Myocardial Infarction, AcutePhase 2HF-REVERTNCT05350969
Study to Assess Efficacy and Safety of CDR132L in Patients With Reduced Left Ventricular Ejection Fraction After Myocardial Infarction
A Phase 2 study testing CDR132L in people with Myocardial Infarction, Acute and Heart Failure, Left Sided, run by Cardior Pharmaceuticals GmbH at 49 sites in 8 countries.
Trial summary
This is a Phase 2, multicenter, randomized, parallel, 3-arm, placebo-controlled study to assess efficacy and safety of CDR132L in patients with reduced Left Ventricular Ejection Fraction (LVEF) (≤ 45%) after myocardial infarction (MI). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Myocardial Infarction, Acute, Heart Failure, Left Sided
- What is being tested?
- CDR132L
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 49 sitesin 8 countries
- Study dates
- 11 Jul 2022to 17 Mar 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- A woman of childbearing potential (WOCBP).
- Patient with HF of non-ischemic origin; e.g., myocarditis, alcoholic cardiomyopathy.
- Patient with New York Heart Association (NYHA) class IV at screening or randomization.
- Patient has any planned cardiac intervention (angiogram without angioplasty is acceptable) or any other planned surgery after the Screening Period.
- Patient has severe valvular heart disease.
- Patient has systolic BP < 90 mmHg or > 180 mmHg, diastolic BP < 50 mmHg or > 110 mmHg, and/or heart rate < 50 or > 100 beats/minute at screening or randomization.
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- Patient with an estimated glomerular filtration rate < 30 mL/min/1.73 m2 or on dialysis.
- Patient with hepatic insufficiency classified as Child-Pugh B or C.
- Patient has medical history of disease(s) affecting the blood-brain-barrier, e.g., stroke within 6 months or multiple sclerosis.
- Patient has medical history of bleeding disorders or has thrombocytopenia (platelets < 100,000/μL).
- Patient has poorly controlled diabetes as determined by the Investigator.
- Patient has a history or presence of any of the following cardiac conditions: known structural cardiac abnormalities beyond HF, family history of long QT syndrome, cardiac syncope, or recurrent, idiopathic syncope.
- Any clinically significant abnormalities, at the discretion of the Investigator, in rhythm, conduction, or morphology of resting ECG that pose an additional safety risk to patients.
- Patient with active "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)" infection confirmed as per the local testing guidelines at screening.
- Patient is not to be enrolled into the study if they received any prohibited therapy within 3 months of screening.
Trial locations and contacts
49 sites in 8 countries.
49 sites in 8 countries
Poland12 sites
Polsko Amerykanskie Kliniki Serca
Kędzierzyn-Koźle
Specjalistyczna Poradnia Kardiologiczna i Nadcisnienia Tetniczego
Kielce
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow
Gabinet Internistyczno-Kardiologiczny Jacek Nowak
Libiąż
NZOZ SALUS JZ Peruga
Lodz
One wojskowy Szpital Kliniczny w Lublinie
Lublin
Medicome Sp. z o.o.
Oświęcim
Wojewódzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl
NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog
Sopot
Wojewodzki Szpital Zespolony
Torun
Spec.Szpital im.dr Sokolowskiego
Wałbrzych
Investigational Site
Wroclaw
Netherlands10 sites
Jeroen Bosch Ziekenhuis (JBZ) (Hieronymus Bosch Hospital) - locatie Den Bosch
's-Hertogenbosch
Deventer Ziekenhuis
Deventer
Slingeland Ziekenhuis
Doetinchem
Gelderse Vallei Ziekenhuis
Ede
Medisch Centrum Leeuwarden
Leeuwarden
St. Jansdal Ziekenhuis
Lelystad
Erasmus University Medical Center
Rotterdam
Ikazia Ziekenhuis
Rotterdam
D & A Research B.V.
