Recruiting
Phase 2

AC01

Sponsor:

AnaCardio AB

Code:

NCT07584967

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

AC01

Placebo

Study Details

Brief summary:

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.

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Study ID

NCT07584967

Start date

Nov 15, 2026

Status verified date

Nov, 2026

Completion date

Aug 30, 2028

Anticipated

Primary completion date

Jul 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • 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.
  • Chronic advanced HFrEF defined as:

  • 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.
  • Sinus rhythm or permanent, persistent, or paroxysmal atrial fibrillation flutter (AFF) (AFF at screening is capped at maximum 15% of participants enrolled) with mean resting heart rate of >=55 and <=90 beats per minute (bpm) at screening, and >=50 and <=95 bpm at randomization, regardless of rhythm.
  • NT-proBNP >=400 picograms per milliliter (pg/mL) in sinus rhythm and >=800 pg/mL in AFF at screening (confirmed by central laboratory).
  • Transvenous implantable cardioverter-defibrillator (ICD) for primary prevention with back-up pacing set at 40 bpm.
  • Treated with optimal, stable, medical therapy for HF consistent with prevailing local and international guidelines unless contraindicated or not tolerated, as judged and documented by the investigator.

Key Exclusion Criteria:

  • 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.
  • Uncontrolled diabetes mellitus, defined as Hemoglobin A1c (HbA1c) >=9.0% (>=75 millimoles per mole \[mmol/mol\]) at screening, or severe complications of diabetes.
  • Body weight <50 kilogram (kg) or body mass index (BMI) <18 kilograms per square meter (kg/m\^2) or >45 kg/m\^2 at screening.
  • Any of the following electrocardiogram (ECG) findings at screening: Corrected QT interval using Fridericia's formula (QTcF) >450 milliseconds (ms), 1st degree atrioventricular (AV) block with PQ >240 ms, or AV block 2nd or 3rd degree.
  • History of aborted cardiac arrest, sustained ventricular tachycardia, or Torsades-de Pointes, or congenital long QT syndrome. Family history of sudden cardiac death, unexplained death, long QT syndrome, or death from a primary dysrhythmia.
  • Cardiac resynchronization therapy, Cardiac Contractility Modulation, or pacemaker device other than the back-up pacing function of the ICD.
  • Mechanical hemodynamic support, kidney support, or ventilation within 7 days before randomization.
  • Treatment with i.v. inotropes, i.v. vasodilators, or i.v. vasopressors within 3 days before randomization.
  • Treatment with any i.v. diuretics or supplemental oxygen within 6 hours before randomization.
  • Use of any drugs or substances known to be strong inducers of Cytochrome P450 3A4 (CYP3A4) enzyme within 28 days before randomization or planned to be used during the study period or strong inhibitors of CYP3A4 within 7 days before randomization or planned to be used during the study period.
  • Use of any drug that is known to prolong the QT interval (for example, sotalol, dofetilide, macrolides, some antidepressants, and some antipsychotics) within 28 days before randomization or planned to be used during the study period.
  • Treatment changes in glucose lowering therapy within 28 days before randomization.
  • Estimated glomerular filtration rate (eGFR) <20 milliliters per minute per 1.73 square meters (mL/min/1.73 m2) according to the Chronic Kidney Disease Epidemiology Collaboration formula, planned renal replacement therapy within the next 6 months, or receiving dialysis at screening.
  • Serum potassium <3.5 or >5.2 milliequivalents per liter (mEq/L) at screening.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 \*upper limit of normal (ULN) or total bilirubin >2 \* ULN, or known cirrhosis, severe liver, or pancreatic disease at screening.
  • Use of any anti-arrhythmic drugs within 28 days before randomization or planned to be used during the study period, except for amiodarone, ivabradine, digoxin, and beta blockers.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AC01 3 mg

Participants will receive AC01 orally twice daily (BID) for 12 weeks.

experimental: AC01 1 mg

Participants will receive AC01 orally BID for 12 weeks.

placebo comparator: Placebo

Participants will receive matching placebo orally BID for 12 weeks.

Interventions

AC01

AC01 tablets for oral administration.

Placebo

AC01 matching placebo tablets for oral administration.

Primary outcome measure

  • Absolute Change from Baseline in Composite Echocardiography Z-Score at Week 12 [ Time Frame: Baseline and Week 12 ]

Central Contacts and Locations

Central contacts

Robert Edfors, MD, PhD

+46 760 017 020studyinfo@anacardio.com

Locations

Progressive MD, InvivoCure

Recruiting

Van Nuys, California, United States, 91405-2272

Nature Coast Clinical Research

Recruiting

Crystal River, Florida, United States, 34429

Chicago Cardiology Institute

Recruiting

Schaumburg, Illinois, United States, 60173

Capital Area Research, LLC - Camp Hill

Recruiting

Camp Hill, Pennsylvania, United States, 17011

Diex Recherche Sherbrooke

Recruiting

Sherbrooke, Québec (QC), Canada, J1L 0H8

Diex Recherche Trois-Rivières

Recruiting

Trois-Rivières, Canada, G9A 4P3

More Information

Sponsor

AnaCardio AB

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

  • Heart Diseases
  • Cardiovascular Diseases
  • Heart Failure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by AnaCardio AB on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.