Status:
TERMINATED
Assessment of Coronary Flow Reserve in Heart Failure Patients After Ultrafiltration Versus Diuretics
Lead Sponsor:
University of Cincinnati
Conditions:
Acute Decompensated Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this research study is to compare the effects (good and bad) of ultrafiltration treatment with standard intravenous (in your vein) diuretic therapy (furosemide, torsemide, bumetanide) o...
Detailed Description
The standard of care to treat congestive heart failure is with a class of medication called diuretics, which remove the extra fluid from the body through urination. Another way to remove extra fluid i...
Eligibility Criteria
Inclusion
- males and non-pregnant female patients over 18 years admitted to the hospital or treated in an outpatient heart failure clinic with the primary diagnosis of acute decompensated heart failure.
- evidence of fluid overload more than 8 kg above their dry weight, and conforming to definition of hypervolemia (at least two of the following findings: more than 1+ pitting edema of the lower extremities, jugular venous pressure more than 10 cm water, pulmonary edema or pleural effusion on chest radiograph consistent with ADHF, ascites, paroxysmal nocturnal dyspnea, or equal or more than 2 pillow orthopnea.
Exclusion
- acute coronary syndrome
- documented ischemic cardiomyopathy
- atrial fibrillation
- serum creatinine more than 3.0 mg/dL
- systolic blood pressure less than 90 mmHg
- hematocrit \> 45%
- clinical instability likely to require intravenous vasopressors and/or intravenous vasoactive drugs (such as milrinone, dobutamine, nitroglycerin or nesiritide) during the present hospitalization
- severe pulmonary hypertension or use of pulmonary hypertension drugs (such as sildenafil, bosentan or other endothelin inhibitors)
- patients with documented hypertrophic obstructive cardiomyopathy or restrictive cardiomyopathy,
- patients with severe valvular heart disease,
- patients with recent cocaine use (within one month of presentation)
- patients with heart transplant
- patients with systemic infection
- patients on hemodialysis
- inability to obtain venous access
- contraindications for anticoagulation
- unable to lie flat for at least 20 minutes
- pregnant and breast-feeding women.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01457053
Start Date
November 1 2011
End Date
May 1 2013
Last Update
December 5 2016
Active Locations (2)
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1
University of Cincinnati/University Hospital
Cincinnati, Ohio, United States, 45221
2
University Hospital
Cincinnati, Ohio, United States, 45267