Sneek
Gelre Ziekenhuizen
Zutphen
Spain9 sites
Hospital Universitari Germans Trias i Pujol
Badalona
Hospital de la Santa Creu I Sant Pau
Barcelona
Hospital Universitario San Cecilio
Granada
Hospital Universitario La Paz
Madrid
Hospital Universitario Virgen de la Arrixaca
Murcia
Hospital Universitario de Sabadell
Sabadell
Hospital Universitario Virgen Macarena
Seville
Hospital Clinico Universitario de Valencia
Valencia
Complejo Hospitalario Universitario de Vigo
Vigo
Germany8 sites
St. Marien-Krankenhaus Ahaus
Ahaus
Herzzentrum Dresden Universitätsklinik
Dresden
Helios Klinikum Erfurt
Erfurt
Universitätsmedizin Göttingen
Göttingen
Medizinische Hochschule Hannover
Hanover
Universitätsklinikum Schleswig-Holstein
Kiel
Klinikum Ludwigshafen
Ludwigshafen
Universitätsklinikum Würzburg
Würzburg
United Kingdom4 sites
Queen Elizabeth University Hospital
Glasgow
Wycombe Hospital
High Wycombe
Richmond Pharmacology Limited
London
South Tees Hospital NHS Foundation Trust
Middlesbrough
Greece3 sites
"Alexandra" General Hospital of Athens
Athens
"Attikon" General University Hospital
Athens
General University Hospital of Patras "Panagia i Voitheia"
Pátrai
Czechia2 sites
Institut klinicke a experimentalni mediciny
Prague
Všeobecná fakultní nemocnice v Praze
Prague
About this study
Official title: Phase 2, Multicenter, Randomized, Parallel, 3-arm, Placebo-controlled Study to Assess Efficacy and Safety of CDR132L in Patients With Reduced Left Ventricular Ejection Fraction (≤ 45%) After Myocardial Infarction
This is a Phase 2, multicenter, randomized, parallel, 3-arm, placebo-controlled study to assess efficacy and safety of CDR132L in patients with reduced Left Ventricular Ejection Fraction (LVEF) (≤ 45%) after myocardial infarction (MI). This study consists of a screening period (to occur at least 3 days after MI diagnosis), a 6-month double-blind period, and a 6-month extension period with the End of Study (EOS) Visit at Day 360/Month 12.
Two dosages of CDR132L will be tested against placebo on their effects on patients, who just had a heart attack in addition to standard care. The aim of the study is to show that CDR132L is safe and effective to improve heart failure in such patients.
- Being tested
- CDR132L, Placebo to CDR132L
- Medical subject headings
- Myocardial Infarction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDR132LDrug
CDR132L is a synthetic antisense oligonucleotide (ASO) and a selective inhibitor of microRNA-132-3p (miR-132). miR-132 in cardiomyocytes is a central switch affecting the expression of genes that are crucially involved in maladaptive cardiac remodeling, transformation, and pathological cardiac growth (hypertrophy), contributing to adverse cardiac remodeling and heart failure (HF).1-5 Aberrant expression of miR-132 in cardiac cells is causally associated with cardiac remodeling and HF progression.
Placebo to CDR132LDrug
Placebo to CDR132L
| Study group | Role | What they receive |
|---|---|---|
| CDR132L 5 mg | Experimental | CDR132L 5 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57 Receives: Drug: CDR132L |
| CDR132L 10 mg | Experimental | CDR132L 10 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57 Receives: Drug: CDR132L |
| Placebo | Placebo comparator | Placebo intravenous in single dose on Day 1, Day 29 and Day 57 Receives: Drug: Placebo to CDR132L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in LVESVI (Left Ventricular End-systolic Volume Index) at Month 6
Percent change from baseline in LVESVI at Month 6 is presented. LVESVI is considered one of the standard echocardiography (ECHO) markers for assessing risks in ischemic heart failure (HF). The ECHO was performed to assess LVESVI.
Measured: Baseline (Day 1), Month 6
Secondary outcomes (40)
Number of Treatment Emergent Adverse Events (TEAEs)
Number of TEAEs were presented. TEAEs were defined as AEs that first occurred or worsened in severity after the first administration of study treatment and prior to 30 days after the last administration of study treatment.
Measured: Up to 12 months
Number of Treatment Emergent Serious Adverse Events (TESAEs)
Number of TESAEs are presented. TEAEs were defined as AEs that first occurred or worsened in severity after the first administration of study treatment and prior to 30 days after the last administration of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: a) results in death, b) is life-threatening, c) requires inpatient hospitalization or prolongation of existing hospitalization, d) results in persistent disability/incapacity, e) is a congenital anomaly/birth defect, f) other situations where medical or scientific judgement should be excercised.
Measured: Up to 12 months
Number of Participants With Abnormalities in Clinically Relevant Laboratory Assessments
Number of participants with abnormalities in clinically relevant laboratory assessments up to month 6 is presented. Laboratory investigation included hematology, chemistry, coagulation and urinalysis parameters. Clinical relevance was decided by the investigator.
Measured: At month 6
Number of Participants With Clinically Relevant Laboratory Abnormalities in Vital Signs Parameters
Number of participants with clinically relevant laboratory abnormalities in vital signs parameters on month 12 is presented. Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate. Clinical relevance was decided by the investigator.
Measured: At month 12
Number of Participants With Clinically Relevant Laboratory Abnormalities in ECG Parameters
Number of participants with clinically relevant laboratory abnormalities in ECG parameters at month 12 is presented. The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. The parameters included heart rate (HR), Pulse Rate, QRS, QT interval. Clinical relevance was decided by the investigator.
Measured: At month 12
Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 3
Absolute change from baseline in LVEF at month 3 is presented. LVEF is an established method for evaluation of left ventricular systolic function. A 2D echocardiography (ECHO) was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Measured: Baseline (Day 1), Month 3
Absolute Change From Baseline in LVEF at Month 6
Absolute change from baseline in LVEF at month 6 is reported. LVEF is an established method for evaluation of left ventricular systolic function. A 2D ECHO was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Measured: Baseline (Day 1), Month 6
Absolute Change From Baseline in LVEF at Month 12
Absolute change from baseline in LVEF at month 12 is reported. LVEF is an established method for evaluation of left ventricular systolic function. A 2D ECHO was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Measured: Baseline (Day 1), Month 12
Relative Change From Baseline in LVEF at Month 3
Relative change from baseline in LVEF at month 3 is presented. LVEF is an established method for evaluation of left ventricular systolic function. A 2D ECHO was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Measured: Baseline (Day 1), Month 3
Relative Change From Baseline in LVEF at Month 6
Relative change from baseline in LVEF at month 6 is presented. LVEF is an established method for evaluation of left ventricular systolic function. A 2D ECHO was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Measured: Baseline (Day 1), Month 6
Relative Change From Baseline in LVEF at Month 12
Relative change from baseline in LVEF at month 12 is presented. LVEF is an established method for evaluation of left ventricular systolic function. A 2D ECHO was performed in the ECHO central laboratory by trained personnel to assess LVEF. Contrast ECHO was available as an option to enhance image quality.
Measured: Baseline (Day 1), Month 12
Absolute Change From Baseline in LVESVI at Month 3
Absolute change from baseline in LVESVI at month 3 is presented. LVESVI is considered one of the standard ECHO markers for assessing risks in ischemic HF. The ECHO was performed to assess LVESVI.
Measured: Baseline (Day 1), Month 3
Absolute Change From Baseline in LVESVI at Month 6
Absolute change from baseline in LVESVI at month 6 is presented. LVESVI is considered one of the standard ECHO markers for assessing risks in ischemic HF. The ECHO was performed to assess LVESVI.
Measured: Baseline (Day 1), Month 6
Absolute Change From Baseline in LVESVI at Month 12
Absolute change from baseline in LVESVI at month 12 is presented. LVESVI is considered one of the standard ECHO markers for assessing risks in ischemic HF. The ECHO was performed to assess LVESVI.
Measured: Baseline (Day 1), Month 12
Relative Change From Baseline in LVESVI at Month 3
Relative change from baseline in LVESVI at month 3 is presented. LVESVI is considered one of the standard ECHO markers for assessing risks in ischemic HF. The ECHO was performed to assess LVESVI.
