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Phase Ib/IIa Trial With AC01 in Patients With HFrEF | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Phase Ib/IIa Trial With AC01 in Patients With HFrEF

Randomized, Double-blind, Multiple Ascending Dose, Placebo-controlled, Safety, Tolerability, Efficacy, Pharmacokinetic (PK) and Pharmacodynamic (PD) Phase Ib/IIa Clinical Trial With AC01 in Patients With HFrEF

NCT05642507•AnaCardio AB

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo-controlled two-part study with a multiple escalating dose phase followed by a cohort expansion phase to assess safety, tolerability, pharmacokinetics and pharmacodynamics of AC01 in patients with heart failure with reduced ejection fraction (HFrEF).

Detailed Description

During the dose escalation phase, patients will be given AC01 orally twice daily for seven days. In the cohort expansion phase, patients will be given AC01 orally twice daily for 28 days at dose levels selected on the basis of results of the dose escalation phase.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female out-patients of any ethnicity, between 18-80 years (inclusive), with stable HFrEF.
•Chronic HF for at least 6 months duration defined by history with current NYHA class II-III severity.
•LVEF ≤40% by TTE more than 6 months before screening and again at screening (screening measurement confirmed by echocardiography core lab).
•Sinus rhythm with mean resting heart rate 55-90 bpm.
•Cardiac Index 0.5-2.4 measured by Innocor at screening and Day -1. Screening measurement confirmed by core lab.
•Transvenous ICD for primary prevention in place and active (as long as it is not subcutaneous).
•Optimal guideline-based medical therapy for HFrEF as judged by the Investigator, at stable doses for ≥2 weeks with no intention to change dosing during trial duration.

Exclusion Criteria

•Any cardiac rhythm that does or could interfere with ECG or TTE interpretation, including but not limited to permanent or persistent atrial fibrillation or flutter or paroxysmal atrial fibrillation or flutter with an episode in the last 3 months, frequent premature ventricular contractions, or atrial or ventricular pacing
•Ongoing or planned mechanical circulatory support, treatment with any IV vasoactive drugs (vasodilators, inotropes, or vasopressors) or diuretics, and/or dialysis or hemofiltration or ultrafiltration.
•Probable alternative explanations for symptoms or signs (e.g., but not limited to, known primary cardiomyopathy \[hypertrophic, constrictive, restrictive, infiltrative, congenital\]). Primary uncorrected hemodynamically significant valve disease, right-sided HF not due to left-sided HF.
•History of aborted cardiac arrest and/or ICD for secondary prevention.
•Hospitalized for HF or received IV diuretics, vasodilators, or inotropes for HF ≤30 days.
•Clinical diagnosis of acute coronary syndrome or stroke ≤30 days.
•PCI or percutaneous valve intervention ≤30 days or planned.
•Angina pectoris ≤30 days.
•Any cardiovascular procedure planned during study duration.
•Hospitalized or unplanned visit to the emergency department for any reason in last 30 days; patient is eligible 30 days from discharge from hospital.
+6 more criteria

Locations (13)

Spedali Civilia di Brescia

Brescia, Italy

Azienda Sanitaria Universitaria Integrata

Trieste, Italy

Amsterdam University Medical Centre

Amsterdam, Netherlands

University Medical Centre Groningen/ICON

Groningen, Netherlands

Maastricht Heart and Vascular Center

Maastricht, Netherlands

Erasmus Medical Centre

Rotterdam, Netherlands

Sahlgrenska University Hospital

Gothenburg, Sweden

Skånes Universitetssjukhus Lund

Lund, Sweden

Karolinska University Hospital

Stockholm, Sweden

Ninewells Hospital and Medical School

Dundee, United Kingdom

Key Dates

Start Date

February 23, 2023

Primary Completion Date

October 27, 2025

Completion Date

October 27, 2025

Last Updated

November 17, 2025

Enrollment

ACTUAL participants

Conditions

Heart Failure With Reduced Ejection Fraction

Interventions

AC01

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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: November 17, 2025Data 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

Phase Ib/IIa Trial With AC01 in Patients With HFrEF

Inclusion Criteria

Exclusion Criteria

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