Heart Failure With Preserved Ejection FractionPhase 2REMOD-REVERTNCT05953831
Reverse Remodeling Effects of CDR132L in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy
A Phase 2 study testing CDR132L in people with Heart Failure With Preserved Ejection Fraction, run by Cardior Pharmaceuticals GmbH.
Trial summary
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study including approximately 130 randomized HF patients with heart failure with mildly reduced or preserved ejection fraction (LVEF ≥45%), to assess efficacy and safety of CDR132L on reverse remodeling. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2024to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Provision of signed informed consent prior to any study-specific procedures.
- Male or female of non-childbearing potential patients age ≥40 and <85 years.
- Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrollment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrollment with at least intermittent need for diuretic treatment.
- Ejection fraction ≥45% (determined by echocardiography at site laboratory)
- Increased intraventricular wall thickness (≥11 mm for female and ≥12 mm for male patients by echocardiography at site laboratory)
- NT-proBNP > 300 pg/ml (sinus rhythm); >900 pg/ml (atrial fibrillation at time of screening/inclusion or documented with the last 6 months)
- BMI between 22 kg/m² and 45 kg/m².
Main Exclusion Criteria:
- Hemoglobin A1C (A1C) ≥10.5%
- eGFR <35 mL/min/1.73m²
- Systolic blood pressure (BP) <90 mmHg on 2 consecutive measurements at 5-minute intervals, at Screening.
- Systolic BP≥180 mmHg on 2 consecutive measurements at 5-minute intervals, at Screening.
- Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
- Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
About this study
Official title: Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of CDR132L on Reverse Cardiac Remodeling in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study including approximately 130 randomized HF patients with heart failure with mildly reduced or preserved ejection fraction (LVEF ≥45%), to assess efficacy and safety of CDR132L on reverse remodeling. In this study, patients with HFpEF (EF ≥50%) or HFmrEF (LVEF 45-49%) will be included.
- Being tested
- CDR132L, Placebo
- Keywords
- HFpEF, Heart failure, Cardiac Hypertrophy
- Medical subject headings
- Heart Failure, Cardiomegaly
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.
PlaceboDrug
Placebo to CDR132L
| Study group | Role | What they receive |
|---|---|---|
| CDR132L 4.52 mg | Experimental | Six times CDR132L 4.52 mg/kg body weight intravenous in single dose. Receives: Drug: CDR132L |
| Placebo | Placebo comparator | Six times Placebo intravenous in single dose. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular mass
Left ventricular mass measured by cardiac magnetic resonance imaging (indexed to the height in meters raised to the power of 2)
Measured: 6 months
Left atrial maximum volume
Left atrial maximum volume (measured by cardiac magnetic resonance imaging in end systole(indexed to the height in meters raised to the power of 2))
Measured: 6 months
Total cardiac extracellular volume
Total cardiac extracellular volume (mL) measured by cardiac magnetic resonance imaging
Measured: 6 months
Left atrial strain
Left atrial strain measured by cardiac magnetic resonance imaging
Measured: 6 months
Maximum left ventricular wall thickness
Maximum left ventricular wall thickness measured by cardiac magnetic resonance imaging
Measured: 6 months
Age-adjusted e' velocity
Age-adjusted e' velocity measured by doppler echocardiography. With e´velocity being the maximal velocity of mitral annular motion (E-wave).
Measured: 6 months
Global longitudinal strain
Global longitudinal strain measured by echocardiography
Measured: 6 months
E/e'
E/e' measured by doppler echocardiography to evaluate the LV filling pressure.
Measured: 6 months
Concentration of N-terminal pro B-type natriuretic peptide
Concentration measured as biomarker from blood samples.
Measured: 6 months
Concentration of high-sensitivity cardiac troponin T
Concentration measured as biomarker from blood samples.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start30 Apr 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Why it stopped: Transfer of study responsibility and planning
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardior Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953831
- Sponsor's protocol ID
- CDR132L-P2-06
- Acronym
- REMOD-REVERT
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of CDR132L on Reverse Cardiac Remodeling in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy
- ClinicalTrials.gov ID
- NCT05953831
- Acronym / sponsor ID
- REMOD-REVERT / CDR132L-P2-06
- Keywords
- HFpEF, Heart failure, Cardiac Hypertrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Transfer of study responsibility and planning
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cardior Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
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, double-blind, placebo-controlled study including approximately 130 randomized HF patients with heart failure with mildly reduced or preserved ejection fraction (LVEF ≥45%), to assess efficacy and safety of CDR132L on reverse remodeling. In this study, patients with HFpEF (EF ≥50%) or HFmrEF (LVEF 45-49%) will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDR132L 4.52 mg | Experimental | Drug: CDR132LSix times CDR132L 4.52 mg/kg body weight intravenous in single dose. |
| Placebo | Placebo comparator | Drug: PlaceboSix times Placebo intravenous in single dose. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 4.52 mg |
| PlaceboPlacebo to CDR132L | Drug | Placebo |
Primary outcome
Left ventricular mass
Time frame: 6 months
Left ventricular mass measured by cardiac magnetic resonance imaging (indexed to the height in meters raised to the power of 2)
Left atrial maximum volume
Time frame: 6 months
Left atrial maximum volume (measured by cardiac magnetic resonance imaging in end systole(indexed to the height in meters raised to the power of 2))
Total cardiac extracellular volume
Time frame: 6 months
Total cardiac extracellular volume (mL) measured by cardiac magnetic resonance imaging
Left atrial strain
Time frame: 6 months
Left atrial strain measured by cardiac magnetic resonance imaging
Maximum left ventricular wall thickness
Time frame: 6 months
Maximum left ventricular wall thickness measured by cardiac magnetic resonance imaging
Age-adjusted e' velocity
Time frame: 6 months
Age-adjusted e' velocity measured by doppler echocardiography. With e´velocity being the maximal velocity of mitral annular motion (E-wave).
Global longitudinal strain
Time frame: 6 months
Global longitudinal strain measured by echocardiography
E/e'
Time frame: 6 months
E/e' measured by doppler echocardiography to evaluate the LV filling pressure.
Concentration of N-terminal pro B-type natriuretic peptide
Time frame: 6 months
Concentration measured as biomarker from blood samples.
Concentration of high-sensitivity cardiac troponin T
Time frame: 6 months
Concentration measured as biomarker from blood samples.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CDR132L in people with Heart Failure With Preserved Ejection Fraction, run by Cardior Pharmaceuticals GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Left ventricular mass (time frame: 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.