Measured: Baseline (Day 1), Month 3
Relative Change From Baseline in LVESVI at Month 12
Relative change from baseline in LVESVI at month 12 is presented. LVESVI is considered one of the standard ECHO markers for assessing risks in ischemic HF. The ECHO was performed to assess LVESVI.
Measured: Baseline (Day 1), Month 12
Absolute Change From Baseline in Troponin T at Month 3
Absolute change from baseline in troponin T at month 3 is presented. Troponin T levels were measured by high-sensitivity cardiac troponin (hs-cTn) assays.
Measured: Baseline (Day 1), Month 3
Absolute Change From Baseline in Troponin T at Month 6
Absolute change from baseline in troponin T at month 6 is presented. Troponin T levels were measured by hs-cTn assays.
Measured: Baseline (Day 1), Month 6
Absolute Change From Baseline in Troponin T at Month 12
Absolute change from baseline in troponin T at month 12 is presented. Troponin T levels were measured by hs-cTn assays.
Measured: Baseline (Day 1), Month 12
Relative Change From Baseline in Troponin T at Month 3
Relative change from baseline in troponin T at month 3 is presented. Troponin T levels were measured by hs-cTn assays.
Measured: Baseline (Day 1), Month 3
Relative Change From Baseline in Troponin T at Month 6
Relative change from baseline in troponin T at month 6 is presented. Troponin T levels were measured by hs-cTn assays.
Measured: Baseline (Day 1), Month 6
Relative Change From Baseline in Troponin T at Month 12
Relative change from baseline in troponin T at month 12 is presented. Troponin T levels were measured by hs-cTn assays.
Measured: Baseline (Day 1), Month 12
Absolute Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Month 1
Absolute change from baseline in NT-proBNP at month 1 is presented.
Measured: Baseline (Day 1), Month 1
Absolute Change From Baseline in NT-proBNP at Month 2
Absolute change from baseline in NT-proBNP at month 2 is presented.
Measured: Baseline (Day 1), Month 2
Absolute Change From Baseline in NT-proBNP at Month 3
Absolute change from baseline in NT-proBNP at month 3 is presented.
Measured: Baseline (Day 1), Month 3
Absolute Change From Baseline in NT-proBNP at Month 6
Absolute change from baseline in NT-proBNP at month 6 is presented.
Measured: Baseline (Day 1), Month 6
Absolute Change From Baseline in NT-proBNP at Month 12
Absolute change from baseline in NT-proBNP at month 12 is presented.
Measured: Baseline (Day 1), Month 12
Relative Change From Baseline in NT-proBNP at Month 1
Relative change from baseline in NT-proBNP at month 1 is presented.
Measured: Baseline (Day 1), Month 1
Relative Change From Baseline in NT-proBNP at Month 2
Relative change from baseline in NT-proBNP at month 2 is presented.
Measured: Baseline (Day 1), Month 2
Relative Change From Baseline in NT-proBNP at Month 3
Relative change from baseline in NT-proBNP at month 3 is presented.
Measured: Baseline (Day 1), Month 3
Relative Change From Baseline in NT-proBNP at Month 6
Relative change from baseline in NT-proBNP at month 6 is presented.
Measured: Baseline (Day 1), Month 6
Relative Change From Baseline in NT-proBNP at Month 12
Relative change from baseline in NT-proBNP at month 12 is presented.
Measured: Baseline (Day 1), Month 12
Absolute Change From Baseline in Mean KCCQ Score (Overall Summary Score) at Month 6
Absolute change from baseline in mean Kansas City Cardiomyopathy Questionnaire (KCCQ) score (overall summary score) at month 6 is presented. The KCCQ is a 23-item, self-administered ques-tionnaire developed to independently measure the participant's perception of their health status. Scores range from 0 to 100, with 0 as lowest score and 100 as the highest score. Higher scores indi-cate better health status, fewer symptoms, and greater disease-specific health-related quality of life. The calculation is following the KCCQ scoring manual that states: "Overall Summary Score is defined as mean of the following available summary scores: Physical Limitation Score, Total Symptom Score, Quality of Life Score and Social Limitation Score". Because the manual states that the Overall Sum-mary Score should be calculated on available scores, then if physical limitation score is missing, but other sub scores are available the Overall Summary Score will be calculated anyhow based on other sub scores.
