Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support

Heart Failure Clinical Trial

— Medamacs  

Official title:

Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932294
• Other study ID #: Medamacs
• Status: Completed
• Start date: April 2013
• Est. completion date: January 20, 2017

Study information

• Verified date: January 2017
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Medamacs is funded through the Interagency for Mechanically Assisted Circulatory Support (INTERMACS) NHLBI Contract.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: January 20, 2017
• Est. primary completion date: January 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Systolic Heart Failure

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	Cedars Sinai Medical Center	Beverly Hills	California
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Southwestern Medical Center	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Heart Failure Participants Deceased at 24 Months	Death after the baseline visit up to 24 months	6 month intervals after the baseline visit up to 24 months
Secondary	Number of Participants With Known Ventricular Assist Device (VAD) Implantation	Known VAD implantation after the baseline visit up to 24 months	6 month intervals after the baseline visit up to 24 months
Secondary	Number of Participants With Known Heart Transplantation	Heart transplantation after the baseline visit up to 24 months	6 month intervals after the baseline visit up to 24 months

External Links

•   Click here for more information about this study: MedaMACS