Clinical trial • Phase II • Cardiology

Nucleic Acid for Heart failure with preserved ejection fraction | Left ventricular hypertrophy

Phase II trial of Nucleic Acid for Heart failure with preserved ejection fraction | Left ventricular hypertrophy.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Heart failure with preserved ejection fraction | Left ventricular hypertrophy
Trial Stage
Phase II
Drug Modality
Other RNA

Key dates

Initial CTIS Submission Date
07-02-2025
First CTIS Authorization Date
28-05-2025

Trial design

Randomised, placebo arm: placebo q4w (placebo administered every 4 weeks). active comparator: cdr132l administered q4w at multiple dose levels (specific mg/kg dose values are redacted/unspecified in the record); both added to standard of care.-controlled Phase II trial across 25 sites in Poland, Germany, Spain.

Randomised
Yes
Comparator
Placebo arm: placebo Q4W (placebo administered every 4 weeks). Active comparator: CDR132L administered Q4W at multiple dose levels (specific mg/kg dose values are redacted/unspecified in the record); both added to standard of care.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
150
Trial Duration For Participant
420

Eligibility

Recruits 150 No vulnerable populations selected; participants are adults (age 40-84 years). Informed consent is required from each participant; no assent process for minors is described..

Vulnerable Population
No vulnerable populations selected; participants are adults (age 40-84 years). Informed consent is required from each participant; no assent process for minors is described.

Inclusion criteria

  • {"criterion_text":"-1. Age 40-84 years (both inclusive) at the time of signing the informed consent."}
  • {"criterion_text":"-2. Documented symptomatic HF diagnosed ≥90 days prior to screening with at least weekly need for oral diuretic treatment, and New York Heart Association class II−III at screening."}
  • {"criterion_text":"-3. Clinically stable and on optimised doses and unchanged drug classes of guideline-directed HF therapy ≥45 days prior to randomisation."}
  • {"criterion_text":"-4. Left ventricular ejection fraction ≥50% as assessed by echocardiography at screening, measured by central laboratory."}
  • {"criterion_text":"-5. Left ventricular hypertrophy assessed by echocardiography at screening measured by central laboratory with any of the following: a. LVMi >88 g/m2 for female participants and >102 g/m2 for male participants, using the truncated ellipsoid method. b. LVMi >95 g/m2 for female participants and >115 g/m2 for male participants using the linear method (cube formula). c. Interventricular septum diameter measured in diastole (IVSd) in the parasternal long axis view ≥1.1 cm for female participants and ≥1.2 cm for male participants."}
  • {"criterion_text":"-7. Body mass index 18.5-40 kg/m2 (both inclusive) and body weight ≤140 kg. Body mass index is calculated in the electronic case report form based on height and body weight at the screening visit (visit 1)."}
  • {"criterion_text":"-8. NT-proBNP ≥300 pg/mL; NT-proBNP ≥600 pg/mL if atrial fibrillation/flutter is present at time of screening, measured by central laboratory."}

Exclusion criteria

  • {"criterion_text":"-1. Estimated glomerular filtration rate <30 mL/min/1.73 m2 at time of screening, measured by central laboratory."}
  • {"criterion_text":"-9. Known history of severe liver disease and/or alanine aminotransferase or aspartate aminotransferase >2.5× upper limit of normal at screening, measured by central laboratory."}
  • {"criterion_text":"-11. Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis"}
  • {"criterion_text":"-10. 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])."}
  • {"criterion_text":"-2. Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the investigator, within 90 days prior to randomisation."}
  • {"criterion_text":"-3. Myocardial infarction, unstable angina pectoris or HF hospitalisation within 30 days prior to screening."}
  • {"criterion_text":"-4. Participants receiving intravenous HF medications within 45 days prior to randomisation."}
  • {"criterion_text":"-5. Participants with CRT, pacemaker or implantable cardioverter-defibrillator."}
  • {"criterion_text":"-6. Planned coronary revascularisation, pacemaker/cardioverter-defibrillator/CRT implantation, ablation of cardiac arrythmias and valve repair/replacement at the time of randomisation."}
  • {"criterion_text":"-7. Stroke or transient ischemic attack within 12 months prior to randomisation."}
  • {"criterion_text":"-8. Participants with potential disruption of the blood-brain barrier (e.g., multiple sclerosis), in the opinion of the investigator."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Change in normalised miR-132 from baseline (V2) to week 24 (V14). Unit:  Ratio to baseline","definition_or_measurement_approach":"Measured from baseline (V2) to week 24 (V14); unit: Ratio to baseline. miR-132 measured using the miR-132 assay (BioAgilytix Europe GmbH is listed as supplier for the miR-132 assay)."}

