Congestive Heart FailureNCT01817803
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)
A study testing furosemide/no spironolactone, metolazone/no spironolactone and furosemid/spironolactone in people with Congestive Heart Failure, run by Yonsei University.
Trial summary
To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- furosemide/no spironolactone, metolazone/no spironolactone and furosemid/spironolactone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dyspnea at rest or minimal activity
- tachypnea (respiratory rate > 20/min) or rales or pulmonary edema on chest X-ray
- who need diuretics add over 40mg of daily furosemide dose
Who cannot join
- Hospitalization for acute heart failure decompensation
- cardiogenic shock (Systolic Blood Pressure < 80mmHg)
- Need or plan for renal replacement therapy (dialysis, kidney transplant)
- serum creatine level > 2.5mg/dl
- serum potassium (K+) > 5.5mg/dl
- daily spironolactone dose > 50mg
- previous thiazide or metolazone user
- 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
About this study
To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients
- Conditions
- Congestive Heart Failure
- Being tested
- furosemide/no spironolactone, metolazone/no spironolactone, furosemid/spironolactone, metolazone/spironolactone
- Keywords
- Heart failure, diuretics, kidney, glomerular filtration rate
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
furosemide/no spironolactoneDrug
furosemide (doubling previous furosemide dose)
metolazone/no spironolactoneDrug
metolazone (add 2.5mg qod)
furosemid/spironolactoneDrug
furosemide (doubling previous furosemide dose)+spironolactone (doubling previous spironolactone dose or add 12.5mg BID if previous non-user)
metolazone/spironolactoneDrug
metolazone (add 2.5mg qod)+ spironolactone (doubling previous spironolactone dose or add 12.5mg BID if previous non-user)
| Study group | Role | What they receive |
|---|---|---|
| 1) Add furosemide/no spironolactone | Active comparator | Not described Receives: Drug: furosemide/no spironolactone |
| 2) Add metolazone/no spironolactone | Active comparator | Not described Receives: Drug: metolazone/no spironolactone |
| 3) Add furosemide/spironolactone | Active comparator | Not described Receives: Drug: furosemid/spironolactone |
| 4) Add metolazone/spironolactone | Active comparator | Not described Receives: Drug: metolazone/spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy and safety of diuretics add-on strategy
- 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)
Measured: D+0, D+7, D+30, D+90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817803
- Sponsor's protocol ID
- 4-2013-0013
- Status last verified
- Feb 2014
- First submitted
- 20 Mar 2013
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01817803
- Acronym / sponsor ID
- 4-2013-0013
- Conditions
- Congestive Heart Failure
- Keywords
- Heart failure, diuretics, kidney, glomerular filtration rate
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1) Add furosemide/no spironolactone | Active comparator | Drug: furosemide/no spironolactone |
| 2) Add metolazone/no spironolactone | Active comparator | Drug: metolazone/no spironolactone |
| 3) Add furosemide/spironolactone | Active comparator | Drug: furosemid/spironolactone |
| 4) Add metolazone/spironolactone | Active comparator | Drug: metolazone/spironolactone |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- dyspnea at rest or minimal activity
- tachypnea (respiratory rate > 20/min) or rales or pulmonary edema on chest X-ray
- who need diuretics add over 40mg of daily furosemide dose
Key exclusion criteria (8 listed)
- Hospitalization for acute heart failure decompensation
- cardiogenic shock (Systolic Blood Pressure < 80mmHg)
- Need or plan for renal replacement therapy (dialysis, kidney transplant)
- serum creatine level > 2.5mg/dl
- serum potassium (K+) > 5.5mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| furosemide/no spironolactonefurosemide (doubling previous furosemide dose) | Drug | 1) Add furosemide/no spironolactone |
| metolazone/no spironolactonemetolazone (add 2.5mg qod) | Drug | 2) Add metolazone/no spironolactone |
| furosemid/spironolactonefurosemide (doubling previous furosemide dose)+spironolactone (doubling previous spironolactone dose or add 12.5mg BID if previous non-user) | Drug | 3) Add furosemide/spironolactone |
| metolazone/spironolactonemetolazone (add 2.5mg qod)+ spironolactone (doubling previous spironolactone dose or add 12.5mg BID if previous non-user) | Drug | 4) Add metolazone/spironolactone |
Primary outcome
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing furosemide/no spironolactone, metolazone/no spironolactone and furosemid/spironolactone in people with Congestive Heart Failure, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy and safety of diuretics add-on strategy (time frame: D+0, D+7, D+30, D+90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.