Measured: Baseline (Day 1), Month 6
Absolute Change From Baseline in Mean KCCQ Score (Overall Summary Score) at Month 12
Absolute change from baseline in mean KCCQ score (overall summary score) at month 12 is presented. The KCCQ is a 23-item, self-administered ques-tionnaire developed to independently measure the participant's perception of their health status. Scores range from 0 to 100, with 0 as lowest score and 100 as the highest score. Higher scores indi-cate better health status, fewer symptoms, and greater disease-specific health-related quality of life. The calculation is following the KCCQ scoring manual that states: "Overall Summary Score is defined as mean of the following available summary scores: Physical Limitation Score, Total Symptom Score, Quality of Life Score and Social Limitation Score". Because the manual states that the Overall Summary Score should be calculated on available scores, then if physical limitation score is missing, but other sub scores are available the Overall Summary Score will be calculated anyhow based on other sub scores.
Measured: Baseline (Day 1), Month 12
Absolute Change From Baseline in KCCQ Subdomain Score (Symptom Burden) at Month 6
Absolute change from baseline in KCCQ subdomain score (symptom burden) at month 6 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Symptom burden: scores on a scale of 0 to 100, higher scores means better outcome.
Measured: Baseline (Day 1), Month 6
Absolute Change From Baseline in KCCQ Subdomain Score (Symptom Burden) at Month 12
Absolute change from baseline in KCCQ subdomain score (symptom burden) at month 12 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Symptom burden: scores on a scale of 0 to 100, higher scores means better outcome.
Measured: Baseline (Day 1), Month 12
Absolute Change From Baseline in KCCQ Subdomain Score (Physical Limitation) at Month 6
Absolute change from baseline in KCCQ subdomain score (physical limitation) at month 6 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Physical limitation: scores on a scale of 0 to 100, higher scores means better outcome.
Measured: Baseline (Day 1), Month 6
Absolute Change From Baseline in KCCQ Subdomain Score (Physical Limitation) at Month 12
Absolute change from baseline in KCCQ subdomain score (physical limitation) at month 12 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Physical limitation: scores on a scale of 0 to 100, higher scores means better outcome.
Measured: Baseline (Day 1), Month 12
Absolute Change From Baseline in KCCQ Subdomain Score (Quality of Life) at Month 6
Absolute change from baseline in KCCQ subdomain score (quality of life) at month 6 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Quality of life: scores on a scale of 0 to 100, higher scores means better outcome.
Measured: Baseline (Day 1), Month 6
Absolute Change From Baseline in KCCQ Subdomain Score (Quality of Life) at Month 12
Absolute change from baseline in KCCQ subdomain score (quality of life) at month 12 is presented. The KCCQ is a 23-item, self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes HF symptoms, impact on physical and social function, and how their HF impacts their quality of life within a 2-week recall period. The 7 domains under KCCQ include: Physical Limitation (6 items), Symptom Stability (1 item), Symptom Frequency (4 items), Symptom Burden (3 items), Self-Efficacy (2 items), Quality of Life (3 items), Social Limitations (4 items). Quality of life: scores on a scale of 0 to 100, higher scores means better outcome.
Measured: Baseline (Day 1), Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start11 Jul 2022
- Primary completion26 Sep 2024
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardior Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johann Bauersachs, Prof. Dr., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350969
- Sponsor's protocol ID
- CDR132L-P2-01
- Other IDs
- 2023-507569-24-00, 2021-006040-27, 2023
- Acronym
- HF-REVERT
- Status last verified
- Jul 2026
- First submitted
- 20 Apr 2022
- Last updated
- 26 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bauersachs J, Solomon SD, Anker SD, Antorrena-Miranda I, de Boer RA, Filippatos G, Friede T, Hauke W, Ponikowski P, Vardeny O, Altschul R, Gamborg M, Vinther K, Thum T. The microRNA inhibitor CDR132L in patients with reduced left ventricular ejection fraction after myocardial infarction: a randomized phase 2 trial. Nat Med. 2026 Jul;32(7):2654-2661. doi: 10.1038/s41591-026-04408-4. Epub 2026 May 10.
