MPO Inhibitor A_Zeneca for HFpEF

• Status: Recruiting
• Trial end date: 2022-04-21
• Target enrollment: 0
• Participant gender: All

Summary

Researchers are studying the effect of a single dose of oral myeloperoxidase on heart failure versus placebo.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic

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