Selective Cytopheretic Device for Cardio-Renal Syndrome

1
Effectiveness
1
Safety
University of Michigan, Ann Arbor, MI
Cardio-Renal Syndrome+5 More
Selective Cytopheretic Device - Device
Eligibility
18+
All Sexes
Eligible conditions
Cardio-Renal Syndrome

Study Summary

Selective Cytopheretic Device (SCD) Trial

See full description

Eligible Conditions

  • Cardio-Renal Syndrome
  • Syndrome
  • Systolic Murmurs
  • Heart Failure
  • Acute on Chronic Systolic Congestive Heart Failure
  • Cardiorenal Syndrome (CRS)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Selective Cytopheretic Device will improve 1 primary outcome and 15 secondary outcomes in patients with Cardio-Renal Syndrome. Measurement will happen over the course of up to 30 days after the last SCD.

Day 30
Percentage of subjects receiving a left ventricular assist device with serum creatinine ≥ 0.5 mg/dL below level at study entry
Day 6
Change in 24 hour urine volume
Change in Pulmonary Capillary Wedge Pressure (PCWP)
Change in blood urea nitrogen (BUN)
Change in creatinine clearance
Change in serum creatinine
Change in serum dissolved carbon dioxide (CO2)
Change in serum potassium
Change in serum sodium
Change in urine creatinine
Change in urine sodium
Change in urine urea
Change in urine urea clearance
Percentage of subjects with reduction of serum creatinine (≥ 0.5 mg/dL) and PCWP (≤ 18 mmHg)
Day 30
Percentage of subject receiving a left ventricular assist device
Day 30
Percent of patients with reversal of Worsening Renal Function (WRF)

Trial Safety

Trial Design

2 Treatment Groups

Control
Selective Cytopheretic Device

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. Selective Cytopheretic Device is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Selective Cytopheretic Device
Device
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from onset of intervention to 3 and 6 days after initiation of scd treatments and from onset of intervention to end of scd support prior to lvad implantation
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from onset of intervention to 3 and 6 days after initiation of scd treatments and from onset of intervention to end of scd support prior to lvad implantation for reporting.

Closest Location

University of Michigan - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Left ventricular ejection fraction ≤25% (for potential destination therapy) or ≤ 35% (for potential bridge to transplantation) as confirmed by baseline imaging procedure
Primary hospitalization for acute decompensated chronic systolic heart failure
NYHA class IIIB or IV chronic (≤ 90 days) systolic heart failure, with failure to respond to optimal medical therapy (beta blocker, ACE inhibitor or ARB or valsartan/sacubitril, aldosterone antagonist, unless not tolerated or contraindicated, and loop diuretic, as needed) for 45 of the last 60 days
Known previous peak exercise oxygen consumption < 14 mL/Kg/min or if unable to exercise, dependent on an intra-aortic balloon pump, short-term mechanical circulatory support device or intravenous inotropes unless inotropes contraindicated for clinical reasons (e.g., ventricular arrhythmias)
Baseline eGFR** ≥ 40 ml/min/1.73 m2 (baseline defined as the highest known eGFR within 90 days of study enrollment)
Severe right ventricular failure (RVF), defined as meeting at least 2 of the following 4 criteria
Central venous pressure > 16 mmHg
Central venous pressure/Pulmonary wedge pressure >0.65
Right ventricular stroke work index < 300 mmHg * ml/m2
Pulmonary artery pulsatility index (PAPi) < 2

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is cardio-renal syndrome?

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Cardio-renal syndrome is the term given to the combination of cardiovascular and renal pathology, which is the interaction of cardiac and renal dysfunction occurring simultaneously and in a similar fashion. The name of the syndrome was first suggested by Sir Arthur R. Evans in 1964.\n\nThe syndrome's causes were unknown until the end of the 19th Century and has since been thought to have multiple etiologies.\n\nThis disease is not yet completely known which explains the wide range of treatments used.\n\nThere are several important treatments in regards to cardiac and renal surgery that can be used with cardiac transplants.

