Heart Failure, CongestiveNCT00357591
Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation
A study testing Continuous Aortic Flow Augmentation in people with Heart Failure, Congestive, run by Orqis Medical Corporation at 1 site in United States.
Trial summary
The Company's proprietary products are based on Orqis Medical's hypothesis, supported by early clinical data, that increasing and maintaining continuous blood flow in the descending aorta, known as continuous aortic flow augmentation or CAFA, improves hemodynamics in heart failure patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- Continuous Aortic Flow Augmentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized due to decompensated heart failure who require IV inotropic and/or vasodilator and diuretic therapy
- Patients receiving appropriate medical therapy for heart failure, defined as ACE inhibitors and beta blockers (all unless not tolerated or contraindicated) and diuretics, for 1 month prior to study entry
- For at least 24 hours prior to inclusion into the study, the patient should be treated with a minimum dose of the following: dobutamine 2.5μg/kg/min or milrinone 0.3μg/kg/min or dopamine 5μg/kg/min. or nesiritide 0.01μg/kg/min or nitroglycerin 0.3 µg/kg/min or nitroprusside 0.3 µg/kg/min or a combination of any of these agents, with diuretic therapy. Doses of the above stated medications should be stable for 6 hours prior to inclusion into study. An increase in this dosage within the first 8 hours after enrollment is determined by the attending physician to be unlikely and the following definition of "not responding adequately to IV inotropic and/or vasodilator and diuretic therapy" is exhibited:
- PCWP is ≥ 20 mmHg at time of randomization and PCWP was ≥ 18 mmHg continuously for 24 hours or PCWP ≥ 20 mmHg continuously for 12 hours prior to randomization.
- Cardiac Index < 2.4 L/min/m2
- There is evidence for abnormal renal function and/or diuretic resistance defined as: Serum creatinine > 1.2 mg/dL or Diuretic dosage of intravenous Furosemide ≥ 120 mg daily, or equivalent
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- LVEF < 35%
- Male or female 18-90 years of age
- If female, no child-bearing potential or negative pregnancy test
- Written informed consent
- Willingness to participate in required follow-up exams
Who cannot join
- Acute Q-wave myocardial infarction within past 7 days
- Post cardiotomy shock within past 30 days
- Cardiac surgery within past 14 days
- Bridge to transplant
- History of severe COPD as defined as FEV1 < 1.0 liter
- History of malignant arrhythmias defined as either:
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- sustained ventricular tachycardia > 15 beats or more in length, not associated with a correctable cause, within the preceding 3 months, unless the patient presently has an implantable cardiac defibrillator.
- history of ventricular fibrillation or sudden death, unless the patient presently has an implantable cardiac defibrillator
- Patients implanted with a resynchronization device within the previous 14 days or if there is a possibility of implant within 60 days following randomization
- Systolic pressure <80 mmHg
- Requiring cardiopulmonary support type devices
- Platelets < 50,000/mm3 or other evidence of coagulopathy, INR greater than 1.5 in the absence of anticoagulation therapy.
- Infection (WBC ≥ 12.5 x 103/ml, and or temperature ≥ 100.5°F/38°C)
- History of cerebral vascular accident (CVA) or transient ischemic attacks (TIA) within the last 3 months
- Unwilling or unable to receive blood transfusion
- Inability to undergo treatment with heparin
- Patients on dialysis or serum creatinine > 4.0 mg/dl
- Primary liver disease with bilirubin, SGOT, or SGPT > 4X upper limit of normal
- Life expectancy from other disease < 12 months
- Patients who are active on the cardiac transplantation waiting list, unless there is a documented reason (large body habitus, highly sensitized, O blood group) to anticipate that transplant is unlikely within the subsequent 65 days.
- Symptomatic patent foramen ovale or intracardiac shunt
- Patients diagnosed with clinically significant peripheral vascular disease, defined as absent pedal pulse or signs or symptoms of limb ischemia, including a history of intermittent claudication
- Patients with amyloidosis, thyroid induced heart failure, high output failure secondary to an arterio-venous fistula, and significant uncorrected primary valvular disease (with the exception of mitral regurgitation believed secondary to LV dilatation)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at San Diego
San Diego, California, 92103
About this study
Official title: MOMENTUM: Multicenter Trial of the Orqis Medical CRS for the Enhanced Treatment of CHF Unresponsive to Medical Therapy
The Company's proprietary products are based on Orqis Medical's hypothesis, supported by early clinical data, that increasing and maintaining continuous blood flow in the descending aorta, known as continuous aortic flow augmentation or CAFA, improves hemodynamics in heart failure patients. The clinical impact of the hemodynamic improvement is currently being evaluated to determine the effects of CAFA on stopping or reversing the progression of heart failure through three physiological effects:
- VASCULAR - Reducing systemic vascular resistance
- RENAL - Improving renal function
- CARDIAC - Reducing cardiac workload
- Conditions
- Heart Failure, Congestive
- Being tested
- Continuous Aortic Flow Augmentation
- Keywords
- Heart Failure, Acute Decompensation, Chronic Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Aortic Flow AugmentationDevice
1.0-1.5 lpm augmented blood flow
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Device: Continuous Aortic Flow Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alive, Number of days out of the hospital, not on mechanical assistance over 35 day period.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startSep 2004
- Primary completionJan 2008 (estimated)
- Study completionJan 2008
Why it stopped: Projected neutral significance for primary composite efficacy endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orqis Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Barry H Greenberg, M.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357591
- Sponsor's protocol ID
- IDEG020301
- Status last verified
- Aug 2009
- First submitted
- 25 Jul 2006
- Last updated
- 25 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zile MR, Colombo PC, Mehra M, Greenberg B, Brown S, Konstam MA. Progressive improvement in cardiac performance with continuous aortic flow augmentation (aortic flow therapy) in patients hospitalized with severe heart failure: results of the Multicenter Trial of the Orqis Medical Cancion System for the Enhanced Treatment of Heart Failure Unresponsive to Medical Therapy (MOMENTUM). J Heart Lung Transplant. 2010 Jan;29(1):86-92. doi: 10.1016/j.healun.2009.10.005.
