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A Study to Evaluate the Safety and Efficacy of AC01 Compared to Placebo in Participants With Chronic Heart Failure

ConditionHeart Failure With Reduced Ejection Fraction (HFrEF)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAnaCardio AB

About this trial

The primary purpose of the study is to evaluate the safety and efficacy of 2 doses of AC01 compared to placebo over 12 weeks in participants with chronic advanced HFrEF.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

History of Chronic Heart Failure (CHF) diagnosed greater than or equal to (>=6) months before screening, and in NYHA Class II to IV at screening.

LVEF less than or equal to (<=) 35 percentage (%) by local reading >=6 months before screening or a record of LVEF qualitatively described as severely reduced or moderately-severely reduced >=6 months before screening, and

LVEF <=35% at the screening echocardiography (confirmed by core lab), and

no known LVEF greater than (>) 35% (or qualitatively described as less than moderately-severely reduced) between the 2 readings.

Disqualifiers

Any acute or serious co-morbid condition that could lead to premature termination of study participation or interfere with the measurement or interpretation of the efficacy and safety assessments in the study.

Admitted to hospital with the primary reason of HF within 24 hours before randomization or currently hospitalized with the primary reason of HF for more than 10 days. Current hospitalization (>24 hours and <=10 days) is capped at a maximum of 15% of participants enrolled.

Acute coronary syndrome, stroke or transient ischemic attack, severe ventricular arrhythmia, or major cardiac intervention, percutaneous coronary intervention, valvuloplasty/other cardiac valve repair or implantation, or cardiac surgery within 60 days before randomization.

Systolic blood pressure >130 or ˂90 millimeters of mercury (mmHg) at screening, or >140 or ˂85 mmHg at randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AC01

    Drug

    AC01 tablets for oral administration.

  • Placebo

    Other intervention

    AC01 matching placebo tablets for oral administration.

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: AC01 3 mgExperimental treatment 1 intervention
Group B: AC01 1 mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Absolute Change from Baseline in Composite Echocardiography Z-Score at Week 12

The composite echocardiography Z-score integrates left ventricular stroke volume (LVSV), left ventricular end systolic volume (LVESV), left ventricular ejection fraction (LVEF), and left atrial minimal volume index (LAVImin).

Time frame
Baseline and Week 12

Secondary outcomes

1

Absolute Change from Baseline in LVSV at Week 12

Time frame
Baseline and Week 12
2

Absolute Change from Baseline in LVEF at Week 12

Time frame
Baseline and Week 12
3

Absolute Change from Baseline in LVESV at Week 12

Time frame
Baseline and Week 12
4

Absolute Change From Baseline in LAVImin at Week 12

Time frame
Baseline and Week 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AnaCardio AB

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: