Hemodynamic Effects Of A Novel Myeloperoxidase Inhibitor With Exercise In Heart Failure With Preserved Ejection Fraction
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-002907
NCT ID: NCT03611153
Sponsor Protocol Number: 17-002907
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
- Males and females of non-childbearing potential confirmed at screening by fulfilling one of the following criteria:
- 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
- Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
- Age ≥ 30 years
- Symptoms of dyspnea (II-IV) at the time of screening
- EF ≥ 50% as determined on imaging study within 12 months of enrollment
- Catheterization documented elevated filling pressures at rest (PCWP ≥15) or with exercise (PCWP ≥25)
Exclusion Criteria
- Use of nitrates, phosphodiesterase 5 inhibitors or other NO-providing therapy in the past 24 hours of screening
- Significant valvular disease (>moderate left-sided regurgitation, >mild stenosis)
- Requirement of intravenous heparin at the start of case
- Severe pulmonary parenchymal disease
- Acute coronary syndrome or coronary disease requiring revascularization in the judgement of investigators
- Resting systolic blood pressure < 100 mmHg
- Constrictive pericarditis
- Infiltrative, restrictive, or hypertrophic obstructive cardiomyopathies
- Previous anaphylaxis to any drug
- Pregnancy or breastfeeding mothers
- High Output heart failure
- Active thyroid disease
- Treatment with a new chemical entity (defined as a compound which has not been approved for marketing) within the preceding 3 months
- 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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Barry Borlaug, M.D. |
Closed-enrolling by invitation |
|
More information
Publications
Publications are currently not available