Heart FailureNCT04589065
SCD for CRS in Congestive Heart Failure (CHF) (No Left Ventricular Assist Device)
A study testing Selective Cytopheretic Device in people with Heart Failure and Chronic Systolic Heart Failure, run by Lenar Yessayan at 1 site in United States.
Trial summary
The purpose of this clinical trial is to see if a new device (SCD) is safe and if it can reduce damage to the kidney enough to allow medications to work to improve heart and kidney function for use in patients that have moderate to severe heart failure and is at least in part due to heart failure and it not responding… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Heart Failure, Chronic Systolic Heart Failure, Renal Failure
- What is being tested?
- Selective Cytopheretic Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2025to Dec 2027
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary hospitalization for acute decompensated chronic systolic heart failure as defined:
- Left ventricular ejection fraction ≤35% as confirmed by baseline imaging procedure.
- New York Heart Association (NYHA) class III or IV chronic (≤ 90 days) systolic heart failure, with failure to respond to optimal medical therapy (beta blocker, Angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB) or valsartan/sacubitril, aldosterone antagonist, unless not tolerated or contraindicated, and loop diuretic, as needed) for 45 of the last 60 days.
- Baseline Estimated Glomerular Filtration Rate (eGFR)** ≥ 40 ml/min/1.73 m2 (baseline defined as the highest known eGFR within 90 days of study enrollment)
- Worsening renal failure (WRF), defined for the purposes of this study as increase serum creatinine ≥ 0.5 mg/dL from baseline (baseline defined as the lowest known serum creatinine within 90 days of study enrollment)
- Cardiorenal syndrome is the most likely explanation for WRF
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- Persistent signs and /or symptoms of congestion (peripheral edema, dyspnea, pulmonary rales, neck vein distension) despite optimal medical therapy including intravenous diuretic therapy and an estimated need for greater than 5 kg. of fluid removal. For the purposes of this study, optimal intravenous diuretic therapy is defined as:
- Furosemide equivalent total daily dose of 240 mg (furosemide 40mg=1mg bumetanide)
- Furosemide equivalent dose given either as a single or multiple intravenous bolus or continuous infusion
- A furosemide equivalent total daily dose <240 mg if the dose has resulted in >3000 ml urine output/24 hours
Who cannot join
- Prior sensitivity to dialysis device components
- Individual with known hypersensitivity to citrate
- Bacteremia or possible infection, as evidence by fever, white blood cell count > 10,000/microliter, or any other signs of acute or chronic infection, and any patient receiving antibiotic or antiviral therapy.
- Active malignancy requiring chemotherapy, biological therapy or radiation therapy.
- The use of intravenous iodinated contrast agent within the prior 72 hours or the anticipated use of such an agent during SCD therapy.
- Need for intravenous vasopressor (i.e., phenylephrine, vasopressin), intravenous. vasoconstricting inotrope (i.e., norepinephrine or epinephrine) or dopamine > 3 mcg/kg/min. (Note: use of vasodilating inotropes [i.e., dobutamine and milrinone] or dopamine at ≤ 3 mcg/kg/min will not preclude study inclusion).
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- Persistent systolic blood pressure (SBP) < 80 mmHg.
- White blood cell (WBC)<4000/microliter.
- Platelets < 50,000/microliter.
- Serum creatinine > 4 mg/dL or receiving dialysis / continuous renal replacement therapy (CRRT)
- Acute coronary syndrome within the past month.
- Women who are pregnant, breastfeeding a child, or trying to become pregnant.
- Subject not able to sign informed consent.
- Use of any other investigational drug or device within the previous 30 days
- Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical studies where only measurements and/or samples are taken (i.e., no test device or test drug used) are allowed to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) to Treat Patients With NYHA Stage III or IV Heart Failure (HF) With Persistent Congestion and Worsening Renal Function as a Result of Cardiorenal Syndrome (CRS) That is Resistant to Optimal Medical Therapy Including Loop Diuretics
The purpose of this clinical trial is to see if a new device (SCD) is safe and if it can reduce damage to the kidney enough to allow medications to work to improve heart and kidney function for use in patients that have moderate to severe heart failure and is at least in part due to heart failure and it not responding to standard medical therapy. The SCD is a cartridge used with a commercial hemodialysis unit.
Participants will be enrolled in the clinical trial once eligibility is confirmed. In addition to clinical assessments and laboratory testing participants will have surface echocardiograms during the trial. The SCD treatment will take place for 4 hours on day 1, 3, and 5 while on hemodialysis.
