400 Participants NeededMy employer runs this trial

AC01 for Heart Failure

(GOAL-HF2 Trial)

Recruiting at 13 trial locations
RE
Overseen ByRobert Edfors, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AnaCardio AB
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for adults with chronic heart failure (diagnosed at least 6 months ago) whose heart's pumping ability is reduced (LVEF ≤35%). Participants must have stable treatment, specific heart rhythms and rates, and certain blood test results. Some types of irregular heartbeat are limited in the study.

Inclusion Criteria

I have an ICD implanted for primary prevention with pacing set at 40 bpm.
My heart's pumping ability was measured at 5% or less over 6 months ago.
My heart's pumping ability (LVEF) has not been above 35% in recent tests.
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • AC01

Trial Overview

The study compares two doses of a new drug called AC01 to a placebo over 12 weeks to see if AC01 is safe and effective for people with advanced chronic heart failure. Participants are randomly assigned to one of the groups.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: AC01 3 mgExperimental Treatment1 Intervention
Group II: AC01 1 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AnaCardio AB

Lead Sponsor

Trials
1
Recruited
80+