Chlorhexidine Mouthwash and Oral Nitrate in Adults With Pulmonary Hypertension

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, single-center study to examine distinguishing features of the structure and function of the oral and gut microbiome in volunteers with PH in the breakdown of oral nitrate and effect on hemodynamics.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gladwin, Mark, MD
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH); University of Pittsburgh
• Treatments: Chlorhexidine; Chlorhexidine gluconate

Criteria

Inclusion Criteria:

• Male or female, 18 years of age or older

• Undergoing clinical right heart catheterization or had a RHC in past 5 years if in PH group

• Pulmonary Hypertension: hemodynamically defined by a mean PAP ≥ 25 mm Hg and have a PVR > 3 Woods units and normal cardiac index (>2.0 L/min/m2)

• Healthy Control group: no history of or active cardiac or pulmonary disease

• Ability to provide written informed consent

Exclusion Criteria:

• Use of systemic antibiotics and/or chlorhexidine mouthwash within the previous three months

• Use of immune suppression (chemotherapy, oral prednisone greater than 20mg per day, etc) with in the previous three months

• Use of phosphodiesterase-5 inhibitors (tadalafil, sildenafil, etc) within 7 days before study drug administration

• Current pregnancy or lactation

• Uncontrolled systemic hypertension based on repeated measurement of sitting systolic blood pressure >185 mm Hg or sitting diastolic blood pressure >110 mm Hg

• Has chronic renal insufficiency as defined by serum creatinine >3 mg/dL in the last 6 months or requiring dialytic support as reported in the medical record

• Known history of left ventricular ejection fraction < 40% by multiple gated acquisition scan (MUGA), angiography, or echocardiography

• History of atrial septostomy

• Repaired or unrepaired congenital heart disease

• Pericardial constriction

• Restrictive or constrictive cardiomyopathy

• Symptomatic coronary disease with demonstrable ischemia

• Addition or change in dosing of hormonal contraception medications (OCP, IUD, Depo-Provera) in the past 4 weeks.

• Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study or would prevent completion of the study

• Active participation in other research studies with investigational drugs