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GOAL-HF2NCT07584967

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

StatusRecruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 2 months later.

See at-risk trials from AnaCardio AB

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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Eligibility criteria shortened, about 29 words
    • Trial sites expanded: 0 → 14 locations
    • Secondary endpoints: details revised at 6 of 21 entries
  2. Start date: Sep 15, 2026 to Nov 15, 2026
    • Primary completion pushed from May 9, 2028 to Jul 30, 2028
    • Study completion pushed from Jun 9, 2028 to Aug 30, 2028
    v4
  3. Start date: Aug 15, 2026 to Sep 15, 2026
    • Primary completion date: Apr 22, 2028 to May 9, 2028
    • Study completion date: May 22, 2028 to Jun 9, 2028
    v3
  4. Eligibility criteria expanded, about 46 words
    • Secondary endpoints: details revised at 6 of 21 entries
    • Study description expanded, about 1 word
    v2
  5. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

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

Secondary (21)

Absolute Change from Baseline in LVSV at Week 12
Absolute Change from Baseline in LVEF at Week 12
Absolute Change from Baseline in LVESV at Week 12
Absolute Change From Baseline in LAVImin at Week 12
Absolute Change from Baseline in N-terminal prohormone of Brain Natriuretic Peptide (NT-proBNP)
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Absolute Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) at Week 12
Absolute Change From Baseline in Patient Global Impression of Severity (PGIS) at Week 12
Patient Global Impression of Change (PGIC) at Week 12
Number of Participants With Death, Cardiovascular Death, Hospitalization, Cardiovascular Hospitalization, Heart Failure Hospitalization, Heart Failure Events, Other Adjudicated Events, and Listed for Heart Transplantation
Change From Baseline in Guideline-directed Medical Therapy (GDMT) Use for HFrEF at Week 12
Absolute Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Number of Participants With Dialysis
Absolute Change from Baseline in Council on Nutrition Appetite Questionnaire (CNAQ) Total Score
Absolute Change From Baseline in New York Heart Association (NYHA) Class
AUC,ss: Area Under the Concentration-Time Curve at Steady State of AC01 and its Metabolite M6
Cmax,ss: Maximum Observed Concentration at Steady State of AC01 and its Metabolite M6
Tmax,ss: Time to Reach Maximum Concentration at Steady State
Ctrough: Trough concentration at steady state of AC01 and its Metabolite M6
Rac (Cmax): Accumulation Ratio of Cmax for AC01 and its Metabolite M6
Rac (AUC): Accumulation Ratio of AUC for AC01 and its Metabolite M6
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)

Arms and interventions

AC01 3 mgExperimental

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

AC01 1 mgExperimental

Participants will receive AC01 orally BID for 12 weeks.

PlaceboPlacebo comparator

Participants will receive matching placebo orally BID for 12 weeks.

Drugs: AC01

Other: Placebo

Sites

14 sites in 8 countries

United States 4, Bulgaria 3, Canada 2, Czechia 1, Poland 1, Slovakia 1, Spain 1, Sweden 1