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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)

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Heart Failure
Systolic Heart Failure
Enrollment 171
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MedaMACS Participants
Hide Arm/Group Description All participants who have met the inclusion criteria.
Period Title: Overall Study
Started 171
Completed 72
Not Completed 99
Reason Not Completed
Death             43
Lost to Follow-up             8
VAD Implantation             20
Heart Transplantation             16
Transferred to other hospitals             12
Arm/Group Title MedaMACS Participants
Hide Arm/Group Description All participants who have met the inclusion criteria.
Overall Number of Baseline Participants 171
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants
<=18 years
0
   0.0%
Between 18 and 65 years
53
  31.2%
>=65 years
117
  68.8%
[1]
Measure Analysis Population Description: 1 participant missed this variable
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 171 participants
59.03  (10.95)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants
Female
57
  33.5%
Male
113
  66.5%
[1]
Measure Analysis Population Description: One participant missing a value for the variable
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants
Hispanic or Latino
10
   5.8%
Not Hispanic or Latino
160
  93.6%
Unknown or Not Reported
1
   0.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
47
  27.5%
White
119
  69.6%
More than one race
0
   0.0%
Unknown or Not Reported
5
   2.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 171 participants
171
1.Primary Outcome
Title Number of Heart Failure Participants Deceased at 24 Months
Hide Description Death after the baseline visit up to 24 months
Time Frame 6 month intervals after the baseline visit up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
By the end of the follow-up, 43 patients had deceased.
Arm/Group Title MedaMACS Participants
Hide Arm/Group Description:
All participants who have met the inclusion criteria. By the end of the follow-up, 43 out of 171 patients died.
Overall Number of Participants Analyzed 171
Measure Type: Count of Participants
Unit of Measure: Participants
43
  25.1%
2.Secondary Outcome
Title Number of Participants With Known Ventricular Assist Device (VAD) Implantation
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with known endpoints.
Arm/Group Title MedaMACS Participants
Hide Arm/Group Description:
All participants who have met the inclusion criteria.
Overall Number of Participants Analyzed 171
Measure Type: Count of Participants
Unit of Measure: Participants
20
  11.7%
3.Secondary Outcome
Title Number of Participants With Known Heart Transplantation
Hide Description Heart transplantation after the baseline visit up to 24 months
Time Frame 6 month intervals after the baseline visit up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with known endpoints.
Arm/Group Title MedaMACS Participants
Hide Arm/Group Description:
All participants who have met the inclusion criteria.
Overall Number of Participants Analyzed 171
Measure Type: Count of Participants
Unit of Measure: Participants
16
   9.4%
Time Frame After the baseline visit and up to 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MedaMACS Participants
Hide Arm/Group Description All participants who have met the inclusion criteria.
All-Cause Mortality
MedaMACS Participants
Affected / at Risk (%)
Total   43/171 (25.15%)    
Hide Serious Adverse Events
MedaMACS Participants
Affected / at Risk (%) # Events
Total   93/171 (54.39%)    
Cardiac disorders   
IV Inotropes Dependent at 6 months   12/171 (7.02%) 
Investigations   
Rehospitalization  [1]  93/171 (54.39%)  273
Indicates events were collected by systematic assessment
[1]
All-cause Rehospitalizations
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MedaMACS Participants
Affected / at Risk (%) # Events
Total   12/171 (7.02%)    
Infections and infestations   
All-location Infection  [1]  12/171 (7.02%)  19
Indicates events were collected by systematic assessment
[1]
All-location Infection
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: RongBing Xie
Organization: University of Alabama at Birmingham
Phone: 205-975-3624
EMail: rongbingxie@uabmc.edu
Layout table for additonal information
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT01932294    
Other Study ID Numbers: Medamacs
First Submitted: April 12, 2013
First Posted: August 30, 2013
Results First Submitted: September 20, 2018
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018