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Comparing Diuretic Strategies in Hospitalized Heart Failure

Primary Purpose

Heart Failure

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Loop Diuretics vs. loop + thiazide diuretics

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring diuretics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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)

Sites / Locations

Stanford Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Loop only

Loop + Thiazide

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hospital length of stay

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03999216

First Posted

June 24, 2019

Last Updated

April 10, 2023

Sponsor

Stanford University

Collaborators

American Heart Association

1. Study Identification

Unique Protocol Identification Number

NCT03999216

Brief Title

Comparing Diuretic Strategies in Hospitalized Heart Failure

Official Title

Creating a Platform for Point-of-Care Pragmatic Clinical Trials: Comparing Diuretic Strategies in Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Due to administrative and logistical barriers this trial has been withdrawn.

Study Start Date

July 2023 (Anticipated)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

diuretics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Loop only

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Loop + Thiazide

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Loop Diuretics vs. loop + thiazide diuretics

Intervention Description

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.

Primary Outcome Measure Information:

Title

Hospital length of stay

Time Frame

During hospitalization up to 90 days

Secondary Outcome Measure Information:

Title

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

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tara Chang, MD, MS

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford Health Care

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparing Diuretic Strategies in Hospitalized Heart Failure

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