Heart FailureRED DESERTNCT04116034
Alfapump Direct Sodium Removal (DSR) Feasibility Study
A study testing alfapump DSR system in people with Heart Failure and Congestive Heart Failure, run by Sequana Medical N.V. at 2 sites in 2 countries.
Trial summary
First in Human feasibility and sfafety study of the alfapump DSR system in the treatment of Heart failure subects resistant to diuretic therapy. Up to 10 subjects will be enrolled in up to 3 centres in Belgium and Georgia and will be iplanted with the alfapump DSR system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive Heart Failure, Cardiorenal Syndrome
- What is being tested?
- alfapump DSR system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Dec 2019to 15 Apr 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects > 18 years of age
- eGFR > 30ml/min/14.73m2
- Diagnosis of heart failure with one of the following: a. nt-proBNP > 400 pg/ml (or BNP > 100 pg/mp) and oral diuretic dose ≥ 80mg furosemide (or 20mg torsemide or 1mg bumetanide) OR b. Oral diuretic dose ≥ 120mg furosemide (or 30 mg torsemide or 1.5 mg bumetanide)
- Stable diuretic dose for 30 days
- Systolic blood pressure ≥ 100 mmHg
- Determined by treating provider to be at optimal volume status
Who cannot join
- Candidates for participation will be ineligible for the study if any of the following exclusion criteria apply:
- Proteinuria > 1g/day
- BMI > 40
- History of abdominal surgery or peritonitis
- Anemia with hemoglobin < 8g/dL
- Serum sodium < 135 mEq/L
Show all 16Show fewer
- Severe hyperkalemia or baseline plasma potassium > 4.5 mEq/L
- Significant other organ disease or comorbidities
- Hospitalization within 90 days
- Cirrhosis
- Hemodynamically significant stenotic valvular disease
- Active or recurrent urinary tract infection or history of renal transplant
- History of significant bladder dysfunction expected to interfere with ability of subject to tolerate DSR pumping into bladder
- Uncontrolled diabetes with frequent hyperglycemia or Type 1 diabetes
- Subject is currently participating in another clinical trial
- Subject is unable to comply with all required study follow-up procedures
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Alfapump DSR System in the Treatment of Diuretic Resistant Heart Failure Subjects
First in Human feasibility and sfafety study of the alfapump DSR system in the treatment of Heart failure subects resistant to diuretic therapy. Up to 10 subjects will be enrolled in up to 3 centres in Belgium and Georgia and will be iplanted with the alfapump DSR system. Subjects will undergo DSR titration during a 2 week hospitalisation period, and will continue titrated DSR therapy as outpatients for 4 more weeks.
Read the detailed description
Up to 10 subjects diagnosed with stable chronic heart failure (CHF) on high oral diuretic dose and an MDRD eGFR > 30ml/min/1.73m2 will undergo subcutaneous implantation of the alfapump DSR system (Day-13) and portacath system and participate in a 6 week interventional study. Prior to an inpatient study period, the subject will undergo a 40mg IV furosemide (or 1 mg IV bumetanide) diuretic challenge with timed biospecimen collection. On day 14 post-implant (Day 0), the subject will be admitted for a 14-day period in which diuretics will be withheld and subjects will be on a strict low-sodium (3g/day) diet with strict intake/output and all urine collected and samples saved for analysis. During the first 7 days (Day 0 - 6) subjects will be treated with 1000ml of DSR Infusate Monday, Wednesday, Friday administered to the peritoneal cavity through the subcutaneous peritoneal catheter. The infusate will remain in the peritoneal cavity for a 2 hour dwell time, then all fluid will be removed from the peritoneal cavity to the urinary bladder using the alfapump DSR system over the subsequent 8 hours. On day 7, subjects will be transitioned to a moderate to high salt diet given as the same low-sodium (3g/day) diet with supplementation with sodium chloride tablets (2g/day) (5g/day total sodium), as this will likely represent their typical home sodium intake. During this time, the optimal treatment protocol (frequency of administration and volume of DSR infusate administered) for individual subjects based on daily sodium balance, weight changes, and blood pressure will be created and tested over the next seven days in hospital (Day 7 - 13). Following the inpatient period, a second diuretic challenge will be conducted. Over the subsequent 28 days, diuretics will continue to be withheld with preferential maintenance of euvolemia through DSR and subjects will come into the clinic based on their tailored therapy schedule and undergo supervised DSR infusate administration. Addition of diuretic treatment will only be allowed if maximal DSR therapy has been instituted (DSR 7 days per week (i.e., including weekends) at 1.5L per session with dwell time of 4 hours) and/or holding diuretics until additional DSR can be utilized would represent a risk to the subject, as described in the CIP diuretic algorithm.
After the completion of the study period, the alfapump DSR therapy is halted and the subject undergoes a third diuretic challenge to quantify diuretic response. At this point oral diuretic therapy will be resumed. At the end of the study the alfapump can remain implanted and set to 'dormant' state after discussion and agreement between subject and investigator, and if there are no clinical, ethical or other reasons indicating explanation of the alfapump. Alternatively, the subject may elect to enroll into a low intensity follow-on study.
