Hemodynamic Effects of a Novel Myeloperoxidase Inhibitor with Exercise in Heart Failure with Preserved Ejection Fraction

Overview

About this study

The purpose of this study is to determine the effect of a single dose of an oral acute MPO inhibitor drug on resting and exercise hemodynamics (arterial blood pressure and cardiac blood flow) in patients with heart failure with preserved ejection fraction (HFpEF).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  1. Males and females of non-childbearing potential confirmed at screening by fulfilling one of the following criteria:
  2. Postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the postmenopausal range
  3. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
  4. Age ≥ 30 years
  5. Symptoms of dyspnea (II-IV) at the time of screening
  6. EF ≥ 50% as determined on imaging study within 12 months of enrollment
  7. 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Barry Borlaug, M.D.

Closed for enrollment

Contact information:

Peter Mathiason

(507) 255-0473

Mathiason.Peter@mayo.edu

More information

Publications

Publications are currently not available