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

Sponsor
Cyclerion Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT03254485
Collaborator
(none)
196
Enrollment
62
Locations
2
Arms
21.4
Actual Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
196 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 7, 2017
Actual Primary Completion Date :
Aug 19, 2019
Actual Study Completion Date :
Aug 19, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: IW-1973 High Dose

Drug: IW-1973
Oral Tablet
Placebo Comparator: Placebo

Placebo to match experimental drug

Drug: Placebo Oral Tablet
Oral Tablet

Outcome Measures

Primary Outcome Measures

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs [From Randomization through Follow-Up Visit (Day 113 ± 7 days)]

  2. Change From Baseline in Peak oxygen consumption (VO2) as determined by CPET at Week 12 [Baseline, Week 12]

Secondary Outcome Measures

  1. Change From Baseline in 6-Minute Walk Test (6MWT) Distance at Week 12 [[Baseline, Week 12]]

  2. Change From Baseline in Ventilatory Efficiency at Week 12 [[Baseline, Week 12]]

  3. Number of CPET Responders at Week 12 [[Week 12]]

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

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

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

  7. 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

  8. Hemodynamic evidence of elevated filling pressures

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

  10. Diagnosis of type 2 diabetes mellitus or prediabetes

  11. History of hypertension

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

  13. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arizona Arrhythmia Research Center Phoenix Arizona United States 85016
2 Mayo Clinic Scottsdale Arizona United States 85259
3 University of Arizona Tucson Arizona United States 85724
4 Cardiology and Medicine Clinic Little Rock Arkansas United States 72204
5 JEHM La Mesa California United States 91941
6 Axis Clinical Trials Los Angeles California United States 90036
7 JEHM National City California United States 91950
8 Valley Clinical Trials Northridge California United States 91325
9 Stanford University Palo Alto California United States 94305
10 Harbor UCLA Medical Center Torrance California United States 90509
11 Aurora Denver Cardiology Denver Colorado United States 80218
12 South Denver Cardiology Associates Littleton Colorado United States 80120
13 Holy Cross Hospital Fort Lauderdale Florida United States 33308
14 New Generation of Medical Research Hialeah Florida United States 33016
15 East Coast Institute for Research Jacksonville Florida United States 32216
16 PCRS Network, LLC Miami Florida United States 33126
17 Broward Research Center Pembroke Pines Florida United States 33024
18 Progressive Medical Research Port Orange Florida United States 32127
19 St. Luke's Regional Medical Center Boise Idaho United States 83712
20 Northwestern University Chicago Illinois United States 60611
21 Unity Point Health - Methodist Hospital Peoria Illinois United States 61602
22 Franciscan Physician Network - Indiana Heart Physicians Indianapolis Indiana United States 46237
23 University of Kansas Medical Center Kansas City Kansas United States 66160
24 Lousiana Heart Center Bogalusa Louisiana United States 70427
25 Tufts Medical Center Boston Massachusetts United States 02111
26 Massachusetts General Hospital Boston Massachusetts United States 02114
27 Boston University School of Medicine Boston Massachusetts United States 02118
28 Lahey Clinic Burlington Massachusetts United States 01805
29 Michigan Heart Ypsilanti Michigan United States 48197
30 University of Minnesota Minneapolis Minnesota United States 55455
31 Mayo Clinic Rochester Minnesota United States 55905
32 VA Healthcare John Cochran Medical Center Saint Louis Missouri United States 63106
33 Washington University Saint Louis Missouri United States 63110
34 The Valley Hospital Ridgewood New Jersey United States 07450
35 Mount Sinai School of Medicine New York New York United States 10025
36 Duke University Medical Center Durham North Carolina United States 27710
37 Ohio State University Medical Center (OSUMC) Columbus Ohio United States 43210
38 ProMedica Toledo Hospital Toledo Ohio United States 43606
39 South Oklahoma Heart Research Oklahoma City Oklahoma United States 73135
40 Newton Clinical Research Oklahoma City Oklahoma United States 73159
41 Oklahoma Heart Institute Tulsa Oklahoma United States 74104
42 Oregon Health & Science University (OHSU) Portland Oregon United States 97239
43 PeaceHealth, Sacred Heart Physicians Springfield Oregon United States 97477
44 Research Institute of Lancaster General Health Lancaster Pennsylvania United States 17602
45 Drexel University College of Medicine Philadelphia Pennsylvania United States 19102
46 Vanderbilt University Medical Center Nashville Tennessee United States 37232
47 North Dallas Research Associates Dallas Texas United States 75069
48 Texas Health Research and Education Insitute Dallas Texas United States 75231
49 Southwest Family Medicine Associates Dallas Texas United States 75235
50 Baylor University Medical Center Dallas Texas United States 75246
51 University of Texas Southwestern Medical Center Dallas Texas United States 75390
52 Schnitzler Cardiovascular Consultants San Antonio Texas United States 78229
53 University of Vermont Medical Center Burlington Vermont United States 05401
54 Virginia Commonwealth University Medical College of Virginia Richmond Virginia United States 23298
55 Madigan Army Medical Center Tacoma Washington United States 98431
56 Unity Point Health Madison Wisconsin United States 53713
57 University of Wisconsin - Madison Madison Wisconsin United States 53792
58 London Health Sciences Centre London Ontario Canada N6A 5A5
59 Mount Sinai Hospital Toronto Ontario Canada M5G 1X5
60 Ecogene-21 Chicoutimi Quebec Canada G7H 7K9
61 CIUSSS de l'Estrie - CHUS Sherbrooke Quebec Canada J1G 2E8
62 Institut Universitaire de Cardiologie et de Pneumologie De Quebec Québec Canada G1V 4G5

Sponsors and Collaborators

  • Cyclerion Therapeutics

Investigators

  • Study Director: Jelena Seferovic, MD PhD, Cyclerion Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cyclerion Therapeutics
ClinicalTrials.gov Identifier:
NCT03254485
Other Study ID Numbers:
  • C1973-204
First Posted:
Aug 18, 2017
Last Update Posted:
Feb 5, 2021
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Cyclerion Therapeutics
Heart Failure
Cardiovascular
HF
HFpEF
Additional relevant MeSH terms:
Heart Failure
Praliciguat

Study Results

No Results Posted as of Feb 5, 2021