Heart FailureMedamacsNCT01932294
Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support
An observational study of Heart Failure and Systolic Heart Failure, run by National Heart, Lung, and Blood Institute (NHLBI) at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Systolic Heart Failure
- How many people
- 171 participants
- Where
- 11 sitesUnited States
- Study dates
- Apr 2013to 20 Jan 2017
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with Advanced Heart Failure
- Age 18-80 years
- New York Heart Association class III-IV heart failure for 45 of the last 60 days
- Left ventricular ejection fraction ≤ 35%
- Heart failure diagnosis or typical symptoms for 12 months
- 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.
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- Hospitalization for heart failure within the previous 12 months (other than for elective procedure)
- 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
- 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.
- 6-minute walk distance <300 meters without non-cardiac limitation.
- Serum BNP > 1000 (NT-proBNP > 4000 pg/ml) as outpatient or at hospital discharge.
- OR
- Seattle Heart Failure Model Score > 1.5.
Who cannot join
- Age >80 years or <18 years
- Non-cardiac diagnosis anticipated to limit 2-year survival (≥30-50% mortality within 2 years from non-cardiac diagnosis)
- Primary functional limitation from non-cardiac diagnosis even if not likely to limit survival
- QRS > 120msec and planned biventricular pacemaker implant or biventricular pacemaker implantation within past 90 days
- Current home intravenous inotrope therapy
- Chronic hemodialysis or peritoneal dialysis
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- Scheduled for non-ventricular assist device cardiac surgery on current hospital admission
- Obvious anatomical or other major contra-indication to any cardiac surgery in the future (e.g. previous pneumonectomy, advanced connective tissue disease)
- Actively listed for heart transplant as UNOS Status 1 or 2
- History of cardiac amyloidosis
- Dominant lesion of at least moderate aortic or mitral stenosis or congenital structural heart defect.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
Cedars Sinai Medical Center
Beverly Hills, California, 90211
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Southwestern Medical Center
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27710
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Heart Failure, Systolic Heart Failure
- Keywords
- Advanced Heart Failure, Refractory Heart Failure, Mechanical Circulatory Support Device, Ventricular Assist Device, Medamacs
- Medical subject headings
- Heart Failure, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MedaMACS participants | All participants who have met the inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Heart Failure Participants Deceased at 24 Months
Death after the baseline visit up to 24 months
Measured: 6 month intervals after the baseline visit up to 24 months
Secondary outcomes (2)
Number of Participants With Known Ventricular Assist Device (VAD) Implantation
Known VAD implantation after the baseline visit up to 24 months
Measured: 6 month intervals after the baseline visit up to 24 months
Number of Participants With Known Heart Transplantation
Heart transplantation after the baseline visit up to 24 months
Measured: 6 month intervals after the baseline visit up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startApr 2013
- Primary completion20 Jan 2017
- Study completion20 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- James K Kirklin, MD, Principal investigator, INTERMACS Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932294
- Sponsor's protocol ID
- Medamacs
- Acronym
- Medamacs
- Status last verified
- Jan 2017
- First submitted
- 12 Apr 2013
- Last updated
- 6 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Individual participant data (IPD) is not available. De-identified datasets may be available upon approval.
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.
PubMed 23352390
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support
- ClinicalTrials.gov ID
- NCT01932294
- Acronym / sponsor ID
- Medamacs / Medamacs
- Conditions
- Heart Failure, Systolic Heart Failure
- Keywords
- Advanced Heart Failure, Refractory Heart Failure, Mechanical Circulatory Support Device, Ventricular Assist Device, Medamacs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 2013 (actual)
- Primary completion
- 20 Jan 2017 (actual)
- Study completion
- 20 Jan 2017 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Posted 6 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MedaMACS participants | – | –All participants who have met the inclusion criteria. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- Patients with Advanced Heart Failure
- Age 18-80 years
- New York Heart Association class III-IV heart failure for 45 of the last 60 days
- Left ventricular ejection fraction ≤ 35%
- Heart failure diagnosis or typical symptoms for 12 months
Key exclusion criteria (11 listed)
- Age >80 years or <18 years
- Non-cardiac diagnosis anticipated to limit 2-year survival (≥30-50% mortality within 2 years from non-cardiac diagnosis)
- Primary functional limitation from non-cardiac diagnosis even if not likely to limit survival
- QRS > 120msec and planned biventricular pacemaker implant or biventricular pacemaker implantation within past 90 days
- Current home intravenous inotrope therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Number of Participants With Known Ventricular Assist Device (VAD) Implantation
Time frame: 6 month intervals 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23352390Kirklin 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) is not available. De-identified datasets may be available upon approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James K Kirklin, MD principal investigator
INTERMACS Principal Investigator
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Systolic Heart Failure, run by National Heart, Lung, and Blood Institute (NHLBI) at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Heart Failure Participants Deceased at 24 Months (time frame: 6 month intervals after the baseline visit up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01932294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.