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

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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:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date April 12, 2013
First Posted Date August 30, 2013
Results First Submitted Date September 20, 2018
Results First Posted Date December 6, 2018
Last Update Posted Date December 6, 2018
Actual Study Start Date April 2013
Actual Primary Completion Date January 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 8, 2018)
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
Original Primary Outcome Measures
 (submitted: August 27, 2013)
  • Survival rate of participants who did not receive ventricular assist device (VAD) implantation [ Time Frame: Measured through 24 months. ]
    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. ]
    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 ]
    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 ]
    Following 2 baseline visits (3 to 6 weeks apart), participants will be followed at 6 month intervals for 24 months.
Change History
Current Secondary Outcome Measures
 (submitted: November 8, 2018)
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: August 27, 2013)
  • Events [ Time Frame: Measured through 24 months. ]
    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. ]
    Quality of life measures will be collected at baseline and at 6 month intervals for 24 months.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support
Official Title Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
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.
Condition
  • Heart Failure
  • Systolic Heart Failure
Intervention Not Provided
Study Groups/Cohorts MedaMACS participants
All participants who have met the inclusion criteria.
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].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 8, 2018)
171
Original Estimated Enrollment
 (submitted: August 27, 2013)
350
Actual Study Completion Date January 20, 2017
Actual Primary Completion Date January 20, 2017   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01932294
Other Study ID Numbers Medamacs
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
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.
Responsible Party National Heart, Lung, and Blood Institute (NHLBI)
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators Not Provided
Investigators
Principal Investigator: James K Kirklin, MD INTERMACS Principal Investigator
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date January 2017