PubMed 42108271
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multicenter, Randomized, Parallel, 3-arm, Placebo-controlled Study to Assess Efficacy and Safety of CDR132L in Patients With Reduced Left Ventricular Ejection Fraction (≤ 45%) After Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05350969
- Acronym / sponsor ID
- HF-REVERT / CDR132L-P2-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Cardior Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Posted 26 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, multicenter, randomized, parallel, 3-arm, placebo-controlled study to assess efficacy and safety of CDR132L in patients with reduced Left Ventricular Ejection Fraction (LVEF) (≤ 45%) after myocardial infarction (MI). This study consists of a screening period (to occur at least 3 days after MI diagnosis), a 6-month double-blind period, and a 6-month extension period with the End of Study (EOS) Visit at Day 360/Month 12.
Two dosages of CDR132L will be tested against placebo on their effects on patients, who just had a heart attack in addition to standard care. The aim of the study is to show that CDR132L is safe and effective to improve heart failure in such patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CDR132L 5 mg | Experimental | Drug: CDR132LCDR132L 5 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57 |
| CDR132L 10 mg | Experimental | Drug: CDR132LCDR132L 10 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57 |
| Placebo | Placebo comparator | Drug: Placebo to CDR132LPlacebo intravenous in single dose on Day 1, Day 29 and Day 57 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- A woman of childbearing potential (WOCBP).
- Patient with HF of non-ischemic origin; e.g., myocarditis, alcoholic cardiomyopathy.
- Patient with New York Heart Association (NYHA) class IV at screening or randomization.
- Patient has any planned cardiac intervention (angiogram without angioplasty is acceptable) or any other planned surgery after the Screening Period.
- Patient has severe valvular heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDR132LCDR132L is a synthetic antisense oligonucleotide (ASO) and a selective inhibitor of microRNA-132-3p (miR-132). miR-132 in cardiomyocytes is a central switch affecting the expression of genes that are crucially involved in maladaptive cardiac remodeling, transformation, and pathological cardiac growth (hypertrophy), contributing to adverse cardiac remodeling and heart failure (HF).1-5 Aberrant expression of miR-132 in cardiac cells is causally associated with cardiac remodeling and HF progression. | Drug | CDR132L 10 mg, CDR132L 5 mg |
| Placebo to CDR132LPlacebo to CDR132L | Drug | Placebo |
Primary outcome
Percent Change From Baseline in LVESVI (Left Ventricular End-systolic Volume Index) at Month 6
Time frame: Baseline (Day 1), Month 6
Percent change from baseline in LVESVI at Month 6 is presented. LVESVI is considered one of the standard echocardiography (ECHO) markers for assessing risks in ischemic heart failure (HF). The ECHO was performed to assess LVESVI.
40 secondary outcomes
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 12 months
Number of Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: Up to 12 months
Number of Participants With Abnormalities in Clinically Relevant Laboratory Assessments
Time frame: At month 6
Number of Participants With Clinically Relevant Laboratory Abnormalities in Vital Signs Parameters
Time frame: At month 12
Number of Participants With Clinically Relevant Laboratory Abnormalities in ECG Parameters
Time frame: At month 12
Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 3
Time frame: Baseline (Day 1), Month 3
Absolute Change From Baseline in LVEF at Month 6
Time frame: Baseline (Day 1), Month 6
Absolute Change From Baseline in LVEF at Month 12
Time frame: Baseline (Day 1), Month 12
Relative Change From Baseline in LVEF at Month 3
Time frame: Baseline (Day 1), Month 3
Relative Change From Baseline in LVEF at Month 6
Time frame: Baseline (Day 1), Month 6
Relative Change From Baseline in LVEF at Month 12
