looks like the treatment but does not contain the active medication. The study will last for about 36 months, during which participants will receive regular injections of the treatment or placebo. The effects of the treatment will be monitored through various tests, including echocardiography, which uses sound waves to create images of the heart, and computed tomography (CT), a type of imaging that provides detailed pictures of the heart’s structure.

Throughout the study, changes in the heart’s function and structure will be assessed to determine if pelacarsen is effective in slowing the disease’s progression. Participants will also have their lipoprotein(a) levels checked, and any side effects or health changes will be closely monitored to ensure safety. The study aims to provide valuable information on whether pelacarsen can be a beneficial treatment for people with calcific aortic valve stenosis.

1 randomization

Upon joining the study, participants are randomly assigned to receive either the medication pelacarsen (TQJ230) or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

2 medication administration

Participants receive the assigned treatment through subcutaneous injection. The medication is provided in a pre-filled syringe with a needle safety device. The dosage is 80 mg/0.8 mL for those receiving pelacarsen.

3 treatment duration

The treatment is administered regularly over a period of 36 months. The exact frequency of administration is determined by the study protocol.

4 monitoring and assessments

Throughout the study, participants undergo regular assessments to monitor the progression of calcific aortic valve stenosis. This includes measuring changes in peak aortic jet velocity and aortic valve calcium score using echocardiography and computed tomography, respectively.

5 safety evaluations

Safety is closely monitored by collecting data on any adverse events, serious adverse events, and changes in safety laboratory parameters and vital signs from the start to the end of the study.

6 study completion

The study concludes after 36 months of treatment. Final assessments are conducted to evaluate the overall impact of the treatment on the progression of the condition.

Who Can Join the Study?

  • Participants must be male or female and between 50 to 79 years old.
  • Participants need to have a Lipoprotein(a) level of 175 nmol/L or higher. Lipoprotein(a) is a type of fat in the blood.
  • Participants should have mild or moderate calcific aortic valve stenosis. This means the heart valve has some calcium buildup, causing it to narrow. It is measured by a test showing a peak aortic jet velocity between 2.5 and 3.5 meters per second.
  • At the time of joining the study, participants must be receiving the best possible treatment for any existing cardiovascular risk factors. This includes managing things like LDL cholesterol, diabetes, and high blood pressure according to local medical guidelines.

Who Cannot Join the Study?

  • Patients who have a history of severe allergic reactions to the study medication or its ingredients cannot participate.
  • Individuals with other serious heart conditions, apart from calcific aortic valve stenosis, are excluded.
  • Patients who have had a heart attack or stroke in the past six months are not eligible.
  • People with uncontrolled high blood pressure, which means their blood pressure is not well-managed with medication, cannot join the study.
  • Individuals with severe kidney disease, which affects how well the kidneys work, are excluded.
  • Patients with liver disease that affects liver function are not eligible.
  • Women who are pregnant or breastfeeding cannot participate in the trial.
  • Individuals who are currently participating in another clinical trial are excluded.
  • Patients who have a history of drug or alcohol abuse in the past year are not eligible.
  • People with any condition that the study doctors believe would make it unsafe for them to participate are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Stichting OLVG Amsterdam The Netherlands
ze:ro Praxen MVZ fuer Nierenerkrankungen und Bluthochdruck GmbH Mannheim Mannheim Germany
Imed19-Privat Vienna Austria
Medical University Of Vienna Vienna Austria
Sydvestjysk Sygehus Esbjerg Denmark
Hospital Universitario De Salamanca Salamanca Spain
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Algemeen Stedelijk Ziekenhuis Campus Aalst Aalst Belgium

