Refractory Heart FailureNCT01758627
The Role of Peritoneal Dialysis in Patients With Refractory Heart Failure and Chronic Kidney Disease
A study testing Peritoneal dialysis (PD) in people with Refractory Heart Failure and Chronic Kidney Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
In patients with advanced heart failure (HF), systemic congestion is the main indication for hospitalization. Recent evidence has highlighted the role of fluid retention in the pathogenesis of renal dysfunction and subsequent diuretic resistance. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Refractory Heart Failure, Chronic Kidney Disease
- What is being tested?
- Peritoneal dialysis (PD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to 8 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least two non-planned admissions for acute heart failure (AHF), the last episode being in the past 6 months
- New York Heart Association (NYHA) functional class III/IV and left ventricular ejection fraction (LVEF) less than 40%
- Persistent congestion despite optimal loop diuretic therapy
- Presence of renal dysfunction [estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2] documented at least once in the last 6 months
Who cannot join
- < 20 years of age
- Pregnancy
- Unsuitable for PD (patients with major abdominal wall defects)
- Allergic to starch or other contraindication to icodextrin (5) End-stage renal disease (eGFR < 10 ml/min/1.73 m2) requring dialysis treatment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine
Seoul, 120-752
About this study
In patients with advanced heart failure (HF), systemic congestion is the main indication for hospitalization. Recent evidence has highlighted the role of fluid retention in the pathogenesis of renal dysfunction and subsequent diuretic resistance. Previous kidney disease, diuretic resistance, and progression of renal dysfunction often coexist in patients with HF and persistent volume overload. This clinical presentation represents the most extreme feature of the cardio-renal syndrome. However, available therapeutic options for this ominous condition are scarce and limited. Indeed, there are no data from randomized control trials using pharmacological interventions that support the beneficial effect on survival. Interestingly, intermittent ultrafiltration has recently emerged as an alternative therapeutic option for reducing volume overload in patients with refractory HF. Current literature suggests that it has potential advantages over standard medical treatment particularly in acute stages of HF. Among ultrafiltration methods, peritoneal dialysis (PD) has been preferred as an additional resource for the treatment of advanced congestive heart failure (CHF) compared with hemodialysis because it can provide a more physiological and continuous ultrafiltration. In fact, several studies showed that use of PD improved clinical functional class and hemodynamic parameters and reduced hospitalization rates in patients with CHF. Nevertheless, most studies were limited by retrospective analyses of small sample size, prospective observational design with no control group, or inclusion of patients with end-stage renal failure. Therefore, well-designed prospective randomized controlled studies are mandatory to confirm the effects of PD in these patients.
- Conditions
- Refractory Heart Failure, Chronic Kidney Disease
- Being tested
- Peritoneal dialysis (PD)
- Keywords
- Peritoneal dialysis,, chronic kidney disease,, refractory heart failure
- Medical subject headings
- Heart Failure, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal dialysis (PD)Drug
Also called PD exchanges will be customized depending on patient fluid status. At least one daily exchange of icodextrin PD solution will be provided to PD group.
PD exchanges will be customized depending on patient fluid status. At least one daily exchange of icodextrin PD solution will be provided to PD group.
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal dialysis group | No intervention | Not described |
| Conventional treatment group | Experimental | medical treatment such as diuretics Receives: Drug: Peritoneal dialysis (PD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of New York Heart Association (NYHA) functional class
Measured: at 0 (±1 week), 12 (±1 week), and 24 (±1 week) weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startDec 2013
- Primary completion8 Oct 2015
- Study completion8 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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
- 7 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
- NCT01758627
- Sponsor's protocol ID
- 4-2012-0750
- Status last verified
- Apr 2016
- First submitted
- 24 Dec 2012
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Peritoneal Dialysis in Patients With Refractory Heart Failure and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01758627
- Acronym / sponsor ID
- 4-2012-0750
- Conditions
- Refractory Heart Failure, Chronic Kidney Disease
- Keywords
- Peritoneal dialysis,, chronic kidney disease,, refractory heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- 8 Oct 2015 (actual)
- Study completion
- 8 Oct 2015 (actual)
- First posted
- 1 Jan 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.
In patients with advanced heart failure (HF), systemic congestion is the main indication for hospitalization. Recent evidence has highlighted the role of fluid retention in the pathogenesis of renal dysfunction and subsequent diuretic resistance. Previous kidney disease, diuretic resistance, and progression of renal dysfunction often coexist in patients with HF and persistent volume overload. This clinical presentation represents the most extreme feature of the cardio-renal syndrome. However, available therapeutic options for this ominous condition are scarce and limited. Indeed, there are no data from randomized control trials using pharmacological interventions that support the beneficial effect on survival. Interestingly, intermittent ultrafiltration has recently emerged as an alternative therapeutic option for reducing volume overload in patients with refractory HF. Current literature suggests that it has potential advantages over standard medical treatment particularly in acute stages of HF. Among ultrafiltration methods, peritoneal dialysis (PD) has been preferred as an additional resource for the treatment of advanced congestive heart failure (CHF) compared with hemodialysis because it can provide a more physiological and continuous ultrafiltration. In fact, several studies showed that use of PD improved clinical functional class and hemodynamic parameters and reduced hospitalization rates in patients with CHF. Nevertheless, most studies were limited by retrospective analyses of small sample size, prospective observational design with no control group, or inclusion of patients with end-stage renal failure. Therefore, well-designed prospective randomized controlled studies are mandatory to confirm the effects of PD in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peritoneal dialysis group | No intervention | – |
| Conventional treatment group | Experimental | Drug: Peritoneal dialysis (PD)medical treatment such as diuretics |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least two non-planned admissions for acute heart failure (AHF), the last episode being in the past 6 months
- New York Heart Association (NYHA) functional class III/IV and left ventricular ejection fraction (LVEF) less than 40%
- Persistent congestion despite optimal loop diuretic therapy
- Presence of renal dysfunction [estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2] documented at least once in the last 6 months
Key exclusion criteria (4 listed)
- < 20 years of age
- Pregnancy
- Unsuitable for PD (patients with major abdominal wall defects)
- Allergic to starch or other contraindication to icodextrin (5) End-stage renal disease (eGFR < 10 ml/min/1.73 m2) requring dialysis treatment
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 |
|---|---|---|
| Peritoneal dialysis (PD)Also: PD exchanges will be customized depending on patient fluid status. At least one daily exchange of icodextrin PD solution will be provided to PD group.PD exchanges will be customized depending on patient fluid status. At least one daily exchange of icodextrin PD solution will be provided to PD group. | Drug | Conventional treatment group |
Primary outcome
Changes of New York Heart Association (NYHA) functional class
Time frame: at 0 (±1 week), 12 (±1 week), and 24 (±1 week) weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peritoneal dialysis (PD) in people with Refractory Heart Failure and Chronic Kidney Disease, run by Yonsei University at 1 site in South Korea.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes of New York Heart Association (NYHA) functional class (time frame: at 0 (±1 week), 12 (±1 week), and 24 (±1 week) weeks)). 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 29 Mar 2019.