Comparing Diuretic Strategies in Hospitalized Heart Failure

NCT03999216 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 51720
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

We will conduct a pragmatic randomized trial comparing whether using a combination of two types of diuretics (loop + thiazide) compared with using a single diuretic (loop only) will result in shorter hospital stays for patients hospitalized with heart failure.

Conditions

Heart Failure

Keywords

diuretics

Outcome Measures

Primary Outcomes (1)

• Hospital length of stay

  During hospitalization up to 90 days

Secondary Outcomes (1)

• Composite of all-cause rehospitalizations, emergency department visits, or death in the 30 days after hospital discharge.

  30 days

Study Arms (2)

Loop only

ACTIVE COMPARATOR

Participants will receive a loop diuretic for up to the first 72 hours of hospitalization. The specific drug, dose and route are left to the treating providers.

Drug: Loop Diuretics vs. loop + thiazide diuretics

Loop + Thiazide

ACTIVE COMPARATOR

Participants will receive a loop+thiazide diuretic for up to the first 72 hours of hospitalization. The specific drugs, doses and routes are left to the treating providers.

Drug: Loop Diuretics vs. loop + thiazide diuretics

Interventions

Loop Diuretics vs. loop + thiazide diuretics DRUG

Participants will receive the diuretic type as determined by the randomized group assignment starting within the first 24 hours of hospital admission and continuing for up to 72 hours. All other treatments are left to the discretion of the treatment team, as this is a pragmatic randomized trial.

Loop + Thiazide; Loop only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any adult (age ≥18 years) admitted to the Heart Failure Service at Stanford Health Care with an indication for treatment with a diuretic.

You may not qualify if:

• admission to the intensive care unit or cardiac care units
• maintenance dialysis on admission
• any mechanical circulatory support on admission
• history of heart transplant
• allergy / intolerance to loop or thiazide diuretics
• admission serum sodium \< 125 meq/L (from EPIC)
• admission serum potassium \< 3.0 meq/L (from EPIC)

Sponsors & Collaborators

• Stanford University: lead
• American Heart Association: collaborator

Study Sites (1)

Stanford Health Care

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Sodium Chloride Symporter Inhibitors

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Diuretics; Natriuretic Agents; Physiological Effects of Drugs

Study Officials

• Tara Chang, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine (Nephrology)

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: July 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)