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Reverse Remodeling Effects of CDR132L in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Reverse Remodeling Effects of CDR132L in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy

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

NCT05953831•Cardior Pharmaceuticals GmbH

View on ClinicalTrials.gov

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. In this study, patients with HFpEF (EF ≥50%) or HFmrEF (LVEF 45-49%) will be included.

Eligibility

Age

40 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of signed informed consent prior to any study-specific procedures.
•2. Male or female of non-childbearing potential patients age ≥40 and \<85 years.
•3. 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.
•4. Ejection fraction ≥ 45% (determined by echocardiography at site laboratory)
•5. Increased intraventricular wall thickness (≥11 mm for female and ≥12 mm for male patients by echocardiography at site laboratory)
•6. NT-proBNP \> 300 pg/ml (sinus rhythm); \>900 pg/ml (atrial fibrillation at time of screening/inclusion or documented with the last 6 months)
•7. BMI between 22 kg/m² and 45 kg/m².

Exclusion Criteria

•1. Hemoglobin A1C (A1C) ≥10.5%
•2. eGFR \<35 mL/min/1.73m²
•3. Systolic blood pressure (BP) \<90 mmHg on 2 consecutive measurements at 5-minute intervals, at Screening.
•4. Systolic BP≥180 mmHg on 2 consecutive measurements at 5-minute intervals, at Screening.
•5. Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
•6. Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.

Key Dates

Start Date

April 1, 2024

Primary Completion Date

September 1, 2025

Completion Date

September 1, 2025

Last Updated

January 9, 2026

Conditions

Heart Failure With Preserved Ejection Fraction

Interventions

CDR132L

DRUG

Placebo

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Reverse Remodeling Effects of CDR132L in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy

Inclusion Criteria

Exclusion Criteria

Prospective Evaluation of AI-ECG for SHD Detection

A Study Of CS Reducer For Symptomatic Heart Failure With HFpEF And CMD

A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Treating Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: Ablation or Medication

Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

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