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MPO Inhibitor A_Zeneca for HFpEF

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ClinicalTrials.gov Identifier: NCT03611153
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : January 26, 2023
Sponsor:
Collaborator:
National Center for Advancing Translational Sciences (NCATS)
Information provided by (Responsible Party):
Barry Borlaug, Mayo Clinic

Study Description
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Brief Summary:
Researchers are studying the effect of a single dose of oral myeloperoxidase on heart failure versus placebo.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: AZD4831 Oral Myeloperoxidase Inhibitor Drug: Placebo oral capsule Phase 1 Phase 2

Detailed Description:
Enroll subjects with a normal ejection fraction referred to the catheterization laboratory for evaluation of breathlessness or shortness of breath. Perform safety lab sampling, echocardiography, arterial tonometry for pulse wave analysis, and assessment of endothelial function prior to administration of study drug. During the catheterization researchers will perform blood draws, assess baseline exercise capacity at rest and during exercise. Researchers will also do an echocardiogram to take measurements of the heart. Subjects will be randomized to one of two groups, Oral Myeloperoxidase Inhibitor or placebo group. Study drug or placebo will be administered followed by a repeat of the baseline catheterization assessments. At the conclusion of the second exercise test the subject will be moved to a room and monitored overnight for safety. Repeat blood draws, echocardiogram, endothelial function test, and heart monitoring will be completed. The subject will be asked to follow up with the researchers between 9-14 days after the study drug dosage. The subjects history and blood work will be completed at that visit.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single Administration of study drug
Masking: Double (Participant, Investigator)
Masking Description: Only research pharmacy staff will be aware of randomization scheme and all study personnel and subjects will remain blinded.
Primary Purpose: Treatment
Official Title: Hemodynamic Effects of a Novel Myeloperoxidase Inhibitor With Exercise in Heart Failure With Preserved Ejection Fraction - A Randomized, Double-Blind, Placebo Controlled Proof of Principle Study
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : February 11, 2022
Actual Study Completion Date : February 24, 2022

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: AZD4831 Oral myeloperoxidase inhibitor
Patient may take 30 mg of oral myeloperoxidase inhibitor following baseline right heart catheterization.
 Drug: AZD4831 Oral Myeloperoxidase Inhibitor
A single administration dose of 30 mg oral MPO inhibitor given orally following baseline, resting and exercise testing in patients during right heart catheterization.
Other Name: Oral MPO inhibitor AZD4831
Placebo Comparator: Placebo
Patient may take 30 mg of placebo oral capsule following baseline right heart catheterization.
 Drug: Placebo oral capsule
A single administration dose of 30 mg placebo given orally following baseline, resting and exercise testing in patients during right heart catheterization.


Outcome Measures
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Primary Outcome Measures :
  1. Exercise Pulmonary capillary wedge pressure (PCWP) [ Time Frame: Baseline ]
    Exercise PCWP values at 20 Watt workload. Measured in mmHg. Normal values are 4-12 mmHg

  2. Exercise Pulmonary capillary wedge pressure (PCWP) [ Time Frame: 30min ]
    Exercise PCWP values at 20 Watt workload. Measured in mmHg. Normal values are 4-12 mmHg


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females of non-childbearing potential
  2. Age ≥ 30 years
  3. Symptoms of dyspnea (II-IV) at the time of screening
  4. EF ≥ 50% as determined on imaging study within 12 months of enrollment
  5. Catheterization documented elevated filling pressures at rest (PCWP ≥15) or with exercise (PCWP ≥25)

Exclusion Criteria:

  1. Use of nitrates, phosphodiesterase 5 inhibitors or other NO-providing therapy in the past 24 hours of screening
  2. Significant valvular disease (>moderate left-sided regurgitation, >mild stenosis)
  3. Requirement of intravenous heparin at the start of case
  4. Severe pulmonary parenchymal disease
  5. Acute coronary syndrome or coronary disease requiring revascularization in the judgement of investigators
  6. Resting systolic blood pressure < 100 mmHg
  7. Constrictive pericarditis
  8. Infiltrative, restrictive, or hypertrophic obstructive cardiomyopathies
  9. Previous anaphylaxis to any drug
  10. Pregnancy or breastfeeding mothers
  11. High Output heart failure
  12. Active thyroid disease
  13. Treatment with a new chemical entity (defined as a compound which has not been approved for marketing) within the preceding 3 months
  14. Patients with any prior allergy to propylthiouracil
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): NCT03611153


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Center for Advancing Translational Sciences (NCATS)
Investigators
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Principal Investigator: Barry A Borlaug, M.D. Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Barry Borlaug, Principle Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03611153    
Other Study ID Numbers: 17-002907
UL1TR000135 ( U.S. NIH Grant/Contract )
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
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
Keywords provided by Barry Borlaug, Mayo Clinic:
Heart Failure
Ejection Fraction
Preserved
Myeloperoxidase Inhibitor
Exercise
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases