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Clinical Trials/NL-OMON43294
NL-OMON43294
Completed
Phase 2

GENETIC-AF * A Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients with Heart Failure - GENETIC-AF

ARCA biopharma, Inc.0 sites60 target enrollmentTBD
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Conditionsatrial fibrillationirregular hearth rythm10007521

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
atrial fibrillation
Sponsor
ARCA biopharma, Inc.
Enrollment
60
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients must meet all of the following inclusion criteria to be eligible for randomization in this study.;1\. Age \* 18 years and \* 85 years at the Screening Visit.;2\. Weight \* 40 kg at the Randomization Visit.;3\. Possess the \*1389Arg/Arg genotype.;4\. History of heart failure with reduced left ventricle ejection fraction (HFREF).;a. LVEF \< 0\.50 assessed at any time during the previous 12 months of the Screening Visit.;5\. At least one symptomatic paroxysmal or persistent AF episode \* 180 days of the Screening Visit.;a. Qualifying AF episode may be documented by ECG, Holter, TTM, or implanted device. AF documented by implanted device must be a single episode \* 60 minutes in duration. Atrial flutter is not considered a qualifying AF episode.;b. Must have experienced AF symptoms \* 180 days of the Screening Visit, but these symptoms may overlap with HF symptoms, i.e. may be \*arrhythmic\* (e.g. palpitations, dizziness) or \*heart failure\* (e.g. breathlessness, fatigability) in nature.;6\. Clinically appropriate for ECV if AF/AFL is present at the Week 0 Visit, including:;a. Patients with AF/AFL at randomization determined by the Investigator to require ECV.;b. Patients in SR at randomization determined by the Investigator to require ECV if AF/AFL recurs.;7\. Receiving guideline indicated oral anticoagulation therapy at the Randomization Visit, which is considered optimal for stroke prevention in the opinion of the Investigator.;8\. Systolic blood pressure \> 90 mmHg and \< 150 mmHg at the Randomization Visit.;9\. Female of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Randomization Visit.;a. Female who is surgically sterile or post\-menopausal for at least 12 months is not considered to be of childbearing potential.;10\. Female of childbearing potential must agree to use a highly effective contraception for the duration of the trial and for at least 30 days following the last dose of study drug.;a. Female who is surgically sterile or post\-menopausal for at least 12 months is not considered to be of childbearing potential.;11\. Must agree not to participate in a clinical study involving another investigational drug or device throughout the duration of this study.;12\. Must be competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved ICF. Must sign the ICF prior to the initiation of any study procedure and not withdraw consent prior to the Randomization Visit.

Exclusion Criteria

  • •1\. NYHA Class IV symptoms at the Randomization Visit.
  • •2\. Significant fluid overload at the Randomization Visit, in the opinion of the Investigator. Evidence of significant fluid overload may included
  • •a. Mean jugular venous pressure above the clavicle at 90°.
  • •b. Liver congestion.
  • •c. Moist pulmonary rales post\-cough.
  • •d. Peripheral edema beyond 1\+ pedal not explained by local factors.
  • •3\. Permanent AF at the Screening Visit.
  • •a. Permanent AF is defined as an ongoing AF event 1 year or longer in duration in which there is no intervening evidence of SR.
  • •4\. More than two ECV procedures within 6 months of the Randomization Visit or if the most recent ECV within 6 months of the Randomization Visit failed to produce SR.
  • •5\. Use of any of the following \< 7 days of the randomization Visit:

Outcomes

Primary Outcomes

Not specified

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