Comparing Diuretic Strategies in Hospitalized Heart Failure

NCT ID: NCT03999216

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2024-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Loop only

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.

Group Type: ACTIVE_COMPARATOR

Loop Diuretics vs. loop + thiazide diuretics

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Loop Diuretics vs. loop + thiazide diuretics

Intervention Type: 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.

Interventions

Loop Diuretics vs. loop + thiazide diuretics

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. admission to the intensive care unit or cardiac care units

2. maintenance dialysis on admission

3. any mechanical circulatory support on admission

4. history of heart transplant

5. allergy / intolerance to loop or thiazide diuretics

6. admission serum sodium < 125 meq/L (from EPIC)

7. admission serum potassium < 3.0 meq/L (from EPIC)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Tara I-Hsin Chang

Associate Professor of Medicine (Nephrology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tara Chang, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Health Care

Palo Alto, California, United States

Countries

United States

Other Identifiers

51720

Identifier Type: -

Identifier Source: org_study_id