Acute Decompensated Heart FailureNCT01457053
Assessment of Coronary Flow Reserve in Heart Failure Patients After Ultrafiltration Versus Diuretics
A study testing Loop diuretics (furosemide, torsemide, bumetanide) and Ultrafiltration in people with Acute Decompensated Heart Failure, run by University of Cincinnati at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- Loop diuretics (furosemide, torsemide, bumetanide) and Ultrafiltration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%
Show all 18Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Cincinnati/University Hospital
Cincinnati, Ohio, 45221
University Hospital
Cincinnati, Ohio, 45267
About this study
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
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.
Read the 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.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- Loop diuretics (furosemide, torsemide, bumetanide), Ultrafiltration
- Keywords
- Acute decompensated heart failure, Myocardial blood flow, Coronary flow reserve, Ultrafiltration, Diuretics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loop diuretics (furosemide, torsemide, bumetanide)Drug
Also called Lasix, furosemide, Bumex, bumetanide, Demadex, torsemide
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.
UltrafiltrationOther
Also called Aquadex System 100 ultrafiltration device
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrafiltration | Active comparator | 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. Receives: Other: Ultrafiltration |
| Diuretic Therapy | Active comparator | 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. Receives: Drug: Loop diuretics (furosemide, torsemide, bumetanide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 - 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: Population not available for enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myron C. Gerson, University of Cincinnati
- Investigators
- Myron Gerson, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457053
- Sponsor's protocol ID
- 11051904
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2011
- Last updated
- 5 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01457053
- Acronym / sponsor ID
- 11051904
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Acute decompensated heart failure, Myocardial blood flow, Coronary flow reserve, Ultrafiltration, Diuretics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Population not available for enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Oct 2011 (estimated)
- Results
- Posted 8 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrafiltration | Active comparator | Other: UltrafiltrationPatients 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. |
| Diuretic Therapy | Active comparator | Drug: Loop diuretics (furosemide, torsemide, bumetanide)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (18 listed)
- acute coronary syndrome
- documented ischemic cardiomyopathy
- atrial fibrillation
- serum creatinine more than 3.0 mg/dL
- systolic blood pressure less than 90 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loop diuretics (furosemide, torsemide, bumetanide)Also: Lasix, furosemide, Bumex, bumetanide, Demadex, torsemidePatients 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. | Drug | Diuretic Therapy |
| UltrafiltrationAlso: Aquadex System 100 ultrafiltration deviceSubjects 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. | Other | Ultrafiltration |
Primary outcome
Myocardial Blood Flow
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myron Gerson, MD principal investigator
University of Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loop diuretics (furosemide, torsemide, bumetanide) and Ultrafiltration in people with Acute Decompensated Heart Failure, run by University of Cincinnati at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial Blood Flow (time frame: 1 - 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.