Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support (Medamacs)

• ClinicalTrials.gov Identifier: NCT01932294
• Recruitment Status: Completed
• First Posted: August 30, 2013
• Results First Posted: December 6, 2018
• Last Update Posted: December 6, 2018
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): National Heart, Lung, and Blood Institute (NHLBI)

Study Description

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.

Condition or disease
Heart Failure; Systolic Heart Failure

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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 171 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• Official Title: Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support
• Actual Study Start Date: April 2013
• Actual Primary Completion Date: January 20, 2017
• Actual Study Completion Date: January 20, 2017

Groups and Cohorts

Group/Cohort
MedaMACS participants; All participants who have met the inclusion criteria.

Outcome Measures

Primary Outcome Measures :

1. Number of Heart Failure Participants Deceased at 24 Months [ Time Frame: 6 month intervals after the baseline visit up to 24 months ]
   Death after the baseline visit up to 24 months

Secondary Outcome Measures :

1. Number of Participants With Known Ventricular Assist Device (VAD) Implantation [ Time Frame: 6 month intervals after the baseline visit up to 24 months ]
   Known VAD implantation after the baseline visit up to 24 months
2. Number of Participants With Known Heart Transplantation [ Time Frame: 6 month intervals after the baseline visit up to 24 months ]
   Heart transplantation after the baseline visit up to 24 months

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

United States, California

Cedars Sinai Medical Center

Beverly Hills, California, United States, 90211

United States, Colorado

University of Colorado

Aurora, Colorado, United States, 80045

United States, Iowa

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27710

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

United States, Texas

Southwestern Medical Center

Dallas, Texas, United States, 75390

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: James K Kirklin, MD; INTERMACS Principal Investigator

  Study Documents (Full-Text)

Documents provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Protocol and Statistical Analysis Plan  [PDF] November 16, 2012

More Information

Additional Information:

Click here for more information about this study: MedaMACS 

Publications:

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. Erratum In: J Heart Lung Transplant. 2015 Oct;34(10):1356. Timothy Baldwin, J [corrected to Baldwin, J T].

• Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
• ClinicalTrials.gov Identifier: NCT01932294
• Other Study ID Numbers: Medamacs
• First Posted: August 30, 2013
• Results First Posted: December 6, 2018
• Last Update Posted: December 6, 2018
• Last Verified: January 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data (IPD) is not available. De-identified datasets may be available upon approval.

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Advanced Heart Failure; Refractory Heart Failure; Mechanical Circulatory Support Device; Ventricular Assist Device; Medamacs

Additional relevant MeSH terms:

Heart Failure; Heart Failure, Systolic; Heart Diseases; Cardiovascular Diseases