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Klinikum Oldenburg AöR Oldenburg In Holstein Germany
Hopital Saint Antoine Paris France
Hopitaux Universitaires Pitie Salpetriere Paris France
Centro Cardiologico Monzino S.p.A. Milan Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital Universitario 12 De Octubre Madrid Spain
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Algemeen Ziekenhuis Delta Roeselare Belgium
Hospital San Pedro De Alcantara Caceres Spain
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Kardiopraxis Schirmer Kaiserslautern Germany
Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH Dresden Germany
Ospedale Galeazzi S.p.A. Milan Italy
Herzzentrum Leipzig GmbH Leipzig Germany
Edumed s.r.o. Nachod Czechia
Azienda Ospedaliera di Padova Padua Italy
ClinPhenomics CVC GmbH Frankfurt Germany
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Deutsches Herzzentrum Muenchen Des Freistaates Bayern Klinik An Der Technischen Universitaet Muenchen Munich Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Universita’ Politecnica Delle Marche Ancona Italy
Istituto Neurologico Mediterraneo Neuromed S.p.A. Pozzilli Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Klinik Favoriten Vienna Austria
Region Midtjylland Aarhus Denmark
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Azienda Ospedaliera Sant Anna E San Sebastiano Di Caserta Caserta Italy
Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA Valencia Spain
Centre Hospitalier Universitaire De Rennes Rennes France
Ziekenhuis Oost Limburg Genk Belgium
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Universita’ Degli Studi Di Ferrara Ferrara Italy
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Praxis fuer Innere Medizin Munster Germany
Region Sjaelland Holbæk Denmark
Udgqmnopqn Mioegex Chvmwi Hwaowfmwvejeppvou Hamburg Germany
Uyjpyzduuuihscswpamzw Eykia Agt Essen Germany
Incycieog Fxf Ctwdnlhj Aqa Eyolzzpmdqhg Muoxmeto Prague Czechia
Hotrxldg Houcjkgb Hvidovre Denmark
Kqpfwxel Wndghqmvzkvktche Ghlo Ahaus Germany
Sjqqi Meqhx Dpwox Axixph Hbqhrafv Pordenone Italy
Fjourjuh nbthtmyyj Mhjfm a Hhjvrdy Prague Czechia
Crzhpd Hllzhlvjadv Uggauvjkvgeal Di Dgbnv Dijon France
Elvwweb Uxzrsspgflyg Mcbrxyb Colovmf Rtiaxhsmf (bijuema Mmz Rotterdam The Netherlands
Aljknyplm Ugz Amsterdam The Netherlands
Abwtgrt Uxlmp Somsvrvpo Lgkbur Db Bnukely Bologna Italy
Gxsf Srwwq Pkhbftdjr Clgocjz Sarb Cascais Portugal
Abwaepm Omulokprwjd Pkfy Gezahzoq Xmdzx Bergamo Italy
Fpwavedcn Ptwz Le Ixjcxublegwaa Bmaobujkp Drt Haifotzi Uwiqtmcqkmadm Lz Pxk Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
03.06.2024
Belgium Belgium
Recruiting
03.06.2024
Czechia Czechia
Recruiting
03.06.2024
Denmark Denmark
Recruiting
03.06.2024
France France
Recruiting
03.06.2024
Germany Germany
Recruiting
03.06.2024
Italy Italy
Recruiting
03.06.2024
Portugal Portugal
Recruiting
03.06.2024
Spain Spain
Recruiting
03.06.2024
The Netherlands The Netherlands
Recruiting
03.06.2024

Trial locations

Investigated drugs:

Pelacarsen (TQJ230) is a medication being studied for its ability to lower lipoprotein(a) levels in the blood. The trial aims to see if reducing lipoprotein(a) can slow down the progression of calcific aortic valve stenosis, a condition where the heart valve becomes narrowed due to calcium buildup. The effectiveness of pelacarsen is being measured by changes in heart valve function and calcium deposits over a period of 36 months.

Investigated diseases:

Calcific Aortic Valve Stenosis – This disease involves the narrowing of the aortic valve in the heart due to calcium buildup on the valve leaflets. Over time, the valve becomes stiff and less able to open fully, which restricts blood flow from the heart into the aorta and onward to the rest of the body. As the condition progresses, the heart must work harder to pump blood through the narrowed valve, which can lead to symptoms such as chest pain, fatigue, and shortness of breath. The disease typically develops slowly over many years and is more common in older adults. As the stenosis worsens, it can significantly impact heart function and overall circulation. Regular monitoring and evaluation are important to assess the progression of the disease.

Trial ID:
2022-502135-19-00
Protocol code:
CTQJ230A12203
NCT ID:
NCT05646381
Trial Phase:
Therapeutic exploratory (Phase II)

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