Unverified Answer

What are the signs of cardio-renal syndrome?

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Some signs and symptoms of the syndrome include excessive thirst, and excessive urination. There is little consensus among healthcare providers regarding optimal intervention. Some clinicians treat patients with ACE inhibitors with the goal of reducing symptoms. However, there is evidence both for and against use of ACE inhibitors for congestive heart failure.

Unverified Answer

What are common treatments for cardio-renal syndrome?

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The data presented in this review demonstrate that patients with cardio-renal syndrome frequently do not receive appropriate pharmacological and medical treatment for their medical conditions.

Unverified Answer

Can cardio-renal syndrome be cured?

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Despite the limited experience, these preliminary results suggest that patients who present with mild forms of CRS are at risk of poor outcome. More patients with CRS in this series underwent curative therapy than previously reported. These data have shown that patients with mild forms of CRS have a high risk of poor survival.

Unverified Answer

How many people get cardio-renal syndrome a year in the United States?

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About 12% of people with suspected cardiomyopathy in this study are found to have cardiac dysfunction and a diagnosis of CKD based on SCr level. Further study is needed to elucidate the link between cardiac disease and CKD and its risk of cardiovascular mortality.

Unverified Answer

What causes cardio-renal syndrome?

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It is clear that a combination of cardiovascular disease and nephrotic syndrome result in cardiac arrest and renal failure. The pathophysiology of this combined syndrome remains unclear. However, one theory suggests that the pathogenesis of renal failure due to nephrotic syndrome and cardiovascular disease may be similar. If true, renal failure is likely to appear during cardiovascular disease. However, if this is the case, the pathogenesis of acute kidney injury resulting from cardiovascular disease may be identical when nephrotic syndrome is present. However, further data and experiments will be needed to determine whether nephrotic syndrome and cardiovascular disease are similar entities or two distinct entities.

Unverified Answer

Is selective cytopheretic device safe for people?

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Until a randomized controlled trial is done to assess if selective cytopheretic devices will improve long-term survival in this population and to evaluate short-term and long-term outcomes compared to standard hemodialysis therapy we cannot recommend selective cytopheretic devices.

Unverified Answer

What is the primary cause of cardio-renal syndrome?

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This case would lend credence to a hypothesis that chronic venous congestion may be an important cause of cardio-renal syndrome. This is one reason why patients with significant chronic venous hypertension should be encouraged to initiate an anti-coagulant regimen in an attempt to reduce venous hyper-vigilance and thereby ameliorate or eliminate the syndrome.

Unverified Answer

Does selective cytopheretic device improve quality of life for those with cardio-renal syndrome?

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A cytopheretic device is able to decrease the volume of fluid output and is well tolerated in this population. However, it was not an independent predictor of HRQoL-assessed quality-of-life. When comparing HRQoL and volume of fluid output in this population, other treatment modalities may be required for the management of heart failure and renal failure.

Unverified Answer

What is the latest research for cardio-renal syndrome?

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[The majority of current information about CRS is based on very brief presentations on clinical guidelines. As a consequence there is an urgent need for guidelines to be derived from large, high quality clinical trials that include more than a hundred patients, and ideally long-term follow-up data in order to estimate how long patients need to continue taking their drugs. This is urgently missing in patients with CRS who have undergone several investigations but not had long-term outcome data collected to help manage drug use, prognosis, and lifestyle factors.

Unverified Answer

What is selective cytopheretic device?

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S.C.D.s may have advantages when used for selective filtration of large blood volumes. However, larger studies are required to further evaluate the role of S.C.D. in routine clinical practice.

Unverified Answer

What does selective cytopheretic device usually treat?

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Our patients had significant heart disease and/or kidney disease, probably due to the long time of anorexia and/or refeeding which was not followed by the regular medical follow ups. This resulted in the rapid deterioration of their health condition and may explain why we did not achieve the good results in treating this disease.

Unverified Answer
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