Clinical trial NCT01932294: Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support
Official title: Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Systolic Heart Failure
Keywords: Advanced Heart Failure
Refractory Heart Failure
Mechanical Circulatory Support Device
Ventricular Assist Device
Medamacs
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2013-08-30
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be screened for this study if they are between 18 and 80 years old with low ejection fraction history and hospitalization for heart failure within the past year. All subjects who have been admitted to the heart failure service will be screened and recruited for study participation, either as an inpatient or during their first outpatient follow-up appointment by the investigator and research staff caring for patients in the advanced heart failure program of the enrolling center.

Brief summary: Medamacs is a prospective, observational study of ambulatory patients with advanced heart failure. The study enrolls patients who have not yet received a Left Ventricular Assist Device (LVAD) but who receive their care at a hospital with a Joint Commission certified mechanical circulatory support program.

Medamacs is funded through the Interagency for Mechanically Assisted Circulatory Support (INTERMACS) NHLBI Contract.

Detailed description: Participants between 18 and 80 years old with low ejection fraction history and hospitalization for heart failure within the past year will be screened for the study. All subjects who have been admitted to the heart failure service will be screened and recruited, either as an inpatient or during their first outpatient follow-up appointment by the investigator and research staff caring for patients in the advanced heart failure program.

Eligibility for enrollment will be based only upon information that is clinically available at the time of screening. The history of prior hospitalizations will be available from clinical records.

Routine evaluation and triage of ambulatory patients with advanced heart disease includes echocardiography and functional assessment with peak oxygen consumption and frequently 6 minute walk distance. The elements of information required for estimation of the Seattle Heart Failure Risk score will be gleaned from laboratory data, or imputed as described in the Seattle score literature. The research coordinator will enter this data onto a currently available website for calculation of the Seattle score.

Eligibility will be determined by the inclusion and exclusion criteria and the study research team will approach individual subjects who are potential candidates for participation once the subject's primary physician has given permission to approach. Only persons with a scientific or ethical reason will be excluded. Incarcerated prisoners have been excluded by this protocol.

Participants will be followed every 6 months for 24 months after two baseline visits. The 6 month and 18 month follow ups consist of telephone interviews. Follow ups at 12 months and 24 months consists of routine clinical visits.

Approximately 350 patients from 12 centers in the United States will be enrolled over a 12 month period.

Eligibility criteria: INCLUSION CRITERIA:

Patients with Advanced Heart Failure

1. Age 18-80 years
2. New York Heart Association class III-IV heart failure for 45 of the last 60 days
3. Left ventricular ejection fraction ≤ 35%
4. Heart failure diagnosis or typical symptoms for 12 months
5. Use of evidence based oral medications (beta-blockers, ACE-inhibitors/ARBs, aldosterone antagonist) for at least 3 months prior to enrollment or documented medication contraindication or intolerance.
6. Hospitalization for heart failure within the previous 12 months (other than for elective procedure)
7. Informed consent given

In Addition, they must have at least one of the following:

An additional unplanned hospitalization during the previous 12 months for a total of at least 2 inpatient hospitalizations lasting \>24 hours with heart failure as the primary or secondary diagnosis within the previous 12 months

OR

1. Peak oxygen uptake (VO2) \<55% of age- and sex-predicted (using Wasserman equation) OR a peak VO2 ≤16 ml/kg/min for men and ≤14 ml/kg/min for women in a test with an RER \>1.08 on cardiopulmonary exercise testing.
2. 6-minute walk distance \<300 meters without non-cardiac limitation.
3. Serum BNP \> 1000 (NT-proBNP \> 4000 pg/ml) as outpatient or at hospital discharge.

OR

Seattle Heart Failure Model Score \> 1.5.

EXCLUSION CRITERIA:

1. Age \>80 years or \<18 years
2. Non-cardiac diagnosis anticipated to limit 2-year survival (≥30-50% mortality within 2 years from non-cardiac diagnosis)
3. Primary functional limitation from non-cardiac diagnosis even if not likely to limit survival
4. QRS \> 120msec and planned biventricular pacemaker implant or biventricular pacemaker implantation within past 90 days
5. Current home intravenous inotrope therapy
6. Chronic hemodialysis or peritoneal dialysis
7. Scheduled for non-ventricular assist device cardiac surgery on current hospital admission
8. Obvious anatomical or other major contra-indication to any cardiac surgery in the future (e.g. previous pneumonectomy, advanced connective tissue disease)
9. Actively listed for heart transplant as UNOS Status 1 or 2
10. History of cardiac amyloidosis
11. Dominant lesion of at least moderate aortic or mitral stenosis or congenital structural heart defect.

Primary outcomes:
measure: Number of Heart Failure Participants Deceased at 24 Months
timeFrame: 6 month intervals after the baseline visit up to 24 months
Secondary outcomes:
measure: Number of Participants With Known Ventricular Assist Device (VAD) Implantation
timeFrame: 6 month intervals after the baseline visit up to 24 months
measure: Number of Participants With Known Heart Transplantation
timeFrame: 6 month intervals after the baseline visit up to 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Beverly Hills
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: Southwestern Medical Center
state: Texas
Study officials:
affiliation: INTERMACS Principal Investigator
name: James K Kirklin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, Baldwin JT, Young JB. Fifth INTERMACS annual report: risk factor analysis from more than 6,000 mechanical circulatory support patients. J Heart Lung Transplant. 2013 Feb;32(2):141-56. doi: 10.1016/j.healun.2012.12.004.