Acute Decompensated Heart Failure
Conditions
Keywords
Acute decompensated heart failure, Myocardial blood flow, Coronary flow reserve, Ultrafiltration, Diuretics
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.
Interventions
DRUGLoop diuretics (furosemide, torsemide, bumetanide)
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.
OTHERUltrafiltration
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.
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial Blood Flow | 1 - 5 days | 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). |
Countries
United States
Participant flow
Recruitment details
Patients with acute decompensated heart failure
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants 2 subjects completed the study. 2 subjects did not complete either arm and did not have usable data. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Unable to undergo selected treatment | 1 | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Gender Female | 1 Participants |
| Gender Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
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).
Time frame: 1 - 5 days
Population: No data analyzed due to inadequate enrollment.