Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

WITHDRAWN

Chlorhexidine Mouthwash and Oral Nitrate in Adults With Pulmonary Hypertension

Lead Sponsor:

Gladwin, Mark, MD

Collaborating Sponsors:

National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Pulmonary Hypertension

Heart Failure With Normal Ejection Fraction

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief 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 ef...

Detailed Description

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 ef...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2023

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT03787082

Start Date

December 1 2022

End Date

December 1 2023

Last Update

July 7 2022

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Cathy Kessinger

Pittsburgh, Pennsylvania, United States, 15213