Chlorhexidine Mouthwash and Oral Nitrate in Adults With Pulmonary Hypertension

Withdrawn before enrolling · Phase 1 · Has a placebo group

Conditions studied: Pulmonary Hypertension, Heart Failure With Normal Ejection Fraction, Pulmonary Heart Disease and Diseases of Pulmonary Circulation

In brief

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.

Key facts

Study ID

NCT03787082

Run by

Gladwin, Mark, MD

People needed

0

Starts

2022-12-01

Expected to finish

2023-12-01

Last updated by the study team

2022-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cathy Kessinger — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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