ICG Arm for Congestive Heart Failure

Phase 4

Waitlist Available

Led By Milton Packer, MD

Research Sponsored by CardioDynamics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

The purpose of this study is to determine whether outpatient therapeutic management guided by impedance cardiography (ICG), in addition to standard clinical assessment, will result in a longer time in days to the first heart failure hospitalization than therapy guided by clinical assessment alone.

Eligible Conditions

Congestive Heart Failure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ICG ArmActive Control1 Intervention

In the ICG Arm, the treating clinician will adjust therapy according to the clinical assessment of signs and symptoms of heart failure, in addition to the ICG hemodynamic information obtained from the printed report.

Group II: Standard Care ArmPlacebo Group1 Intervention

In the Standard Care Arm, the treating clinician will adjust therapy according only to the clinical assessment of signs and symptoms of heart failure since the ICG information is blinded to the treating clinician.

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