Heart FailurePhase 1OPTIMALBALANCENCT03032211
Optimal Balance Alfapump® System Feasibility Study
A Phase 1 study testing Alfapump in people with Heart Failure, run by Sequana Medical N.V. at 1 site in Hungary.
Trial summary
1. Summary of Clinical Investigation A summary of the clinical investigation is provided below and includes the primary objective of the study, the safety and feasibility endpoints, the number of subjects to be enrolled, the study duration, the subject follow-up and the inclusion/exclusion criteria. 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Alfapump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteHungary
- Study dates
- 31 Dec 2017to 31 Dec 2020
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ≥ 18 years and < 80 years of age
- Patients exhibiting physical signs of excessive fluid retention (i.e. elevated JVD, peripheral edema, ascites, pulmonary edema, weight gain etc.)
- Patients with an eGFR by the Modification of Diet in Renal Disease (MDRD) of > 15 to < 60 mL/min/1.73m2
- Patients with a brain natriuretic peptide (BNP) ≥ 150 pg/mL and/or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥ 600 pg/mL at time of screening or BNP ≥ 100 pg/mL and/or NTproBNP ≥ 400 pg/mL
- Patients who have a Six Minute Walk Test (SMWT) exercise capacity between 100 and 400 meters
- Patients presenting with NYHA Class III or ambulatory NYHA Class IV heart failure who have been on optimal medical management (OMM) based on current heart failure practice guidelines and who are failing to respond to or cannot tolerate one or more of the following interventions:
Show all 33Show fewer
- Treatment with diuretic therapy
- Treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) for at least 30 days
- Treatment with nitrates and/or vasodilators at the investigator's discretion
- Treatment with beta-blockers for at least 90 days
- Treatment with cardiac resynchronization therapy (CRT)
- Treatment with an automatic implantable cardioverter defibrillator (AICD)
- Patients who demonstrate compliance with the current medical regimen as reported by the treating physician
- Enrollment Exclusion Criteria
- Patients presenting with acute decompensated heart failure requiring hospitalization for management of their symptoms (i.e. hospitalization for exacerbation of chronic heart failure manifested by signs and symptoms requiring intravenous and/or more aggressive therapy)
- Patients with ascites on physical examination resulting predominantly from right heart failure
- Patients who have an indication for and are candidates for CRT but who have not been treated with CRT
- Patients who have an indication for and are candidates for an AICD but who have not been implanted with an AICD
- Patients with reversible causes of heart failure which may be remedied by conventional surgery or other interventions
- Patients with an eGFR by MDRD < 15 or > 60 ml/min/1.73m2
- Patients with a body mass index (BMI) < 18 kg/m2or > 35 kg/m2
- Patients with severe pulmonary disease by history (i.e. severe chronic obstructive pulmonary disease, severe hypoxia or a pulmonary artery mean pressure >40 mm Hg)
- Patients who have experienced a myocardial infarction (MI) within the past 90 days
- Patients who have experienced a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 90 days
- Patients who have undergone cardiac surgery or other major surgery within the past 90 days
- Patients who are candidates for and require a concomitant surgical procedure [i.e. coronary artery bypass graft (CABG), valvular surgery, etc.
- Patients who are candidates for and require temporary or durable mechanical circulatory support [i.e. intra-aortic balloon pump (IABP), ventricular assist device (VAD), extracorporeal membrane oxygenation (ECMO)]
- Patients with confirmed untreated abdominal aortic aneurysm (AAA) > 5 cm in diameter diagnosed within the past six months
- Patients with active systemic or uncontrolled infections
- Patients who are pregnant (Note: Negative pregnancy test will be required in all women - Patients with known alcohol or illicit drug abuse or dependence within the previous three months
- Patients who are currently enrolled or who have participated in the past 30 days in another therapeutic and/or interventional clinical study
- Patients with technical obstacles that pose an inordinately high surgical risk in the judgment of the Investigator
- Patients who have any underlying condition that, in the opinion of the Investigator, would disqualify the patient for inclusion in the study, limit survival to less than one year, or not permit valid consideration
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Clinical Study of Osmotic Pump Treatment in Fluid Management to Achieve Optimal Fluid Balance in NYHA Class III and Ambulatory NYHA Class IV Heart Failure Patients Who Have an Estimated Glomerular Filtration Rate of > 15 to < 60 mL/Min/1.73m2
- Summary of Clinical Investigation
A summary of the clinical investigation is provided below and includes the primary objective of the study, the safety and feasibility endpoints, the number of subjects to be enrolled, the study duration, the subject follow-up and the inclusion/exclusion criteria.
- Primary Objective The primary objective of the study is to evaluate the safety and feasibility of the alfapump® System indication for use in the management of fluid in NYHA Class III and ambulatory NYHA Class IV heart failure patients who have an eGFR of > 15 to < 60 mL/min/1.73m2.