- Conditions
- Heart Failure, Congestive Heart Failure, Cardiorenal Syndrome, Volume Overload, Sodium Excess, Sodium Disorder
- Being tested
- alfapump DSR system
- Medical subject headings
- Heart Failure, Cardio-Renal Syndrome, Edema, Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alfapump DSR systemDevice
Infusion of sodium free Dextrose 10% into peritoneal cavity to remove sodium and fluid using principles of peritoneal dialysis, sodium and ultrafiltrate will be evacuated to the bladder by the alfapump
| Study group | Role | What they receive |
|---|---|---|
| DSR | Experimental | Up to 10 subjects will be treated with alfapump DSR system for a total treatment period of 59 days post-implantation Receives: Device: alfapump DSR system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety in-hospital - Device related
Rate of device related serious adverse events
Measured: Through Day 14 of treatment period
Safety in-hospital - therapy related
Rate of therapy related serious adverse events
Measured: Through Day 14 of treatment period
Safety in-hospital - procedure related
Rate of procedure related serious adverse events
Measured: Through Day 14 of treatment period
Safety during treatment period - device related
Rate of device related serious adverse events
Measured: through Day 42 of treatment period
Safety during treatment period - procedure related
Rate of procedure serious adverse events
Measured: through Day 42 of treatment period
Safety during treatment period - therapy related
Rate of therapy related serious adverse events
Measured: through Day 42 of treatment period
Secondary outcomes (2)
Feasibiity endpoint sodium balance in-hospital
Number of patients with neutral sodium balance (sodium intake equal to sodium output) in the absence of diuretic therapy during hospitalization period
Measured: through Day 14 of DSR therapy
Feasibility endpoint sodium balance during treatment period
Number of patients with neutral sodium balance (sodium intake equal to sodium output) in the absence of diuretic therapy in a titrated schedule during treatment period
Measured: Through Day 42 of DSR Therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start26 Dec 2019
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- up to 10 subjects will be enrolled to evaluate feasibility and safety of thealfapump DSR system
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequana Medical N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Jozef Bartunek, MD, Principal investigator, Onze Lieve Vrouw Hospital Aalst, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116034
- Sponsor's protocol ID
- 2019-CHF-005
- Acronym
- RED DESERT
- Status last verified
- May 2021
- First submitted
- 1 Oct 2019
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD data will be shared with other researchers
Publications
Rao VS, Ivey-Miranda JB, Cox ZL, Moreno-Villagomez J, Ramos-Mastache D, Neville D, Balkcom N, Asher JL, Bellumkonda L, Bigvava T, Shaburishvili T, Bartunek J, Wilson FP, Finkelstein F, Maulion C, Turner JM, Testani JM. Serial direct sodium removal in patients with heart failure and diuretic resistance. Eur J Heart Fail. 2024 May;26(5):1215-1230. doi: 10.1002/ejhf.3196. Epub 2024 Mar 31.
PubMed 38556717
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alfapump DSR System in the Treatment of Diuretic Resistant Heart Failure Subjects
- ClinicalTrials.gov ID
- NCT04116034
- Acronym / sponsor ID
- RED DESERT / 2019-CHF-005
- Conditions
- Heart Failure, Congestive Heart Failure, Cardiorenal Syndrome, Volume Overload, Sodium Excess, Sodium Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sequana Medical N.V.Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Study start
- 26 Dec 2019 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 4 Oct 2019 (actual)
- 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.
First in Human feasibility and sfafety study of the alfapump DSR system in the treatment of Heart failure subects resistant to diuretic therapy. Up to 10 subjects will be enrolled in up to 3 centres in Belgium and Georgia and will be iplanted with the alfapump DSR system. Subjects will undergo DSR titration during a 2 week hospitalisation period, and will continue titrated DSR therapy as outpatients for 4 more weeks.
