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

• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT01932294
• Collaborator: (none)
• Enrollment: 171
• Locations: 11
• Actual Duration (Months): 45.7
• Patients Per Site: 15.5
• Patients Per Site Per Month: 0.3

Study Details

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	Intervention/Treatment	Phase
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
• Official Title: Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support
• Actual Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jan 20, 2017
• Actual Study Completion Date: Jan 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
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 [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 [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 [6 month intervals after the baseline visit up to 24 months]

   Heart transplantation after the baseline visit up to 24 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. 6-minute walk distance <300 meters without non-cardiac limitation.

2. 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

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Cedars Sinai Medical Center	Beverly Hills	California	United States	90211
3	University of Colorado	Aurora	Colorado	United States	80045
4	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
5	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
6	University of Michigan	Ann Arbor	Michigan	United States	48109
7	Duke University	Durham	North Carolina	United States	27710
8	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
9	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
10	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
11	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)

• Study Protocol and Statistical Analysis Plan - Nov 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: Aug 30, 2013
• Last Update Posted: Dec 6, 2018
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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

Study Results

Participant Flow

Arm/Group Title	MedaMACS Participants
Arm/Group Description	All participants who have met the inclusion criteria.
Period Title: Overall Study
STARTED	171
COMPLETED	72
NOT COMPLETED	99

Baseline Characteristics

Arm/Group Title	MedaMACS Participants
Arm/Group Description	All participants who have met the inclusion criteria.
Overall Participants	171
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	53 31%
>=65 years	117 68.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.03 (10.95)
Sex: Female, Male (Count of Participants)
Female	57 33.3%
Male	113 66.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 5.8%
Not Hispanic or Latino	160 93.6%
Unknown or Not Reported	1 0.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	47 27.5%
White	119 69.6%
More than one race	0 0%
Unknown or Not Reported	5 2.9%
Region of Enrollment (participants) [Number]
United States	171 100%

Outcome Measures

1. Primary Outcome

Title	Number of Heart Failure Participants Deceased at 24 Months
Description	Death after the baseline visit up to 24 months
Time Frame	6 month intervals after the baseline visit up to 24 months

Outcome Measure Data

Analysis Population Description

By the end of the follow-up, 43 patients had deceased.

Arm/Group Title	MedaMACS Participants
Arm/Group Description	All participants who have met the inclusion criteria. By the end of the follow-up, 43 out of 171 patients died.
Measure Participants	171
Count of Participants [Participants]	43 25.1%

2. Secondary Outcome

Title	Number of Participants With Known Ventricular Assist Device (VAD) Implantation
Description	Known VAD implantation after the baseline visit up to 24 months
Time Frame	6 month intervals after the baseline visit up to 24 months

Outcome Measure Data

Analysis Population Description

Patients with known endpoints.

Arm/Group Title	MedaMACS Participants
Arm/Group Description	All participants who have met the inclusion criteria.
Measure Participants	171
Count of Participants [Participants]	20 11.7%

3. Secondary Outcome

Title	Number of Participants With Known Heart Transplantation
Description	Heart transplantation after the baseline visit up to 24 months
Time Frame	6 month intervals after the baseline visit up to 24 months

Outcome Measure Data

Analysis Population Description

Patients with known endpoints.

Arm/Group Title	MedaMACS Participants
Arm/Group Description	All participants who have met the inclusion criteria.
Measure Participants	171
Count of Participants [Participants]	16 9.4%

Adverse Events

Time Frame	After the baseline visit and up to 24 months
Arm/Group Title	MedaMACS Participants
Arm/Group Description	All participants who have met the inclusion criteria.
All Cause Mortality
	MedaMACS Participants
	Affected / at Risk (%)	# Events
Total	43/171 (25.1%)
Serious Adverse Events
	MedaMACS Participants
	Affected / at Risk (%)	# Events
Total	93/171 (54.4%)
Cardiac disorders
IV Inotropes Dependent at 6 months	12/171 (7%)
Investigations
Rehospitalization	93/171 (54.4%)	273
Other (Not Including Serious) Adverse Events
	MedaMACS Participants
	Affected / at Risk (%)	# Events
Total	12/171 (7%)
Infections and infestations
All-location Infection	12/171 (7%)	19

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.