A Prospective, Single-center, Open-label, Pilot Study to Compare the Effectiveness and Safety of Diuretics Add-On Strategy in Chronic Heart Failure Patients (DIOS 1)

February 17, 2014 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Withdrawn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

18 years to 73 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
  3. who need diuretics add over 40mg of daily furosemide dose

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. daily spironolactone dose > 50mg
  7. previous thiazide or metolazone user
  8. Age > 75 years old or poor compliance patients 9. allergy, adverse drug reaction, hypersensitivity to any kinds of diuretics 10. life expectancy < 6 months (e.g. metastatic malignancy, liver cirrhosis) 11. 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
Active Comparator: 1) Add furosemide/no spironolactone
Drug: furosemide/no spironolactone
furosemide (doubling previous furosemide dose)
Active Comparator: 2) Add metolazone/no spironolactone
Drug: metolazone/no spironolactone
metolazone (add 2.5mg qod)
Active Comparator: 3) Add furosemide/spironolactone
Drug: furosemid/spironolactone
furosemide (doubling previous furosemide dose)+spironolactone (doubling previous spironolactone dose or add 12.5mg BID if previous non-user)
Active Comparator: 4) Add metolazone/spironolactone
Drug: metolazone/spironolactone
metolazone (add 2.5mg qod)+ spironolactone (doubling previous spironolactone dose or add 12.5mg BID if previous non-user)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy and safety of diuretics add-on strategy
Time Frame: D+0, D+7, D+30, D+90
1) body weight change, symptoms & signs change, systemic impedance change 2) serum & urine creatinine change, serum & urine electrolyte change, biomarkers change, clinical outcomes ( all-cause mortality, all-cause rehospitalization, start of renal replacement therapy)
D+0, D+7, D+30, D+90

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

March 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 22, 2013

First Posted (Estimate)

March 25, 2013

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 17, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0013

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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