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New treatment option for Acute on Chronic Systolic Congestive Heart Failure
Official title Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
ClinicalTrials.gov ID: NCT03836482
What this study is testing
- What it's testing
- Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system but also the renal, neuroendocrine, and immune systems.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age of 18 years and older.
- Evidence of systemic inflammation: blood CRP ≥ 4.5 mg/L or IL-6 ≥ 5.0 pg/ml or neutrophil to lymphocyte ratio ≥3.0.
- Primary hospitalization for acute decompensated chronic systolic heart failure.
- Potential LVAD candidate with: a) Left ventricular ejection fraction ≤25% (for potential destination therapy) or ≤ 35% (for potential bridge to...
- Baseline eGFR\ \ ≥ 40 ml/min/1.73 m2 (baseline defined as the highest known eGFR within 90 days of study enrollment)
You likely can't join if
- Any clear contraindication to LVAD therapy that is unlikely to resolve with improvement in renal function and volume status
- Prior sensitivity to dialysis device components
- Active bacteremia
- Temperature ≥ 101.5 F or WBC ≥ 10,000 K/uL or any patient with suspected systemic infection.
- Metastatic malignancy requiring palliative chemo, biologic, or radiation
- Need for intravenous vasopressor (i.e., phenylephrine, vasopressin), intravenous vasoconstricting inotrope (i.e., norepinephrine or epinephrine) or...
See the full eligibility criteria
- Age of 18 years and older.
- Evidence of systemic inflammation: blood CRP ≥ 4.5 mg/L or IL-6 ≥ 5.0 pg/ml or neutrophil to lymphocyte ratio ≥3.0.
- Primary hospitalization for acute decompensated chronic systolic heart failure.
- Potential LVAD candidate with: a) Left ventricular ejection fraction ≤25% (for potential destination therapy) or ≤ 35% (for potential bridge to transplantation) as confirmed by baseline imaging procedure b) NYHA class...
- Baseline eGFR\ \ ≥ 40 ml/min/1.73 m2 (baseline defined as the highest known eGFR within 90 days of study enrollment)
- At least one of the following two criteria:
- 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...
- 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) AND
- eGFR\ \ ≤ 30 ml/min/1.73 m2 based on serum creatinine at enrollment\ \ \ AND
- Cardiorenal syndrome is the most likely explanation for WRF AND
- Intolerant or inadequately responsive to standard of care diuretic therapy, defined as persistent signs and/or symptoms of congestion (e.g., peripheral edema, dyspnea, pulmonary rales, neck vein distension) or minimal...
- Optimal intravenous diuretic therapy is defined as:
- Furosemide equivalent total daily dose of 240mg
- Furosemide equivalent dose given either as a single or multiple intravenous bolus or continuous infusion
- A furosemide equivalent total daily dose \ 3000 mL urine output/24 hours.
- PA catheter in place at the time of enrollment
- PCW ≥ 20 mmHg
- eGFR calculated using the CKD-EPI Creatinine Equation \ \ \ Recognizing that this is not a steady state creatinine
- Any clear contraindication to LVAD therapy that is unlikely to resolve with improvement in renal function and volume status
- Prior sensitivity to dialysis device components
- Active bacteremia
- Temperature ≥ 101.5 F or WBC ≥ 10,000 K/uL or any patient with suspected systemic infection.
- Metastatic malignancy requiring palliative chemo, biologic, or radiation
- 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...
- Patients requiring mechanical ventilatory support
- Patients requiring total parenteral nutrition during the treatment period
- Persistent SBP \< 80 mmHg
- WBC \< 4000 K/uL
- Platelets \< 100,000K/uL
- Serum creatinine \> 4 mg/dL or receiving dialysis / CRRT
- Acute coronary syndrome within the past month
- Women who are pregnant, breastfeeding a child, or trying to become pregnant
- Concurrent enrollment in another treatment 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
- Use of any other investigational drug or device within the previous 30 days. Patients who participated in a clinical study where only measurements and/or samples are taken (i.e., no test device or drug used) are allowed...
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.