A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF) (NCT04680026)
A Phase 2, Two-Stage, Serial Cohort Dose Escalation and Expansion Study of a Single Intravenous Infusion of HBI 3000 for the Conversion of Atrial Fibrillation (AF) of Recent Onset
🩺 Plain-English Summary (8th-Grade Level)
This Phase 2 study is a two-stage, serial cohort dose escalation and expansion study of a single 30-minute (IV) infusion of HBI-3000 for the conversion of patients with recent-onset atrial fibrillation (AF). Stage A is open label and all patients will receive HBI-3000. In each of three dose cohorts, up to 10 patients will receive HBI-3000 by IV infusion (30 minutes). Three different dose levels are planned to be administered serially, lowest to highest, with assessment of safety, tolerability, and efficacy prior to proceeding to the next dose level group. Following Stage A, the iDMC will recommend up to two doses of HBI-3000 to be further explored in Stage B. Stage B is a serial, randomized, double-blind and placebo-controlled cohort of two different doses of HBI-3000, with a dose decision after the first cohort. Stage B will be powered to show a difference between HBI-3000 and placebo in conversion rate at each of the two dose levels.
Who can join: Review the eligibility criteria below.
Location: NCH Research Institute — Naples, Florida
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- NCH Research Institute — Naples, Florida
- Prairie Education & Research — Springfield, Illinois
- North Mississippi Medical Center — Tupelo, Mississippi
- CHRISTUS Trinity Mother Frances Hospital - Tyler — Tyler, Texas
- University Clinical Center of the Republic of Srpska — Banja Luka,
- Montreal Heart Institute — Montreal, Quebec
- Centre hospitalier de L'Universite de Montral (CHUM) — Montreal, Quebec
- Centre integre de sante et de services sociaux de Lanaudiere - Hopital Pierre-Le Gardeur — Terrebonne, Quebec
- Waikato Hospital — Hamilton,
- Wellington Regional Hospital — Wellington,
- Niš University Clinical Center — Niš, Bulevar Doktora
- University Clinical Center of Serbia — Belgrade,
- Dedinje Institute for Cardiovascular Diseases — Belgrade,
- University Hospital Medical Center Bezanijska kosa — Belgrade,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Atrial Fibrillation
- CHAMPION-AF Clinical Trial — Birmingham, Alabama
- Reversal of Atrial Substrate to Prevent Atrial — Calgary, Alberta
- Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients — Rochester, New York
- REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing: A Sub-Study of the REAL AF Registry — Chandler, Arizona
- Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF) — Cleveland, Ohio
- Liraglutide Effect in Atrial Fibrillation — Miami, Florida
Explore by condition: All Atrial Fibrillation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.