Congestive Heart FailurePhase 3PDinCHFNCT01124227
Peritoneal Dialysis in Congestive Heart Failure
A Phase 3 study testing icodextrin in people with Congestive Heart Failure, run by Martini Hospital Groningen at 1 site in Netherlands.
Trial summary
Rationale: End-stage congestive heart failure is a serious invalidating condition with a poor prognosis and increasing incidence. Non-randomized observations showed peritoneal dialysis (PD) in these patients to improve clinically from NYHA stadium III-IV to as low as NYHA stadium I-II. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- icodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2010to Sep 2017
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Refractory Left Ventricular Congestive Heart Failure: LVEF < 30%
- Diminished renal function: eGFR < 60 ml/min
- Clinically volume overloaded (Dyspnoea (NYHA III-IV), edema, and/or ascites)
- Hospitalization for CHF during the last 6 months
- Patient is on optimal cardiologic medical therapy, which has been stable for more than 4 weeks
- Suitable for PD
Who cannot join
- Hypotension (SBP < 100 mmHg / MAP < 70) mmHg
- Instable AP or recent (< 6 months) myocardial infarction.
- Contraindications for PD (e.g. visual handicap, social)
- Liver failure
- COPD Gold class IV
- Malignancy with life expectancy < 2 years
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- Non compliance
- No informed consent
- Poor mental health
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Symptomatic Improvement by Peritoneal Dialysis in Patients With End Stage Congestive Heart Failure
Rationale: End-stage congestive heart failure is a serious invalidating condition with a poor prognosis and increasing incidence. Non-randomized observations showed peritoneal dialysis (PD) in these patients to improve clinically from NYHA stadium III-IV to as low as NYHA stadium I-II. A randomized trial is needed to test whether PD improves symptoms in this condition and to find an optimal scheme.
Objective: To improve symptomatology in severe chronic failure patients. Study design: Open, parallel intervention trial comparing 2 schemes of peritoneal dialysis with icodextrin (Extraneal®) with standard medical therapy..
Read more
Study population: Patients with chronic refractory left ventricular congestive heart failure (LVEF < 30%, older than 18 years).
Intervention: Peritoneal dialysis with one (night) or two (night and day) dwells with icodextrin (Extraneal®).
Main study parameters/endpoints: Reduction in NYHA classification of symptomatic Congestive Heart Failure at 8 months after start of PD therapy. Burden of congestive heart failure: measured by reduction in unfavorable days (noted by patients in diaries and including days of hospitalization for CHF-deterioration and death).
- Conditions
- Congestive Heart Failure
- Being tested
- icodextrin
- Keywords
- Congestive Heart Failure, Peritoneal Dialysis, Symptomatic improvement, Renal function
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
icodextrinDrug
Also called Extraneal, RVG 21300
2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Sham comparator | Not described Receives: Drug: icodextrin |
| 2 Icodextrin PD changes / day | Active comparator | Not described Receives: Drug: icodextrin |
| 1 Icodextrin PD change/day | Active comparator | Not described Receives: Drug: icodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients in NYHA class I, II, III, or IV as measure of quality of life
Measured: 8 months
Secondary outcomes (1)
Quality of life measures
Reduction in unfavorable days. Short-Form 36. Minnesota Living with Heart failure Questionnaire. 6 minute walk test. (re)hospitalization. Survival. Medication optimalisation. Cardial: LVH. Renal: GFR/ERPF/FF; KIM-1, NGAL, NAG. Volume status: ECV (radioactive and bio-impedance). Neurohumoral and inflammatory parameters.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2016
- Study completionSep 2017
Why it stopped: Due to very specific inclusion criteria the anticipated number of patients was not reached. Inclusion stopped at N=26, allowing for analyzing primary outcomes.
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martini Hospital Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Roche BV Netherlands
- Responsible party
- Principal investigator, Wilbert Martien Theodoor Janssen, Martini Hospital Groningen
- Investigators
- Wilbert M Janssen, MD, PhD, Principal investigator, Martini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124227
- Sponsor's protocol ID
- PDinCHF
- Other IDs
- 2009-017711-15, 2009
- Acronym
- PDinCHF
- Status last verified
- Aug 2019
- First submitted
- 12 May 2010
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic Improvement by Peritoneal Dialysis in Patients With End Stage Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT01124227
- Acronym / sponsor ID
- PDinCHF / PDinCHF
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive Heart Failure, Peritoneal Dialysis, Symptomatic improvement, Renal function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to very specific inclusion criteria the anticipated number of patients was not reached. Inclusion stopped at N=26, allowing for analyzing primary outcomes.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Martini Hospital GroningenUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Roche BV Netherlands
- Study start
- Apr 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 17 May 2010 (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.
Rationale: End-stage congestive heart failure is a serious invalidating condition with a poor prognosis and increasing incidence. Non-randomized observations showed peritoneal dialysis (PD) in these patients to improve clinically from NYHA stadium III-IV to as low as NYHA stadium I-II. A randomized trial is needed to test whether PD improves symptoms in this condition and to find an optimal scheme.
Objective: To improve symptomatology in severe chronic failure patients. Study design: Open, parallel intervention trial comparing 2 schemes of peritoneal dialysis with icodextrin (Extraneal®) with standard medical therapy..
Study population: Patients with chronic refractory left ventricular congestive heart failure (LVEF < 30%, older than 18 years).
Intervention: Peritoneal dialysis with one (night) or two (night and day) dwells with icodextrin (Extraneal®).
Main study parameters/endpoints: Reduction in NYHA classification of symptomatic Congestive Heart Failure at 8 months after start of PD therapy. Burden of congestive heart failure: measured by reduction in unfavorable days (noted by patients in diaries and including days of hospitalization for CHF-deterioration and death).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Sham comparator | Drug: icodextrin |
| 2 Icodextrin PD changes / day | Active comparator | Drug: icodextrin |
| 1 Icodextrin PD change/day | Active comparator | Drug: icodextrin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- Refractory Left Ventricular Congestive Heart Failure: LVEF < 30%
- Diminished renal function: eGFR < 60 ml/min
- Clinically volume overloaded (Dyspnoea (NYHA III-IV), edema, and/or ascites)
- Hospitalization for CHF during the last 6 months
Key exclusion criteria (9 listed)
- Hypotension (SBP < 100 mmHg / MAP < 70) mmHg
- Instable AP or recent (< 6 months) myocardial infarction.
- Contraindications for PD (e.g. visual handicap, social)
- Liver failure
- COPD Gold class IV
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 |
|---|---|---|
| icodextrinAlso: Extraneal, RVG 213002000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis. | Drug | 1 Icodextrin PD change/day, 2 Icodextrin PD changes / day, Standard Care |
Primary outcome
Number of patients in NYHA class I, II, III, or IV as measure of quality of life
Time frame: 8 months
1 secondary outcome
Quality of life measures
Time frame: 8 months
Results and safety
The study was stopped early (reason given: Due to very specific inclusion criteria the anticipated number of patients was not reached. Inclusion stopped at N=26, allowing for analyzing primary outcomes.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 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.
Wilbert M Janssen, MD, PhD principal investigator
Martini Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing icodextrin in people with Congestive Heart Failure, run by Martini Hospital Groningen at 1 site in Netherlands.
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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 16 Aug 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to very specific inclusion criteria the anticipated number of patients was not reached. Inclusion stopped at N=26, allowing for analyzing primary outcomes.). Results are not available in the source record.
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?
Number of patients in NYHA class I, II, III, or IV as measure of quality of life (time frame: 8 months). 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 16 Aug 2019.