- Study Endpoints
- Primary Safety Endpoint The primary safety endpoint will be an assessment of the occurrence of adverse events (AEs) and serious adverse events (SAEs) related to:
- Surgical implant of the alfapump®
- Device malfunctions
- Dialysate infusion
- Secondary Safety Endpoints The secondary endpoint will be an assessment of:
- Time to first hospitalization related to fluid management after the activation of the alfapump® System and initiation of dialysate infusion has occurred
- Rate of occurrence of re-hospitalizations related to fluid management
- All-cause mortality
- Assessment of Feasibility for Fluid Management in Heart Failure Indication The feasibility of the alfapump® System for management of fluid in NYHA Class III and ambulatory NYHA Class IV heart failure patients with renal dysfunction will be assessed by the net fluid balance as measured by the ability of the alfapump® System to move more fluid to the bladder than dialysate instilled.
- Conditions
- Heart Failure
- Being tested
- Alfapump
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfapumpDevice
Implant Alfapump® System
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Alfapump Receives: Device: Alfapump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
4 weeks after the third patient implanted an initial safety review will be done and after the last patient completed 3 months of dialysate administration.
Measured: Q1 2017 and Q3 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start31 Dec 2017 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Change in company strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- • Prospective, non-randomized, open label, single-arm study to evaluate the safety and feasibility of the use of the alfapump® system in New York Heart Association (NYHA) Class III and ambulatory NYHA Class IV heart failure patients with a history of at least one hospitalization for fluid management within the previous year.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequana Medical N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032211
- Sponsor's protocol ID
- 2016-CHF-003
- Acronym
- OPTIMALBALANCE
- Status last verified
- Apr 2018
- First submitted
- 11 Aug 2016
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study cancelled, therefore not applicable at time of answering this remark.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Clinical Study of Osmotic Pump Treatment in Fluid Management to Achieve Optimal Fluid Balance in NYHA Class III and Ambulatory NYHA Class IV Heart Failure Patients Who Have an Estimated Glomerular Filtration Rate of > 15 to < 60 mL/Min/1.73m2
- ClinicalTrials.gov ID
- NCT03032211
- Acronym / sponsor ID
- OPTIMALBALANCE / 2016-CHF-003
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in company strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sequana Medical N.V.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 26 Jan 2017 (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.
- Summary of Clinical Investigation
A summary of the clinical investigation is provided below and includes the primary objective of the study, the safety and feasibility endpoints, the number of subjects to be enrolled, the study duration, the subject follow-up and the inclusion/exclusion criteria.
- Primary Objective The primary objective of the study is to evaluate the safety and feasibility of the alfapump® System indication for use in the management of fluid in NYHA Class III and ambulatory NYHA Class IV heart failure patients who have an eGFR of > 15 to < 60 mL/min/1.73m2.
- Study Endpoints
- Primary Safety Endpoint The primary safety endpoint will be an assessment of the occurrence of adverse events (AEs) and serious adverse events (SAEs) related to:
- Surgical implant of the alfapump®
- Device malfunctions
- Dialysate infusion
- Secondary Safety Endpoints The secondary endpoint will be an assessment of:
- Time to first hospitalization related to fluid management after the activation of the alfapump® System and initiation of dialysate infusion has occurred
- Rate of occurrence of re-hospitalizations related to fluid management
- All-cause mortality
- Assessment of Feasibility for Fluid Management in Heart Failure Indication The feasibility of the alfapump® System for management of fluid in NYHA Class III and ambulatory NYHA Class IV heart failure patients with renal dysfunction will be assessed by the net fluid balance as measured by the ability of the alfapump® System to move more fluid to the bladder than dialysate instilled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- • Prospective, non-randomized, open label, single-arm study to evaluate the safety and feasibility of the use of the alfapump® system in New York Heart Association (NYHA) Class III and ambulatory NYHA Class IV heart failure patients with a history of at least one hospitalization for fluid management within the previous year.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: AlfapumpAlfapump |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Males or females ≥ 18 years and < 80 years of age
- Patients exhibiting physical signs of excessive fluid retention (i.e. elevated JVD, peripheral edema, ascites, pulmonary edema, weight gain etc.)
- Patients with an eGFR by the Modification of Diet in Renal Disease (MDRD) of > 15 to < 60 mL/min/1.73m2
- Patients with a brain natriuretic peptide (BNP) ≥ 150 pg/mL and/or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥ 600 pg/mL at time of screening or BNP ≥ 100 pg/mL and/or NTproBNP ≥ 400 pg/mL
- Patients who have a Six Minute Walk Test (SMWT) exercise capacity between 100 and 400 meters
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AlfapumpImplant Alfapump® System | Device | Treatment |
Primary outcome
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Q1 2017 and Q3 2017
4 weeks after the third patient implanted an initial safety review will be done and after the last patient completed 3 months of dialysate administration.
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 22 Mar 2021.
- Individual participant dataSharing planned: Undecided. Study cancelled, therefore not applicable at time of answering this remark.
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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 Phase 1 study testing Alfapump in people with Heart Failure, run by Sequana Medical N.V. at 1 site in Hungary.
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 33 inclusion and 0 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 22 Mar 2021. 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 Hungary. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Occurrence of adverse events (AEs) and serious adverse events (SAEs) (time frame: Q1 2017 and Q3 2017). 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 22 Mar 2021.