Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support

NCT ID: NCT01932294

Last Updated: 2018-12-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 171 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-01-20

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.

Conditions

Heart Failure; Systolic Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MedaMACS participants

All participants who have met the inclusion criteria.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James K Kirklin, MD

Role: PRINCIPAL_INVESTIGATOR

INTERMACS Principal Investigator

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Cedars Sinai Medical Center

Beverly Hills, California, United States

University of Colorado

Aurora, Colorado, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Duke University

Durham, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23352390 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.intermacs.org

Click here for more information about this study: MedaMACS

Other Identifiers

Medamacs

Identifier Type: -

Identifier Source: org_study_id