Status:
TERMINATED
Safety and Efficacy of Direct Blood Volume Measurement in the Treatment of Heart Failure
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Daxor Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
Heart failure is a common cardiac condition affecting nearly 6 million Americans. Silent blood volume overload is common in patients with heart failure and is associated with increased risk of death. ...
Detailed Description
Multicenter prospective randomized trial to compare heart failure management strategies based on clinical assessment of volume status vs. direct measurement of blood volume with a radioisotope techniq...
Eligibility Criteria
Inclusion
- Age \>21 years
- Discharge from hospital or emergency department observation unit with a primary diagnosis of acute decompensated heart failure
- Planned discharge home
- Able and willing to provide informed consent
Exclusion
- Significant co-morbidity during heart failure hospitalization (treated pneumonia, sepsis, respiratory failure, oliguric renal failure, major bleeding requiring transfusion, stroke)
- Heart failure primarily due to significant valvular disease, sub-aortic outflow obstruction, active myocardial ischemia, apical ballooning syndrome, active arrhythmias, active myocarditis, primary restrictive cardiomyopathy, pericardial disease, or congenital heart disease
- Other major co-morbidities that increase mortality risk (stroke with hemiplegia, diabetes with end-organ damage other than heart disease, history of cancer in last 2 years, moderate to severe liver disease, HIV infection with AIDS)
- Hospitalization length of stay \>10 days
- Evidence of acute coronary syndrome during qualifying heart failure hospitalization
- Planned revascularization procedure within 6 months
- Planned implantation of ICD or pacemaker within 6 months
- Planned placement on cardiac transplantation list within 6 months
- Planned other major cardiac surgery or other surgery within 6 months
- Planned intermittent or continuous intravenous positive inotropic therapy
- Planned intermittent or continuous intravenous vasodilator therapy
- Severe obesity (BMI ≥ 40 kg/m2) or cachexia (BMI ≤18 kg/m2)
- Severe chronic kidney disease (estimated GFR\<30 ml/min (Modification of Diet in Renal Disease formula20))
- Hemoglobin \< 10 gm/dl
- Non-cardiac primary limitation to exercise (rheumatological, orthopedic, pulmonary, neurological or peripheral vascular disease)
- Known history of non-adherence with medications
- Psycho-social factors that interfere with ability to adhere to study procedures (dementia, active substance abuse, poorly controlled psychiatric illnesses, inability to travel frequently to the study center)
- Pregnant women or nursing mothers
- Women of childbearing potential not using adequate birth control methods
- Known hypersensitivity to iodine, eggs, or any other component of the Volumex injection kit
- History of anaphylaxis
- Participation in another heart failure investigational treatment protocol currently or \<30 days
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01001312
Start Date
October 1 2010
End Date
June 1 2013
Last Update
October 9 2015
Active Locations (9)
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1
Pacific Cardiology LLC
Honolulu, Hawaii, United States, 96813
2
Rush University Medical Center
Chicago, Illinois, United States
3
Baltimore VA Medical Center
Baltimore, Maryland, United States, 21201
4
Valley Hospital
Ridgewood, New Jersey, United States, 07450