PubMed 20123246Greenberg B, Czerska B, Delgado RM, Bourge R, Zile MR, Silver M, Klapholz M, Haeusslein E, Mehra MR, Mather P, Abraham WT, Neaton JD, Brown BS, Parker IC, Konstam MA; MOMENTUM Investigators and Coordinators. Effects of continuous aortic flow augmentation in patients with exacerbation of heart failure inadequately responsive to medical therapy: results of the Multicenter Trial of the Orqis Medical Cancion System for the Enhanced Treatment of Heart Failure Unresponsive to Medical Therapy (MOMENTUM). Circulation. 2008 Sep 16;118(12):1241-9. doi: 10.1161/CIRCULATIONAHA.108.773275. Epub 2008 Sep 2.
PubMed 18765394
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOMENTUM: Multicenter Trial of the Orqis Medical CRS for the Enhanced Treatment of CHF Unresponsive to Medical Therapy
- ClinicalTrials.gov ID
- NCT00357591
- Acronym / sponsor ID
- IDEG020301
- Conditions
- Heart Failure, Congestive
- Keywords
- Heart Failure, Acute Decompensation, Chronic Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Projected neutral significance for primary composite efficacy endpoint.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Orqis Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Jan 2008 (estimated)
- Study completion
- Jan 2008 (actual)
- First posted
- 27 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Company's proprietary products are based on Orqis Medical's hypothesis, supported by early clinical data, that increasing and maintaining continuous blood flow in the descending aorta, known as continuous aortic flow augmentation or CAFA, improves hemodynamics in heart failure patients. The clinical impact of the hemodynamic improvement is currently being evaluated to determine the effects of CAFA on stopping or reversing the progression of heart failure through three physiological effects:
- VASCULAR - Reducing systemic vascular resistance
- RENAL - Improving renal function
- CARDIAC - Reducing cardiac workload
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Continuous Aortic Flow Augmentation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients hospitalized due to decompensated heart failure who require IV inotropic and/or vasodilator and diuretic therapy
- Patients receiving appropriate medical therapy for heart failure, defined as ACE inhibitors and beta blockers (all unless not tolerated or contraindicated) and diuretics, for 1 month prior to study entry
- For at least 24 hours prior to inclusion into the study, the patient should be treated with a minimum dose of the following: dobutamine 2.5μg/kg/min or milrinone 0.3μg/kg/min or dopamine 5μg/kg/min. or nesiritide 0.01μg/kg/min or nitroglycerin 0.3 µg/kg/min or nitroprusside 0.3 µg/kg/min or a combination of any of these agents, with diuretic therapy. Doses of the above stated medications should be stable for 6 hours prior to inclusion into study. An increase in this dosage within the first 8 hours after enrollment is determined by the attending physician to be unlikely and the following definition of "not responding adequately to IV inotropic and/or vasodilator and diuretic therapy" is exhibited:
- LVEF < 35%
- Male or female 18-90 years of age
Key exclusion criteria (23 listed)
- Acute Q-wave myocardial infarction within past 7 days
- Post cardiotomy shock within past 30 days
- Cardiac surgery within past 14 days
- Bridge to transplant
- History of severe COPD as defined as FEV1 < 1.0 liter
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 |
|---|---|---|
| Continuous Aortic Flow Augmentation1.0-1.5 lpm augmented blood flow | Device | Control |
Primary outcome
Alive, Number of days out of the hospital, not on mechanical assistance over 35 day period.
Time frame: 35 days
Results and safety
The study was stopped early (reason given: Projected neutral significance for primary composite efficacy endpoint.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2009.
- Derived from this study: PubMed 20123246Zile MR, Colombo PC, Mehra M, Greenberg B, Brown S, Konstam MA. Progressive improvement in cardiac performance with continuous aortic flow augmentation (aortic flow therapy) in patients hospitalized with severe heart failure: results of the Multicenter Trial of the Orqis Medical Cancion System for the Enhanced Treatment of Heart Failure Unresponsive to Medical Therapy (MOMENTUM). J Heart Lung Transplant. 2010 Jan;29(1):86-92. doi: 10.1016/j.healun.2009.10.005.
- Derived from this study: PubMed 18765394Greenberg B, Czerska B, Delgado RM, Bourge R, Zile MR, Silver M, Klapholz M, Haeusslein E, Mehra MR, Mather P, Abraham WT, Neaton JD, Brown BS, Parker IC, Konstam MA; MOMENTUM Investigators and Coordinators. Effects of continuous aortic flow augmentation in patients with exacerbation of heart failure inadequately responsive to medical therapy: results of the Multicenter Trial of the Orqis Medical Cancion System for the Enhanced Treatment of Heart Failure Unresponsive to Medical Therapy (MOMENTUM). Circulation. 2008 Sep 16;118(12):1241-9. doi: 10.1161/CIRCULATIONAHA.108.773275. Epub 2008 Sep 2.
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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.
Barry H Greenberg, M.D. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Aortic Flow Augmentation in people with Heart Failure, Congestive, run by Orqis Medical Corporation at 1 site 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 11 inclusion and 23 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 25 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Projected neutral significance for primary composite efficacy endpoint.). Results are not available in the source record.
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?
Alive, Number of days out of the hospital, not on mechanical assistance over 35 day period. (time frame: 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00357591, which also lists 2 linked publications.
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 25 Dec 2009.