Secondary endpoints

  • {"endpoint_text":"-Change in composite Z-score based on the 3 outcome measures LVMi (CMR), LAVi (CMR) and NT-proBNP from baseline (V2) to week 24 (V14). Unit: Score","definition_or_measurement_approach":"Composite Z-score derived from LVMi (measured by CMR), LAVi (measured by CMR) and NT-proBNP (measured by central laboratory) from baseline (V2) to week 24 (V14). Unit: score."}
  • {"endpoint_text":"-Change in normalised miR-132 from baseline (V2) to week 24 (V14). Unit: Ratio to baseline","definition_or_measurement_approach":"Measured from baseline (V2) to week 24 (V14); unit: Ratio to baseline. miR-132 measured using the miR-132 assay."}
  • {"endpoint_text":"-Number of adverse events from baseline (V2) to week 24 (V14). Unit: Count","definition_or_measurement_approach":"Count of adverse events recorded from baseline (V2) through week 24 (V14)."}
  • {"endpoint_text":"-Number of adverse events From baseline (V2) to week 60 (V27). Unit: Count","definition_or_measurement_approach":"Count of adverse events recorded from baseline (V2) through week 60 (V27)."}

Recruitment

Planned Sample Size
150
Recruitment Window Months
16
Consent Approach
Informed consent is obtained from each adult participant prior to study procedures. Subject information and informed consent forms are provided (documents available in multiple languages including English, German, Spanish and Polish as per published documents). Specific age-based assent is not described.

Methods

  • HCP referral (referral information sheets and referral forms referenced in recruitment documents)
  • Patient-facing advertisements and trial recruitment adverts (country-specific patient-facing adverts documented for Germany and Spain and English materials available)
  • HCP-targeted advertisements and recruitment materials (documents reference HCP trial recruitment adverts)
  • Printed flyers and participant support/network booklets (patient-facing study booklets and support materials listed)
  • Clinic-based recruitment and echo/MRI volunteer recruitment (clinic visit overviews and imaging volunteer materials listed)

Geography

Total Number Of Sites
25
Total Number Of Participants
50

Poland

Earliest CTIS Part Ii Submission Date
25-02-2025
Latest Decision Or Authorization Date
30-11-2025
Processing Time Days
278
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Department Name
Narodowy Instytut Kardiologii, Centrum Wsparcia Badań Klinicznych
Contact Person Name
Mariusz Kruk
Contact Person Email
mkruk@ikard.pl
Site Name
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Department Name
Oddział Kardiologii i Chorób Wewnętrznych
Contact Person Name
Piotr Rychlak
Contact Person Email
petrus_r@o2.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Zakład Badań Klinicznych Chorób Układu Krążenia
Contact Person Name
Joanna Szachniewicz
Contact Person Email
jszachniewicz@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Klinika Kardiologii i Chorób Wewnętrznych z OINK
Contact Person Name
Anna Lisowska
Contact Person Email
anlila@poczta.onet.pl
Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Contact Person Name
Lukasz Wisniowski
Contact Person Email
drlukaszwisniowski@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Centrum Innowacyjnych Terapii
Contact Person Name
Lukasz Wisniowski
Contact Person Email
drlukaszwisniowski@gmail.com
Site Name
American Heart Of Poland S.A.
Department Name
Centrum Kardiologii i Kardiochirurgii
Contact Person Name
Krzysztof Milewski
Contact Person Email
krzysztof.milewski@ahop.pl
Site Name
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclaw
Department Name
Osrodek Chorob Serca
Contact Person Name
Bartosz Krakowiak
Contact Person Email
bartek.krakowiak@gmail.com
Site Name
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Department Name
Klinika Kardiologii Interwencyjnej
Contact Person Name
Jakub Podolec
Contact Person Email
jakub.podolec@uj.edu.pl

