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Assessment of Coronary Flow Reserve in Heart Failure Patients After Ultrafiltration Versus Diuretics

Primary Purpose

Acute Decompensated Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Loop diuretics (furosemide, torsemide, bumetanide)
Ultrafiltration
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Decompensated Heart Failure focused on measuring Acute decompensated heart failure, Myocardial blood flow, Coronary flow reserve, Ultrafiltration, Diuretics

Eligibility Criteria

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

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Sites / Locations

  • University of Cincinnati/University Hospital
  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultrafiltration

Diuretic Therapy

Arm Description

Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics (loop diuretics: furosemide, bumetanide, and/or torsemide). Patients in this arm are randomized to ultrafiltration.

Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy ((loop diuretics: furosemide, bumetanide, and/or torsemide). The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy with either furosemide, bumetanide, and/or torsemide.

Outcomes

Primary Outcome Measures

Myocardial Blood Flow
Evaluate the effects of ultrafiltration (UF) compared to intravenous diuretic therapy on myocardial blood flow (MBF) and coronary flow reserve (CFR), as assessed by positron emission tomography (PET), in patients with acutely decompensated heart failure (ADHF).

Secondary Outcome Measures

Full Information

First Posted
October 19, 2011
Last Updated
October 24, 2016
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT01457053
Brief Title
Assessment of Coronary Flow Reserve in Heart Failure Patients After Ultrafiltration Versus Diuretics
Official Title
A Randomized Controlled Pilot Study for Assessment of Coronary Flow Reserve With Cardiac PET Imaging in Acute Decompensated Heart Failure Patients Treated With Diuretics Versus Ultrafiltration
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Population not available for enrollment
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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) on your heart function and blood flow.
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 in patients with heart failure is called ultrafiltration. Ultrafiltration may result in more rapid removal of excess fluid and more rapid improvement in your symptoms compared to standard diuretic treatment. Currently, it is unknown what effects these therapies (diuretics or ultrafiltration) have on the small blood vessels in your heart. These small blood vessels are important to supply blood and oxygen to your failing heart. Thus, 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 on your heart function and blood flow.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure
Keywords
Acute decompensated heart failure, Myocardial blood flow, Coronary flow reserve, Ultrafiltration, Diuretics

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrafiltration
Arm Type
Active Comparator
Arm Description
Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics (loop diuretics: furosemide, bumetanide, and/or torsemide). Patients in this arm are randomized to ultrafiltration.
Arm Title
Diuretic Therapy
Arm Type
Active Comparator
Arm Description
Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy ((loop diuretics: furosemide, bumetanide, and/or torsemide). The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy with either furosemide, bumetanide, and/or torsemide.
Intervention Type
Drug
Intervention Name(s)
Loop diuretics (furosemide, torsemide, bumetanide)
Other Intervention Name(s)
Lasix, furosemide, Bumex, bumetanide, Demadex, torsemide
Intervention Description
Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion. Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload. Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety.
Intervention Type
Other
Intervention Name(s)
Ultrafiltration
Other Intervention Name(s)
Aquadex System 100 ultrafiltration device
Intervention Description
Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days. Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety.
Primary Outcome Measure Information:
Title
Myocardial Blood Flow
Description
Evaluate the effects of ultrafiltration (UF) compared to intravenous diuretic therapy on myocardial blood flow (MBF) and coronary flow reserve (CFR), as assessed by positron emission tomography (PET), in patients with acutely decompensated heart failure (ADHF).
Time Frame
1 - 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myron Gerson, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati/University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45221
Country
United States
Facility Name
University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of Coronary Flow Reserve in Heart Failure Patients After Ultrafiltration Versus Diuretics

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