- Being tested
- Selective Cytopheretic Device
- Keywords
- Hospitalized
- Medical subject headings
- Heart Failure, Renal Insufficiency, Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Cytopheretic DeviceDevice
SCD therapy will take place for 4 hours on day 1, 3, and 5 while on hemodialysis treatment. Participants will be continue to be followed until 30 days after the last SCD treatment.
| Study group | Role | What they receive |
|---|---|---|
| Selective Cytopheretic Device | Experimental | Not described Receives: Device: Selective Cytopheretic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Cardiac Function - Left Ventricular Ejection Fraction
This will be assessed by surface echocardiography.
Measured: up to 4 weeks following last SCD treatment
Secondary outcomes (2)
Improved renal function as measured by serum creatinine
Measured: up to 4 weeks following the last SCD therapy
Improved renal function as measured by blood urea nitrogen (BUN)
Measured: up to 4 weeks following the last SCD therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study startSep 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Recruitment on hold pending amendment approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lenar Yessayan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lenar Yessayan, University of Michigan
- Investigators
- Keith Aaronson, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589065
- Sponsor's protocol ID
- HUM00178335
- Status last verified
- Sep 2024
- First submitted
- 8 Oct 2020
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) to Treat Patients With NYHA Stage III or IV Heart Failure (HF) With Persistent Congestion and Worsening Renal Function as a Result of Cardiorenal Syndrome (CRS) That is Resistant to Optimal Medical Therapy Including Loop Diuretics
- ClinicalTrials.gov ID
- NCT04589065
- Acronym / sponsor ID
- HUM00178335
- Keywords
- Hospitalized
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment on hold pending amendment approval.
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Lenar YessayanUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Oct 2020 (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.
The purpose of this clinical trial is to see if a new device (SCD) is safe and if it can reduce damage to the kidney enough to allow medications to work to improve heart and kidney function for use in patients that have moderate to severe heart failure and is at least in part due to heart failure and it not responding to standard medical therapy. The SCD is a cartridge used with a commercial hemodialysis unit.
Participants will be enrolled in the clinical trial once eligibility is confirmed. In addition to clinical assessments and laboratory testing participants will have surface echocardiograms during the trial. The SCD treatment will take place for 4 hours on day 1, 3, and 5 while on hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selective Cytopheretic Device | Experimental | Device: Selective Cytopheretic Device |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Primary hospitalization for acute decompensated chronic systolic heart failure as defined:
- Baseline Estimated Glomerular Filtration Rate (eGFR)** ≥ 40 ml/min/1.73 m2 (baseline defined as the highest known eGFR within 90 days of study enrollment)
- Worsening renal failure (WRF), defined for the purposes of this study as increase serum creatinine ≥ 0.5 mg/dL from baseline (baseline defined as the lowest known serum creatinine within 90 days of study enrollment)
- Cardiorenal syndrome is the most likely explanation for WRF
- Persistent signs and /or symptoms of congestion (peripheral edema, dyspnea, pulmonary rales, neck vein distension) despite optimal medical therapy including intravenous diuretic therapy and an estimated need for greater than 5 kg. of fluid removal. For the purposes of this study, optimal intravenous diuretic therapy is defined as:
Key exclusion criteria (15 listed)
- Prior sensitivity to dialysis device components
- Individual with known hypersensitivity to citrate
- Bacteremia or possible infection, as evidence by fever, white blood cell count > 10,000/microliter, or any other signs of acute or chronic infection, and any patient receiving antibiotic or antiviral therapy.
- Active malignancy requiring chemotherapy, biological therapy or radiation therapy.
- The use of intravenous iodinated contrast agent within the prior 72 hours or the anticipated use of such an agent during SCD therapy.
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 |
|---|---|---|
| Selective Cytopheretic DeviceSCD therapy will take place for 4 hours on day 1, 3, and 5 while on hemodialysis treatment. Participants will be continue to be followed until 30 days after the last SCD treatment. | Device | Selective Cytopheretic Device |
Primary outcome
Improvement in Cardiac Function - Left Ventricular Ejection Fraction
Time frame: up to 4 weeks following last SCD treatment
This will be assessed by surface echocardiography.
2 secondary outcomes
Improved renal function as measured by serum creatinine
Time frame: up to 4 weeks following the last SCD therapy
Improved renal function as measured by blood urea nitrogen (BUN)
Time frame: up to 4 weeks following the last SCD therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Keith Aaronson, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Cytopheretic Device in people with Heart Failure and Chronic Systolic Heart Failure, run by Lenar Yessayan at 1 site in United States.
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 10 inclusion and 15 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: paused, as of the sponsor's last update on 27 Sep 2024. 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 United States. 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?
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?
Improvement in Cardiac Function - Left Ventricular Ejection Fraction (time frame: up to 4 weeks following last SCD treatment). 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 27 Sep 2024.