Heart Failure Optimization Study



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:March 1, 2017
End Date:January 2020
Contact:Rachel Jackson
Email:rjackson@zoll.com
Phone:412-968-3333

Use our guide to learn which trials are right for you!

This study is designed as a multi-center prospective observational study of newly diagnosed
Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF)
recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is
achieved. Although the study doesn't start until day 90, all eligible, consenting patients
will be entered into a registry at the start of wearable cardioverter defibrillator (WCD)
use. The pre-study registry will allow us to collect early (90 day) outcomes and data in
those patients who are likely to be eligible for the study at day 90, or are eligible, but
refuse the study at day 90.

This study will be conducted at thirty to sixty sites, initially in US and Europe. It will be
used to observe the rate of recovery of ventricular function (EF>35%) between 90 and 180 days
in newly diagnosed HF patients who were prescribed the WCD ≤ 10 days post-discharge after
hospitalization for a primary reason of new onset HF (≤30 days since first HF
hospitalization), with ischemic or non-ischemic cardiomyopathy, and have already used a WCD
for 90 ± 14 days. For the first 90 days of WCD use, patients will be enrolled in a pre-study
registry. The FDA-approved WCD will be prescribed for up to 6 months of use after hospital
discharge, with the option for longer use under physician discretion. Approximately 870
subjects will enroll into the pre-study registry and 750 subjects into the study.

Inclusion Criteria:

Part 1

- Patients (≥18 years old) who were prescribed the WCD ≤ 10 days post-discharge after
hospitalization for a primary reason of new onset HF (≤30 days since first HF
hospitalization), with ischemic or nonischemic cardiomyopathy, and have used the WCD
for no more than 30 days.

- Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if
performed multiple times).

Part 2

- Patients (≥18 years old) who were prescribed the WCD ≤ 10 days post-discharge after
hospitalization for a primary reason of new onset HF (≤30 days since first HF
hospitalization), with ischemic or nonischemic cardiomyopathy, and have already used a
WCD for 90 ± 14 days.

- Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if
performed multiple times). Of note, EF at 90 ± 14 days post-hospitalization does not
need to be low to be included in the study.

Exclusion Criteria:

- Patients under 18 years old.

- Patients who have an active unipolar pacemaker.

- Patients with a physical or mental condition that could impair their ability to
properly interact with the device.

- Patients currently participating in another clinical study.

- Patients with any skin condition that would prevent wearing the device.

- Patients with an advanced directive prohibiting resuscitation.

- Patients who are indicated for cardiac resynchronization therapy or have a QRS
duration of ≥135 ms.

- Patients with recent myocardial infarction or coronary revascularization (since start
of WCD wear; i.e. 0-90 days of WCD wear).
We found this trial at
37
sites
Barberton, Ohio 44203
?
mi
from
Barberton, OH
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Aurora, IL
Click here to add this to my saved trials
Birmingham, Alabama 35294
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
3435 Bailey Avenue
Buffalo, New York 14215
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
CHapel Hill, North Carolina 27599
?
mi
from
CHapel Hill, NC
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
1348 South 18th Street
Fernandina Beach, Florida 32034
?
mi
from
Fernandina Beach, FL
Click here to add this to my saved trials
30 Prospect Avenue
Hackensack, New Jersey 07601
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
17800 Kedzie Avenue
Hazel Crest, Illinois 60429
?
mi
from
Hazel Crest, IL
Click here to add this to my saved trials
Huntington, West Virginia 25702
?
mi
from
Huntington, WV
Click here to add this to my saved trials
Jackson, Mississippi 39216
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Jacksonville, Florida 32207
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jacksonville Beach, Florida 32250
?
mi
from
Jacksonville Beach, FL
Click here to add this to my saved trials
4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
1029 West Meeting Street
Lancaster, South Carolina 29720
?
mi
from
Lancaster, SC
Click here to add this to my saved trials
?
mi
from
Linz,
Click here to add this to my saved trials
4820 West Taft Road
Liverpool, New York 13088
?
mi
from
Liverpool, NY
Click here to add this to my saved trials
1265 Union Avenue
Memphis, Tennessee 38104
?
mi
from
Memphis, TN
Click here to add this to my saved trials
1300 Wesley Drive
Memphis, Tennessee 38116
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Munster, IN
Click here to add this to my saved trials
479 Oxford
New Braunfels, Texas 78130
?
mi
from
New Braunfels, TX
Click here to add this to my saved trials
80 Vermont Avenue
Oak Ridge, Tennessee 37830
?
mi
from
Oak Ridge, TN
Click here to add this to my saved trials
?
mi
from
Ocala, FL
Click here to add this to my saved trials
Orlando, Florida 32825
?
mi
from
Orlando, FL
Click here to add this to my saved trials
815 Main Street
Peoria, Illinois 61602
?
mi
from
Peoria, IL
Click here to add this to my saved trials
3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pomona, New Jersey 08240
?
mi
from
Pomona, NJ
Click here to add this to my saved trials
Saint Louis, Missouri 63136
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Sayre, Pennsylvania 18840
?
mi
from
Sayre, PA
Click here to add this to my saved trials
Sioux Falls, South Dakota 57104
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
South Bend, Indiana 46601
?
mi
from
South Bend, IN
Click here to add this to my saved trials
Voorhees, New Jersey 08043
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
Waco, Texas 76712
?
mi
from
Waco, TX
Click here to add this to my saved trials
?
mi
from
West Hills, CA
Click here to add this to my saved trials