Time frame: Baseline (Day 1), Month 12
Absolute Change From Baseline in LVESVI at Month 3
Time frame: Baseline (Day 1), Month 3
Absolute Change From Baseline in LVESVI at Month 6
Time frame: Baseline (Day 1), Month 6
Absolute Change From Baseline in LVESVI at Month 12
Time frame: Baseline (Day 1), Month 12
Relative Change From Baseline in LVESVI at Month 3
Time frame: Baseline (Day 1), Month 3
Relative Change From Baseline in LVESVI at Month 12
Time frame: Baseline (Day 1), Month 12
Absolute Change From Baseline in Troponin T at Month 3
Time frame: Baseline (Day 1), Month 3
Absolute Change From Baseline in Troponin T at Month 6
Time frame: Baseline (Day 1), Month 6
Absolute Change From Baseline in Troponin T at Month 12
Time frame: Baseline (Day 1), Month 12
Relative Change From Baseline in Troponin T at Month 3
Time frame: Baseline (Day 1), Month 3
Relative Change From Baseline in Troponin T at Month 6
Time frame: Baseline (Day 1), Month 6
Relative Change From Baseline in Troponin T at Month 12
Time frame: Baseline (Day 1), Month 12
Absolute Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Month 1
Time frame: Baseline (Day 1), Month 1
Absolute Change From Baseline in NT-proBNP at Month 2
Time frame: Baseline (Day 1), Month 2
Absolute Change From Baseline in NT-proBNP at Month 3
Time frame: Baseline (Day 1), Month 3
Absolute Change From Baseline in NT-proBNP at Month 6
Time frame: Baseline (Day 1), Month 6
Absolute Change From Baseline in NT-proBNP at Month 12
Time frame: Baseline (Day 1), Month 12
Relative Change From Baseline in NT-proBNP at Month 1
Time frame: Baseline (Day 1), Month 1
Relative Change From Baseline in NT-proBNP at Month 2
Time frame: Baseline (Day 1), Month 2
Relative Change From Baseline in NT-proBNP at Month 3
Time frame: Baseline (Day 1), Month 3
Relative Change From Baseline in NT-proBNP at Month 6
Time frame: Baseline (Day 1), Month 6
Relative Change From Baseline in NT-proBNP at Month 12
Time frame: Baseline (Day 1), Month 12
Absolute Change From Baseline in Mean KCCQ Score (Overall Summary Score) at Month 6
Time frame: Baseline (Day 1), Month 6
Absolute Change From Baseline in Mean KCCQ Score (Overall Summary Score) at Month 12
Time frame: Baseline (Day 1), Month 12
Absolute Change From Baseline in KCCQ Subdomain Score (Symptom Burden) at Month 6
Time frame: Baseline (Day 1), Month 6
Absolute Change From Baseline in KCCQ Subdomain Score (Symptom Burden) at Month 12
Time frame: Baseline (Day 1), Month 12
Absolute Change From Baseline in KCCQ Subdomain Score (Physical Limitation) at Month 6
Time frame: Baseline (Day 1), Month 6
Absolute Change From Baseline in KCCQ Subdomain Score (Physical Limitation) at Month 12
Time frame: Baseline (Day 1), Month 12
Absolute Change From Baseline in KCCQ Subdomain Score (Quality of Life) at Month 6
Time frame: Baseline (Day 1), Month 6
Absolute Change From Baseline in KCCQ Subdomain Score (Quality of Life) at Month 12
Time frame: Baseline (Day 1), Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42108271Bauersachs J, Solomon SD, Anker SD, Antorrena-Miranda I, de Boer RA, Filippatos G, Friede T, Hauke W, Ponikowski P, Vardeny O, Altschul R, Gamborg M, Vinther K, Thum T. The microRNA inhibitor CDR132L in patients with reduced left ventricular ejection fraction after myocardial infarction: a randomized phase 2 trial. Nat Med. 2026 Jul;32(7):2654-2661. doi: 10.1038/s41591-026-04408-4. Epub 2026 May 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johann Bauersachs, Prof. Dr. principal investigator
Hannover Medical School
49 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CDR132L in people with Myocardial Infarction, Acute and Heart Failure, Left Sided, run by Cardior Pharmaceuticals GmbH at 49 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Poland, Netherlands, Spain, Germany, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in LVESVI (Left Ventricular End-systolic Volume Index) at Month 6 (time frame: Baseline (Day 1), Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05350969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.