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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03254485
Recruitment Status : Completed
First Posted : August 18, 2017
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Cyclerion Therapeutics

Study Description
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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
Heart Failure With Preserved Ejection Fraction Drug: IW-1973 Drug: Placebo Oral Tablet Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : November 7, 2017
Actual Primary Completion Date : August 19, 2019
Actual Study Completion Date : August 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs [ Time Frame: From Randomization through Follow-Up Visit (Day 113 ± 7 days) ]
  2. Change From Baseline in Peak VO2 (CPET) at Week 12 [ Time Frame: Baseline, Week 12 ]

Secondary Outcome Measures :
  1. Change From Baseline in 6-Minute Walk Test (6MWT) Distance at Week 12 [ Time Frame: [Baseline, Week 12] ]
  2. Change From Baseline in Ventilatory Efficiency at Week 12 [ Time Frame: [Baseline, Week 12] ]
  3. Number of CPET Responders at Week 12 [ Time Frame: [Week 12] ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254485


Locations
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Sponsors and Collaborators
Cyclerion Therapeutics
More Information
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Responsible Party: Cyclerion Therapeutics
ClinicalTrials.gov Identifier: NCT03254485    
Other Study ID Numbers: C1973-204
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases