Heart Failure, Systolic Heart Failure
Conditions
Keywords
Advanced Heart Failure, Refractory Heart Failure, Mechanical Circulatory Support Device, Ventricular Assist Device, Medamacs
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.
Interventions
None listed
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MedaMACS Participants All participants who have met the inclusion criteria. | 171 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 43 |
| Overall Study | Heart Transplantation | 16 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Transferred to other hospitals | 12 |
| Overall Study | VAD Implantation | 20 |
Baseline characteristics
| Characteristic | MedaMACS Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 117 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants |
| Age, Continuous | 59.03 years STANDARD_DEVIATION 10.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 160 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 119 Participants |
| Region of Enrollment United States | 171 participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 43 / 171 |
| other Total, other adverse events | 12 / 171 |
| serious Total, serious adverse events | 93 / 171 |
Outcome results
Primary
Number of Heart Failure Participants Deceased at 24 Months
Death after the baseline visit up to 24 months
Time frame: 6 month intervals after the baseline visit up to 24 months
Population: By the end of the follow-up, 43 patients had deceased.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MedaMACS Participants | Number of Heart Failure Participants Deceased at 24 Months | 43 Participants |
Secondary
Number of Participants With Known Heart Transplantation
Heart transplantation after the baseline visit up to 24 months
Time frame: 6 month intervals after the baseline visit up to 24 months
Population: Patients with known endpoints.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MedaMACS Participants | Number of Participants With Known Heart Transplantation | 16 Participants |
Secondary
Number of Participants With Known Ventricular Assist Device (VAD) Implantation
Known VAD implantation after the baseline visit up to 24 months
Time frame: 6 month intervals after the baseline visit up to 24 months
Population: Patients with known endpoints.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MedaMACS Participants | Number of Participants With Known Ventricular Assist Device (VAD) Implantation | 20 Participants |