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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by National Heart, Lung, and Blood Institute (NHLBI)
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT01932294
First received: April 12, 2013
Last updated: March 5, 2014
Last verified: September 2013
  Purpose

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 Intervention
Advanced Heart Failure
Systolic Heart Failure
Other: No Intervention

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Survival rate of participants who did not receive ventricular assist device (VAD) implantation [ Time Frame: Measured through 24 months. ] [ Designated as safety issue: No ]
    Following 2 baseline visits (3 to 6 weeks apart), participants will be followed at 6 month intervals for 24 months.

  • Survival rate of participants who received VAD implantation [ Time Frame: Measured through 24 months. ] [ Designated as safety issue: No ]
    Following 2 baseline visits (3 to 6 weeks apart), participants will be followed at 6 month intervals for 24 months.

  • Survival rate of participants who did not receive heart transplantation [ Time Frame: Measured through 24 months ] [ Designated as safety issue: No ]
    Following 2 baseline visits (3 to 6 weeks apart), participants will be followed at 6 month intervals for 24 months.

  • Survival rate of participants who received heart transplantation [ Time Frame: Measured through 24 months ] [ Designated as safety issue: No ]
    Following 2 baseline visits (3 to 6 weeks apart), participants will be followed at 6 month intervals for 24 months.


Secondary Outcome Measures:
  • Events [ Time Frame: Measured through 24 months. ] [ Designated as safety issue: No ]
    Events (hospitalization, heart transplantation, VAD, death, infection, neurologic, bleeding) will be collected at baseline and at 6 month intervals for 24 months.

  • Quality of Life [ Time Frame: Measured through 24 months. ] [ Designated as safety issue: No ]
    Quality of life measures will be collected at baseline and at 6 month intervals for 24 months.


Estimated Enrollment: 350
Study Start Date: April 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MedaMACS participants
All participants who have met the inclusion criteria.
Other: No Intervention
MedaMACS does not provide intervention or therapy. MedaMACS collects data of routine medical care for patients with advanced heart failure who do not receive a mechanical circulatory support device.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932294

Contacts
Contact: Sharmene Smith 205-975-3906 scsmith4@uab.edu
Contact: Mary Lynne Clark 205-934-2555 mlclark@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: David Baldwin       dbaldwin@uab.edu   
Principal Investigator: Salpy Pamboukian, M.D.         
United States, California
Cedars Sinai Medical Center Recruiting
Beverly Hills, California, United States, 90211
Contact: Maria Thottam       Maria.Thottam@cshs.org   
Principal Investigator: Michelle Kittleson, M.D.         
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Christina Schmitt       Christina.Schmitt@ucdenver.edu   
Principal Investigator: Amrut Ambardekar, M.D.         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Cynthia Larew    319-353-7953    cynthia-larew@uiowa.edu   
Principal Investigator: Linda Cadaret, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Susan Anello    617-732-7174    manello@partners.org   
Principal Investigator: Garrick Stewart, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Joanna Wells    734-232-6383    joannamw@med.umich.edu   
Principal Investigator: Maryse Palardy, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Gayle Challinor    919-668-7184    gayle.challinor@duke.edu   
Principal Investigator: Chetan Patel, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Barbara Gus    216-445-6552    gusb@ccf.org   
Principal Investigator: Maria Mountis, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kimberly Clinton    215-662-2803    kimberly.clinton@uphs.upenn.edu   
Principal Investigator: Eduardo Rame, M.D.         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Traci McGaha    412-647-5724    mcgahat12@upmc.edu   
Principal Investigator: Jeffrey J Teuteberg, MD         
United States, Texas
Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Lynn Fernandez    205-645-8040    lynn.fernandez@utsouthwestern.edu   
Principal Investigator: Jennifer Thebodeau, M.D.         
Sponsors and Collaborators
Investigators
Principal Investigator: James K Kirklin, MD INTERMACS Principal Investigator
  More Information

Additional Information:
Publications:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT01932294     History of Changes
Other Study ID Numbers: MedaMACS
Study First Received: April 12, 2013
Last Updated: March 5, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 16, 2014