Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH)

December 22, 2015 updated by: Columbia University

The REMATCH Trial: Rationale, Design, and End Points. Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure

To conduct a randomized, unblinded clinical trial comparing the left ventricular assist device (LVAD) with maximum medical management in patients with end-stage heart failure who were not candidates for heart transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

Mortality rates for heart failure are high, with five year survival rates approximating 30 to 40 percent in patients with mild to moderate symptoms and 0 to 20 percent survival in patients with severe symptoms. The patient with class IV heart failure has a one year survival rate of only 40 to 50 percent. This is despite advances in medical therapy and the availability of ACE inhibitors. While cardiac transplantation is the most viable form of treatment for these patients, it is limited by complications of chronic immunosuppression, the development of graft coronary artery disease and the serious shortage of donor organs. As many as 16,500 patients per year may be suitable candidates for heart transplantation. The actual number of donor hearts procured over the past few years, however, has remained relatively constant at 2,000. Thus, there is a strong rationale for the therapeutic application of left ventricular assist devices (LVADs) as an alternative to cardiac transplantation.

With respect to LVAD efficacy, patients have been supported for periods as long as 344 days on the pneumatic system and 503 days with the electromechanical device. Experience with the TCI pneumatic system in 75 LVAD patients show improved one year survival after transplantation in the LVAD patients as opposed to patients who did not receive the LVAD despite the same selection criteria. Experience with the vented electric LVADs in bridge patients show a transplant and survival rate that is similar to the pneumatic device. LVADs have also been shown to have a favorable effect on circulatory hemodynamics and exercise capacity. Among 53 patients who survived the TCI LVAD procedure, 90 percent improved to New York Heart Association (NYHA) functional class I and 10 percent to functional class II.

With respect to safety, the principal adverse effects associated with the LVADs include bleeding, hemolysis, and organ dysfunction, thromboembolism, infection, right heart failure, and mechanical failure. Thromboembolic complications are low in the TCI device despite the lack of systemic anticoagulation. The overall mechanical failure rate is small, less than 1 percent in 26 patient years of use. The vented electric and pneumatic device experience to date indicates that the devices are similar with respect to adverse event rates. Thus, in 1997 there was a strong rationale for a randomized controlled trial that compared the benefits and cost of vented electric LVADs to medical treatment. The need to perform a randomized controlled study was further emphasized by the lack of rigorous data on survival, quality of life, and cost effectiveness comparing LVAD support with medical therapy.

DESIGN NARRATIVE:

Unblinded, randomized, multicenter. Patients were randomized to either the Thermo Cardiosystems, Inc. (TCI) vented electric (VE) LVAD or optimal medical therapy (OMM) and followed for at least two years. If randomized to LVAD therapy, patients received a LVAD implantation within 12 hours of randomization. If randomized to medical therapy, patients received optimal medical management including the use of digoxin, diuretics, and ACE (Angiotensin Converting Enzyme) inhibitors in maximally tolerated doses. The primary endpoint was all-cause mortality. Secondary endpoints included cardiovascular mortality, exercise capacity (six-minute walk test) and health-related quality of life, adverse effects, and the relative cost-effectiveness of LVADs versus medical management. Recruitment ended in June, 2001.

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 72 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Men and women with Class III and Class IV congestive heart failure
  2. Between the ages of 18 and 72

Exclusion Criteria

1. Candidates for heart transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Left ventricular assist device
Subjects received Thermo Cardiosystems, Inc. (TCI) vented electric (VE) left ventricular assist device (LVAD) and were followed for at least two years
Device: Left ventricular assist device
A type of implantable heart pump
Other Names:
  • LVAD
ACTIVE_COMPARATOR: Optimal medical therapy
Subjects received optimal medical therapy (OMM) and were followed for at least two years
Device: Optimal medical therapy
(non-experimental) One possibility in handling Heart failure effectively is optimal medicine therapy. The most popular treatment medications at present are ACE Inhibitors and Beta Blockers. The result is the heart being able to pump more effectively and allowing blood to circulate freely.
Other Names:
  • OMM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival rate in LVAD group
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival rate in OMM group
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Eric Rose, MD, Retiree

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1997

Primary Completion (ACTUAL)

March 1, 1999

Study Completion (ACTUAL)

March 1, 1999

Study Registration Dates

First Submitted

October 27, 1999

First Submitted That Met QC Criteria

October 27, 1999

First Posted (ESTIMATE)

October 28, 1999

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2015

Last Update Submitted That Met QC Criteria

December 22, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUMC ID unknown (110)
  • U01HL053986 (NIH)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. NHLBI website

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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