search
Back to results

Optimal Balance Alfapump® System Feasibility Study (OPTIMALBALANCE)

Primary Purpose

Heart Failure

Status
Withdrawn
Phase
Phase 1
Locations
Hungary
Study Type
Interventional
Intervention
Alfapump
Sponsored by
Sequana Medical N.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • 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:

    1. Treatment with diuretic therapy
    2. Treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) for at least 30 days
    3. Treatment with nitrates and/or vasodilators at the investigator's discretion
    4. Treatment with beta-blockers for at least 90 days
    5. Treatment with cardiac resynchronization therapy (CRT)
    6. 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

Sites / Locations

  • Military Hospital - State Health Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Alfapump

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2016
Last Updated
March 18, 2021
Sponsor
Sequana Medical N.V.
search

1. Study Identification

Unique Protocol Identification Number
NCT03032211
Brief Title
Optimal Balance Alfapump® System Feasibility Study
Acronym
OPTIMALBALANCE
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Change in company strategy
Study Start Date
December 31, 2017 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sequana Medical N.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Alfapump
Intervention Type
Device
Intervention Name(s)
Alfapump
Intervention Description
Implant Alfapump® System
Primary Outcome Measure Information:
Title
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Description
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.
Time Frame
Q1 2017 and Q3 2017

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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: 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
Facility Information:
Facility Name
Military Hospital - State Health Centre
City
Budapest
ZIP/Postal Code
1134
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Study cancelled, therefore not applicable at time of answering this remark.

Learn more about this trial

Optimal Balance Alfapump® System Feasibility Study

We'll reach out to this number within 24 hrs