A Research Study Comparing CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy

Официальное название

Phase 2, Multicentre, Randomised, Double-blind, Placebo-controlled Safety and Efficacy Study of CDR132L on Reverse Cardiac Remodelling in Participants With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy

Обзор

This study will look into how CDR132L (a potential new medicine) works on the structure and function of the heart in people living with heart failure. Participants will either get CDR132L or placebo (a medicine which has no effect on the body), which treatment the participants get is decided by chance. The study will last for about 60 weeks.

Вмешательства

• Препарат CDR132L
  Administered intravenous infusion of CDR132L once every 4 weeks for 48 weeks.
• Препарат Placebo
  Administered intravenous infusion of placebo once every 4 weeks for 48 weeks.

Первичные конечные точки

• Main Phase: Change in normalised microRNA-132-3p (miR-132) [Срок оценки: From baseline to week 24]

Вторичные конечные точки (3)

• Main Phase: Change in composite Z-score based on the 3 outcome measures: LVEDVi; LVESVi; NT-proBNP [Срок оценки: From baseline to week 24]
• Main Phase: Number of adverse events [Срок оценки: From baseline to week 24]
• Extension Phase: Number of adverse events [Срок оценки: From baseline to week 60]

Критерии участия

Критерии включения

• Age 40-84 years (both inclusive) at the time of signing the informed consent.
• Documented symptomatic heart failure (HF) diagnosed greater than or equal to (≥) 180 days prior to screening with at least weekly need for oral diuretic treatment, and New York Heart Association class II-III at screening.
• Clinically stable and on optimized doses and unchanged drug classes of guideline-directed HF therapy ≥ 45 days prior to randomisation.
• Left ventricular ejection fraction (LVEF) less than (<) 50 percent (%) as assessed by echocardiography at screening, measured by central laboratory.
• Left ventricular hypertrophy or left ventricular dilatation assessed by echocardiography at screening measured by central laboratory with any of the following:

• LVMi greater than (>)88 g/m\^2 for female participants and >102 g/m\^2 for male participants using the truncated ellipsoid method.
• LVMi >95 g/m\^2 for female participants and >115 g/m\^2 for male participants, using the linear method (cube formula).
• Left ventricular end-diastolic diameter indexed to body surface area (LVEDDi) >3.1 cm/m\^2 for female participants and >3.0 cm/m\^2 for male participants.
• Body mass index 18.5-40 kilogram per meter square (kg/m\^2) (both inclusive) and body weight less than or equal to (≤) 140 kilogram (kg). Body mass index is calculated in the electronic case report form based on height and body weight at the screening visit (visit 1).
• N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥ 300 picograms per milliliter (pg/mL); NT-proBNP ≥600 pg/mL if atrial fibrillation/flutter is present at time of screening, measured by central laboratory.

Критерии исключения

• Estimated Glomerular Filtration Rate (eGFR) less than (<) 30 milliliter/minute/ 1.73-meter square (mL/min/1.73 m\^2) at time of screening, measured by central laboratory.
• Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the investigator,within 90 days prior to randomisation.
• Myocardial infarction, unstable angina pectoris or HF hospitalization within 30 days prior to screening.
• Participants receiving intravenous HF medications within 45 days prior to randomisation.
• Planned coronary revascularization, pacemaker/cardioverter-defibrillator/cardiac resynchronization therapy (CRT) implantation, ablation of cardiac arrythmias or valve repair/replacement at the time of randomisation.
• Stroke or transient ischemic attack within 12 months prior to randomisation.
• Participants with potential disruption of the blood-brain barrier (e.g., multiple sclerosis), in the opinion of the investigator.
• Known history of severe liver disease and/or alanine aminotransferase or aspartate aminotransferase greater than (>) 2.5x upper limit of normal at screening, measured by central laboratory.
• Known genetic (or highly suspected due to family history) cause of increased cardiac mass (including dilated cardiomyopathy, Fabry disease and likely pathogenic or pathogenic variants within hypertrophic cardiomyopathy (HCM).
• Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Япония · 13 центров

• NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine — Bunkyo-ku, Tokyo
• JA Shizuoka Kohseiren Enshu Hospital_ Cardiology — Hamamatsu-shi, Shizuoka
• Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology — Himeji-shi, Hyogo
• National Hospital Organization Mito Medical Center_Cardiovascular medicine — Ibaraki
• Yokohama City University Medical Center_Cardiovascular Center — Kanagawa
• Yokohama City University Medical Center_Cardiovascular Center — Kanagawa
• Kagawa University Hospital_Cardiology — Kita-gun, Kagawa
• Kobe City Medical Center General Hospital_Cardiology — Kobe-shi, Hyogo
• … и ещё 5 центров

Испания · 13 центров

• Hospital Universitario San Cecilio — Granada
• Hospital Univ. de Gerona Doctor Josep Trueta — Girona
• Hospital Univ. Virgen de la Arrixaca — El Palmar
• Hospital del Mar — Barcelona
• Hospital de Dénia_Cardiología — Denia
• Hospital Virgen de la Arrixaca — El Palmar
• Hospital Univ. de Gran Canaria Doctor Negrín — Las Palmas de Gran Canaria
• Hospital Ramón y Cajal_Cardiología — Madrid
• … и ещё 5 центров

Индия · 11 центров

• Rhythm Heart Institute — Vadodara
• Lisie Hospital — Kochi
• Seth GS Medical College & KEM Hospital — Mumbai
• Arneja Heart & Multispeciality Hospital — Nagpur
• Arneja Heart & Multispeciality Hospital — Nagpur
• G B Pant Institute of Postgraduate Medical Education and Research — New Delhi
• VMMC & Safdarjung Hospital — New Dehli
• Dayanand Medical College & Hospital — Ludhiana
• … и ещё 3 центра

Польша · 11 центров

• 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej — Wroclaw
• 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ — Lublin
• Uniwersytecki Szpital Kliniczny w Bialymstoku — Bialystok
• Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej — Biała Podlaska
• American Heart of Poland S.A. — Bielsko-Biala
• Krakowski Szpital Specjalistyczny im. Jana Pawla II — Krakow
• Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. — Krakow
• Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie — Lublin
• … и ещё 3 центра

Германия · 10 центров

• Sana Kliniken Berlin-Brandenburg GmbH - Lichtenberg — Berlin
• Charité - Campus Benjamin Franklin - Klinik für Kardiologie — Berlin
• Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU) — Berlin
• Uniklinik TU Dresden - Herzzentrum Dresden GmbH — Dresden
• Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie — Essen
• Universitätsklinikum Frankfurt aM - Kardiologie — Frankfurt am Main
• Universitätsklinikum Halle - Innere Medizin III — Halle
• Medizinische Hochschule Hannover - Kardiologie und Angiologie — Hanover
• … и ещё 2 центра

South Korea · 8 центров

• Chungbuk National University Hospital — Cheongju-si
• Keimyung University Dongsan Hospital — Daegu
• Wonju Severance Christian Hospital — Gangwon-do
• Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do
• Korea University Anam Hospital — Seoul
• Severance Hospital, Yonsei University Health System — Seoul
• Korea University Guro Hospital — Seoul
• Korea University Guro Hospital — Seoul

Великобритания · 8 центров

Список центров уточняется — проверьте первичный протокол.

Австралия · 7 центров

• Concord Repatriation General Hospital - Cardiology Department — Concord
• The Prince Charles Hospital — Brisbane
• Royal Adelaide Hospital - Cardiology Department — Adelaide
• Flinders Medical Centre — Bedford Park
• Royal Hobart Hospital — Hobart
• Victorian Heart Hospital — Clayton
• Fiona Stanley Hospital - Cardiology — Murdoch

Чехия · 6 центров

• Fakultní nemocnice u sv. Anny v Brně — Brno
• Nemocnice České Budějovice a.s. — České Budějovice
• Fakultní Nemocnice Ostrava — Ostrava-Poruba
• Vseobecna fakultni nemocnice v Praze — Prague
• Pratia Prague, s.r.o — Prague
• IKEM — Prague

Нидерланды · 5 центров

• AmsterdamUMC AMC — Amsterdam
• Zuyderland ziekenhuis - Cardiologie — Heerlen
• Radboudumc — Nijmegen
• Erasmus MC — Rotterdam
• VieCuri - Cardiologie — Venlo

Идентификаторы

NCT: NCT06979375 · NN6706-8282 · U1111-1313-4591 · 2024-515797-27 · jRCT2031250305

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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