Detailed description
Up to 10 subjects diagnosed with stable chronic heart failure (CHF) on high oral diuretic dose and an MDRD eGFR > 30ml/min/1.73m2 will undergo subcutaneous implantation of the alfapump DSR system (Day-13) and portacath system and participate in a 6 week interventional study. Prior to an inpatient study period, the subject will undergo a 40mg IV furosemide (or 1 mg IV bumetanide) diuretic challenge with timed biospecimen collection. On day 14 post-implant (Day 0), the subject will be admitted for a 14-day period in which diuretics will be withheld and subjects will be on a strict low-sodium (3g/day) diet with strict intake/output and all urine collected and samples saved for analysis. During the first 7 days (Day 0 - 6) subjects will be treated with 1000ml of DSR Infusate Monday, Wednesday, Friday administered to the peritoneal cavity through the subcutaneous peritoneal catheter. The infusate will remain in the peritoneal cavity for a 2 hour dwell time, then all fluid will be removed from the peritoneal cavity to the urinary bladder using the alfapump DSR system over the subsequent 8 hours. On day 7, subjects will be transitioned to a moderate to high salt diet given as the same low-sodium (3g/day) diet with supplementation with sodium chloride tablets (2g/day) (5g/day total sodium), as this will likely represent their typical home sodium intake. During this time, the optimal treatment protocol (frequency of administration and volume of DSR infusate administered) for individual subjects based on daily sodium balance, weight changes, and blood pressure will be created and tested over the next seven days in hospital (Day 7 - 13). Following the inpatient period, a second diuretic challenge will be conducted. Over the subsequent 28 days, diuretics will continue to be withheld with preferential maintenance of euvolemia through DSR and subjects will come into the clinic based on their tailored therapy schedule and undergo supervised DSR infusate administration. Addition of diuretic treatment will only be allowed if maximal DSR therapy has been instituted (DSR 7 days per week (i.e., including weekends) at 1.5L per session with dwell time of 4 hours) and/or holding diuretics until additional DSR can be utilized would represent a risk to the subject, as described in the CIP diuretic algorithm.
After the completion of the study period, the alfapump DSR therapy is halted and the subject undergoes a third diuretic challenge to quantify diuretic response. At this point oral diuretic therapy will be resumed. At the end of the study the alfapump can remain implanted and set to 'dormant' state after discussion and agreement between subject and investigator, and if there are no clinical, ethical or other reasons indicating explanation of the alfapump. Alternatively, the subject may elect to enroll into a low intensity follow-on study.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- up to 10 subjects will be enrolled to evaluate feasibility and safety of thealfapump DSR system
| Arm | Type | Receives |
|---|---|---|
| DSR | Experimental | Device: alfapump DSR systemUp to 10 subjects will be treated with alfapump DSR system for a total treatment period of 59 days post-implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects > 18 years of age
- eGFR > 30ml/min/14.73m2
- Diagnosis of heart failure with one of the following: a. nt-proBNP > 400 pg/ml (or BNP > 100 pg/mp) and oral diuretic dose ≥ 80mg furosemide (or 20mg torsemide or 1mg bumetanide) OR b. Oral diuretic dose ≥ 120mg furosemide (or 30 mg torsemide or 1.5 mg bumetanide)
- Stable diuretic dose for 30 days
- Systolic blood pressure ≥ 100 mmHg
Key exclusion criteria (16 listed)
- Candidates for participation will be ineligible for the study if any of the following exclusion criteria apply:
- Proteinuria > 1g/day
- BMI > 40
- History of abdominal surgery or peritonitis
- Anemia with hemoglobin < 8g/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 |
|---|---|---|
| alfapump DSR systemInfusion of sodium free Dextrose 10% into peritoneal cavity to remove sodium and fluid using principles of peritoneal dialysis, sodium and ultrafiltrate will be evacuated to the bladder by the alfapump | Device | DSR |
Primary outcome
Safety in-hospital - Device related
Time frame: Through Day 14 of treatment period
Rate of device related serious adverse events
Safety in-hospital - therapy related
Time frame: Through Day 14 of treatment period
Rate of therapy related serious adverse events
Safety in-hospital - procedure related
Time frame: Through Day 14 of treatment period
Rate of procedure related serious adverse events
Safety during treatment period - device related
Time frame: through Day 42 of treatment period
Rate of device related serious adverse events
Safety during treatment period - procedure related
Time frame: through Day 42 of treatment period
Rate of procedure serious adverse events
Safety during treatment period - therapy related
Time frame: through Day 42 of treatment period
Rate of therapy related serious adverse events
2 secondary outcomes
Feasibiity endpoint sodium balance in-hospital
Time frame: through Day 14 of DSR therapy
Feasibility endpoint sodium balance during treatment period
Time frame: Through Day 42 of DSR Therapy
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 28 May 2021.
- Derived from this study: PubMed 38556717Rao VS, Ivey-Miranda JB, Cox ZL, Moreno-Villagomez J, Ramos-Mastache D, Neville D, Balkcom N, Asher JL, Bellumkonda L, Bigvava T, Shaburishvili T, Bartunek J, Wilson FP, Finkelstein F, Maulion C, Turner JM, Testani JM. Serial direct sodium removal in patients with heart failure and diuretic resistance. Eur J Heart Fail. 2024 May;26(5):1215-1230. doi: 10.1002/ejhf.3196. Epub 2024 Mar 31.
- Individual participant dataSharing planned: No. No IPD data will be shared with other researchers
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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.
Jozef Bartunek, MD principal investigator
Onze Lieve Vrouw Hospital Aalst, Belgium
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alfapump DSR system in people with Heart Failure and Congestive Heart Failure, run by Sequana Medical N.V. at 2 sites in 2 countries.
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 6 inclusion and 16 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 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Georgia. 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?
Safety in-hospital - Device related (time frame: Through Day 14 of treatment period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04116034, which also lists 1 linked publication.
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 28 May 2021.