Germany

Earliest CTIS Part Ii Submission Date
04-04-2025
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
354
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Universitätsklinikum Schleswig-Holstein - Medizinischen Klinik III Kardiologie und Internistische In
Contact Person Name
Derk Frank
Contact Person Email
derk.frank@uksh.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU)
Contact Person Name
Frank Edelmann
Contact Person Email
frank.edelmann@dhzc-charite.de
Site Name
Charite Universitaetsmedizin Berlin KöR (Lichterfelde)
Department Name
Charité B.Franklin Kardio + Hämatologie
Contact Person Name
Ursula Rauch-Kröhnert
Contact Person Email
ursula.rauch@dhzc-charite.de
Site Name
Medizinische Hochschule Hannover
Department Name
Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie
Contact Person Name
Johann Bauersachs
Site Name
Universitaetsklinikum Essen AöR
Department Name
Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie
Contact Person Name
Tienush Rassaf
Contact Person Email
tienush.rassaf@uk-essen.de
Site Name
Herzzentrum Dresden GmbH Universitaetsklinik
Department Name
Herzzentrum Dresden GmbH Universitätsklinik
Contact Person Name
Ephraim Winzer
Contact Person Email
ephraim.winzer@tu-dresden.de
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Universitätsklinikum Halle - Innere Medizin III
Contact Person Name
Daniel Sedding
Contact Person Email
Daniel.Sedding@uk-halle.de
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Universitätsklinikum Frankfurt aM - Kardiologie
Contact Person Name
Sebastian Cremer
Contact Person Email
cremer@med.uni-frankfurt.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie
Contact Person Name
Norbert Frey

Spain

Earliest CTIS Part Ii Submission Date
25-02-2025
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
426
Number Of Sites
7
Number Of Participants
10

Sites

Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Hospital Virgen de la Arrixaca
Contact Person Name
Domingo Pascual Figal
Contact Person Email
dpascual@um.es
Site Name
Hospital Universitario La Paz
Department Name
Hospital Universitario La Paz
Contact Person Name
María Isabel Antorrena Miranda
Contact Person Email
iantorrena@hotmail.com
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Hospital Universitario San Cecilio
Contact Person Name
Jesús Gabriel Sánchez Ramos
Site Name
Hospital Del Mar
Department Name
Hospital del Mar_Cardiología - Ensayos Clínicos
Contact Person Name
Sonia Ruiz Bustillo
Contact Person Email
sruiz@psmar.cat
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Hospital Clínico Universitario de Valencia
Contact Person Name
Julio Núñez Villota
Contact Person Email
juenuvi@uv.es
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
Hosp. U Gran Canaria Dr. Negrín_Cardiologia
Contact Person Name
Antonio García Quintana
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hospital Ramón y Cajal_Cardiología
Contact Person Name
Marta Jiménez Blanco Bravo

Sponsor

Primary sponsor

Full Name
Novo Nordisk A/S
Organisation Type
Pharmaceutical company
Country Of Registered Address
Denmark

Contract research organisations

Name
Fortrea Inc.
Responsibilities
Data Management and Biostatistics – CRO

Third parties

  • {"country":"Denmark","full_name":"Oracle Danmark ApS","duties_or_roles":"Global Safety Database supplier","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Iqvia Rds Ireland Limited","duties_or_roles":"ECG","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"Imaging service","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Vivos Technology Limited","duties_or_roles":"DMC","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM/IWRS supplier","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Packaging and labelling","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"miR-132 assay","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"FyoniBio GmbH","duties_or_roles":"immunogenicity","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Data Management and Biostatistics – CRO","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"Exploratory biomarkers","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"Olink Proteomics AB","duties_or_roles":"Proteomics","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"KLIFO A/S","duties_or_roles":"Equipment, Pump, Syringe and Tube","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Axolabs GmbH","duties_or_roles":"Pharmacokinetics","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
CDR132L (sponsor product code CDR132L A 10043)
Active Substance
Nucleic Acid
Modality
Other RNA
Frequency
Every 4 weeks (Q4W)
Investigational Product Name
Placebo
Modality
Other
Frequency
Every 4 weeks (Q4W)
Combination Treatment
Yes

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