A Study of the Effect of IW-1973 on the Exercise Capacity of Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:45 - Any
Updated:4/5/2019
Start Date:November 7, 2017
End Date:September 2019
Contact:Stella Ibebunjo, PhD
Email:IIbebunjo@cyclerion.com
Phone:857-338-3308

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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of Different Doses of IW-1973 Over 12 Weeks in Patients With Heart Failure With Preserved Ejection Fraction

The objective of the CAPACITY-HFpEF study is to evaluate the safety and efficacy of IW-1973
compared with placebo when administered daily for approximately 12 weeks to patients with
HFpEF. The study will evaluate the effect of oral IW-1973 on peak exercise capacity in
patients with HFpEF, with or without permanent or persistent atrial fibrillation.


Inclusion Criteria:

1. Patient is an ambulatory male or female ≥45 years old at the Screening Visit

2. Patient has heart failure with ejection fraction (EF) of ≥40%

3. Patient has a peak VO2 measuring <80% of age- and sex-adjusted normal values

4. Patient has evidence in medical history supporting clinical heart failure syndrome
consisting of at least 1 of the following:

1. Hospitalization or emergency department visit for heart failure within the past
year

2. Elevated B-type natriuretic peptide (BNP) or N-terminal pro b-type natriuretic
peptide (NT-proBNP) within the past 6 months

3. Echocardiographic evidence within the past 12 months of at least 2 of the
following: left ventricular (LV) hypertrophy, left atrial (LA) enlargement, or
diastolic dysfunction

4. Hemodynamic evidence of elevated filling pressures

5. Patient meets at least 2 of the following criteria at the Screening Visit:

1. Diagnosis of type 2 diabetes mellitus or prediabetes

2. History of hypertension

3. Body mass index (BMI) >30 kg/m2

4. Age ≥70 years

Exclusion Criteria:

1. Patient has had acute coronary syndrome or percutaneous coronary intervention within
30 days before Randomization

2. Patient has had cardiac transplantation or has cardiac transplantation planned during
the study

3. Patient has had cardiac artery bypass graft, cardiac mechanical support implantation,
or other cardiac surgery in the 3 months before the Screening Visit or planned during
the study

4. Patient has severe chronic obstructive coronary disease as defined by chronic oxygen
dependence

5. Patient had had heart failure hospitalization with discharge within 30 days before the
Screening Visit

6. Patient has a history of clinically significant hypersensitivity or allergies to any
of the inactive ingredients contained in the active or placebo drug products

7. Patient has previously received IW-1973 in a study, or received an investigational
drug during the 30 days or 5 half lives of that investigational drug (whichever is
longer) before the Screening Visit, or is planning to receive another investigational
drug at any time during the study

8. Patient is taking specific inhibitors of phosphodiesterase 5 (PDE5), nonspecific
inhibitors of PDE5, any supplements for the treatment of erectile dysfunction,
riociguat, or nitrates or nitric oxide (NO) donors in any form

9. Patient is taking strong cytochrome P450 3A (CYP3A) inhibitors

10. Women of childbearing potential must have a negative pregnancy test prior to
randomization and must agree to use protocol-specified contraception from the
Screening Visit through 60 days after the final dose of study drug

11. Male patients must be surgically sterile by vasectomy (conducted ≥60 days before the
Screening Visit or confirmed via sperm analysis) or must agree to use
protocol-specified contraception from the Screening Visit through 60 days after the
final dose of study drug

12. Other exclusion criteria per protocol
We found this trial at
59
sites
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
?
mi
from
Kansas City, KS
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
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Boston University School of Medicine A leader in medical education and research, Boston University School...
?
mi
from
Boston, MA
Click here to add this to my saved trials
3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
11701 San Jose Blvd # 32
Jacksonville, Florida 32223
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
1000 W Carson St
Torrance, California 90502
?
mi
from
Torrance, CA
Click here to add this to my saved trials
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
1407B Avenue F
Bogalusa, Louisiana 70427
?
mi
from
Bogalusa, LA
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
?
mi
from
Burlington, MA
Click here to add this to my saved trials
Burlington, Vermont 05405
?
mi
from
Burlington, VT
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80218
?
mi
from
Denver, CO
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Hialeah, Florida 33016
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
La Mesa, California 91941
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
Lancaster, Pennsylvania 17602
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
Little Rock, Arkansas 72204
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Littleton, Colorado 80120
?
mi
from
Littleton, CO
Click here to add this to my saved trials
?
mi
from
London,
Click here to add this to my saved trials
Los Angeles, California 90036
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
202 South Park Street
Madison, Wisconsin 53713
?
mi
from
Madison, WI
Click here to add this to my saved trials
Madison, Wisconsin 53706
(608) 263-2400
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
?
mi
from
Madison, WI
Click here to add this to my saved trials
Miami, Florida 33126
?
mi
from
Miami, FL
Click here to add this to my saved trials
National City, California 91950
?
mi
from
National City, CA
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
Northridge, California 91325
?
mi
from
Northridge, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73135
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
4200 West Memorial Road
Oklahoma City, Oklahoma 73120
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
9050 Pines Boulevard
Pembroke Pines, Florida 33024
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
?
mi
from
Peoria, IL
Click here to add this to my saved trials
2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85006
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Port Orange, Florida 32127
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
?
mi
from
Ridgewood, NJ
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Louis, Missouri 63106
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Scottsdale, Arizona 85259
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Springfield, Oregon 97477
?
mi
from
Springfield, OR
Click here to add this to my saved trials
9040 Jackson Ave
Tacoma, Washington 98431
(253) 968-1110
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Toledo, Ohio 43606
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tulsa, Oklahoma 74137
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Ypsilanti, Michigan 48197
?
mi
from
Ypsilanti, MI
Click here to add this to my saved trials