MedTrace Logo

Chlorhexidine Mouthwash and Oral Nitrate in Adults With Pulmonary Hypertension

NCT03787082 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-07-07

No results posted yet for this study

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.

Conditions

  • Pulmonary Hypertension
  • Heart Failure With Normal Ejection Fraction
  • Pulmonary Heart Disease and Diseases of Pulmonary Circulation

Interventions

DRUG

Nitrates

1,000 mg/11.18 mmol, oral

DRUG

Chlorhexidine Gluconate Mouthwash

chlorhexidine gluconate 0.12% (15mL) mouth rinse for 1 minute

DRUG

Placebo Mouthwash

sterile water (15mL) mouth rinse for 1 minute

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Pittsburgh

    collaborator OTHER

  • Gladwin, Mark, MD

    lead INDIV

Principal Investigators

  • Alison Morris, MD, MS · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03787082 on ClinicalTrials.gov