A Prospective, Single-center, Randomized, Controlled, Open-label, Pilot Study to Compare the Effectiveness and Safety of DIuretics Add-On Strategy in Acute Decompensated Heart Failure Patients (DIOS II)

September 5, 2016 updated by: Yonsei University
To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. dyspnea at rest or minimal activity
  2. tachypnea (respiratory rate > 20/min) or rales or pulmonary edema on chest X-ray

Exclusion Criteria:

  1. hospitalization for acute heart failure decompensation
  2. cardiogenic shock (Systolic Blood Pressure < 80mmHg)
  3. Need or plan for renal replacement therapy (dialysis, kidney transplant)
  4. serum creatine level > 2.5mg/dl
  5. serum potassium (K+) > 5.5mg/dl
  6. Age > 80 years old or poor compliance patients
  7. allergy, adverse drug reaction, hypersensitivity to any kinds of diuretics
  8. life expectancy < 6 months (e.g. metastatic malignancy, liver cirrhosis)
  9. pregnancy or women at age of childbearing potential

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Add furosemide/no spironolactone
Drug: Furosemide
furosemide (doubling previous furosemide dose)
Experimental: Add metolazone/no spironolactone
Drug: metolazone
metolazone (add 2.5mg qod)
Experimental: Add furosemid/spironolactone
Drug: furosemid/spironolactone
spironolactone (doubling previous spironoalctone dose or add 12.5mg BID if previous non-user)
Experimental: Add metolazone/spironolactone
Drug: metolazone/spironolactone
no spironolactone (maintaining previous spironolactone dose or not add spironolactone if previous non-user)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urine output change
Time Frame: from admission to Hospital Day (HOD)#4
efficacy of diuretics add-on therapy, urine output change
from admission to Hospital Day (HOD)#4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum creatinine change
Time Frame: from admission to HOD#4
safety of diuretics add-on therapy, serum creatinine change
from admission to HOD#4

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
body weight change
Time Frame: from admission to HOD#4
body weight change, symptoms & signs change
from admission to HOD#4
urine creatinine change
Time Frame: from admission to HOD#4
urine creatinine change, serum & urine electrolyte change, biomarkers change
from admission to HOD#4
clinical outcomes
Time Frame: at 90 days after discharge
clinical outcomes ( all-cause mortality, all-cause rehospitalization, start of renal replacement therapy)
at 90 days after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

January 26, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 5, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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