Safety and Efficacy of Direct Blood Volume Measurement in the Treatment of Heart Failure

Heart Failure Clinical Trial

— TEAM-HF  

Official title:

Treating to Euvolemia by Clinical Assessment and Measured Blood Volume in Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01001312
• Other study ID #: H09-560
• Status: Terminated
• Phase: Phase 4
• First received: October 22, 2009
• Last updated: October 8, 2015
• Start date: October 2010
• Est. completion date: June 2013

Study information

• Verified date: October 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. This study is designed to determine if adjustment of therapy based on direct measurement of blood volume will reduce risk of hospitalization and death when compared with therapy based on clinical assessment of blood volume in patients with chronic heart failure.

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 technique. Subjects will be randomly assigned to a standard care strategy with guideline recommended treatment based on serial clinical assessment of blood volume or a measured blood volume strategy with guideline recommended treatment based on serial measured blood volume. All subjects will undergo blood volume measurement procedures, but the testing results will only be returned to the physician in the group assigned to management according to measured blood volume status. Subjects will be blinded to their study treatment assignment status.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Daxor Blood Volume Analysis
Radiolabeled albumin for direct measurement of blood volume
• Clinical volume status assessment
Volume assessment based on history and physical examination

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center	Baltimore	Maryland
United States	St. Luke's Regional Heart Center-Bethlehem	Bethlehem	Pennsylvania
United States	Rush University Medical Center	Chicago	Illinois
United States	Pacific Cardiology LLC	Honolulu	Hawaii
United States	St. Thomas Research Institute	Nashvilled	Tennessee
United States	Columbia Presbyterian Medical Center	New York	New York
United States	New York University Langone Medical Center	New York	New York
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Valley Hospital	Ridgewood	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Daxor Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization-free Survival		6 months	Yes
Secondary	Cardiovascular mortality		6 months	Yes
Secondary	Heart failure hospitalization		6 months	Yes
Secondary	Quality of life questionnaire (KCCQ)		6 months	No
Secondary	6 minute walk test		6 months	No
Secondary	Hospitalization for worsening renal function		6 months	Yes
Secondary	All cause hospitalization		6 months	Yes
Secondary	All cause mortality		6 months	Yes