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Protocolized spot urine sodium guided diuretic therapy for Acute Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Acute Heart Failure+1 MoreProtocolized diuretic therapy - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new way to give diuretics to people with heart failure in the emergency room, using less medication while still keeping sodium levels low.

Eligible Conditions
  • Acute Heart Failure
  • Heart Failure

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Lysine Chloride
1
Bumetanide 1.25 mg
2
Protocolized Diuretic Therapy

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: At 30 days and at 90 days

180 days
Death and Readmission
Day 5
Congestion
Dyspnea score
72 hours after randomization
Improvement in global clinical status (GCS)
At 30 days
Hierarchical global rank composite outcome
Day 90
Readmission and all-cause death
At 7-day follow-up
Clinical congestion score
At 90 days
Heart Failure readmission and Cardiovascular death
At hospital discharge and 7-day follow-up
Natriuretic peptide levels
Day 5
Dyspnea
Day 14
Days of clinical benefit
Up to 90 days
Differences in Epithelial Sodium Channel (ENaC) levels Web results Differences in Epithelial sodium channel (ENaC) levels

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Lysine Chloride
1
Bumetanide 1.25 mg
3
Protocolized Diuretic Therapy

Trial Design

2 Treatment Groups

Protocolized spot urine sodium guided diuretic therapy
1 of 2
Guideline-based care
1 of 2

Active Control

484 Total Participants · 2 Treatment Groups

Primary Treatment: Protocolized spot urine sodium guided diuretic therapy · No Placebo Group · Phase 2

Protocolized spot urine sodium guided diuretic therapy
Drug
ActiveComparator Group · 1 Intervention: Protocolized diuretic therapy · Intervention Types: Drug
Guideline-based careNoIntervention Group · 1 Intervention: Guideline-based care · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 30 days and at 90 days

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
774 Previous Clinical Trials
600,633 Total Patients Enrolled
Sean P. Collins, MDPrincipal InvestigatorVanderbilt University Medical Center

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been admitted to the emergency department with a diagnosis of acute heart failure.
References

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