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Device

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

Study 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 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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time in days to first heart failure hospitalization following study enrollment compared between study arms
Secondary outcome measures
Improvement in Patient Global Assessment compared between study arms at 4, 12, 24, and 52 weeks versus baseline
Improvement in Quality of Life scores compared between study arms at 4, 12, 24, and 52 weeks versus baseline
NYHA functional class at 4, 12, 24, and 52 weeks versus baseline in the ICG study arm
+3 more

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.

Find a Location

Who is running the clinical trial?

CardioDynamicsLead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
Milton Packer, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
2 Previous Clinical Trials
2,243 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PREVENT-HF: Prevention of Heart Failure Events With Impedance Cardiography Testing
2007. "PREVENT-HF: Prevention of Heart Failure Events With Impedance Cardiography Testing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00409916.
All > Heart Failure With Preserved Ejection Fraction
~27 spots leftby Apr 2025
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