Chlorhexidine Mouthwash and Oral Nitrate in Adults With Pulmonary Hypertension
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|ClinicalTrials.gov Identifier: NCT03787082|
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Heart Failure With Normal Ejection Fraction Pulmonary Heart Disease and Diseases of Pulmonary Circulation||Drug: Nitrates Drug: Chlorhexidine Gluconate Mouthwash Drug: Placebo Mouthwash||Phase 1|
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.
The investigators will enroll 40 PH patients over three years. 5 healthy participants will be enrolled as controls. Participants will receive a single dose of the study drug,:14N Sodium Nitrate(1000mg): standard sodium nitrate, and all will receive one dose of CLA 3g. CLA will be obtained from GNC (General Nutrition Corporation) and given once. Participants will be randomized to receive chlorhexidine gluconate 0.12% (15mL) or placebo to rinse their mouth with for 1 minute.
Oral samples will be collected pre- and post-chlorhexidine treatments and stool samples will be collected post-chlorhexidine treatment.
Right heart catheterization will be performed for clinical or research purposes.
The RHC done (in the last 5 years) that establishes inclusion is not the same RHC done as part of the study in most cases. If there is a strong suspicion of PH based on echocardiography in a patient who has not had a clinical RHC, the first hemodynamic measurements obtained in the clinical RHC will establish inclusion and the RHC study procedures will be performed following confirmation of inclusion.
Participants for whom the RHC done in the study is considered a clinical RHC will be participants who do have an additional follow up RHC scheduled.
Participants for whom the RHC done in the study is considered a research RHC will be those who do not have an additional follow RHC scheduled or who are considered healthy and have not had an RHC before.
Catheterization will generally be performed via the right internal jugular vein access with the assistance of fluoroscopy, if needed. Once the pulmonary arterial (PA) catheter has been placed in proper position, measured values will be obtained. The investigators often perform simultaneous measurement of right atrial pressure and distal pressure (PAP/PAWP) using two transducers in order to assess both pressures during vasodilator challenge, or other confrontational testing. An initial hemodynamic profile will be obtained.
With the right heart catheter still in place, participants will be randomized to either chlorhexidine mouthwash or placebo, then after 30 minutes, all will receive 14N oral nitrate and CLA. A repeat hemodynamic profile will be performed after two hours. Nitrate metabolites in plasma will be measured at time 0, 2, and 6 hrs after 14N nitrate dose. Urine nitrite and nitrate will be measured at 0 and 6 hours. Participants will be monitored with continuous pulse oximetry and EKG monitoring. Blood pressure measurements will be performed every 15 minutes during the catheterization. Pressure-volume loop and impedance analysis will be performed at the time of the right heart catheterization (RHC) using the micromanometer catheter technique to simultaneously measure RV pressure and pulmonary blood flow.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Participants will receive open label nitrate and be randomly assigned to either chlorhexidine mouthwash or placebo mouthwash. The participant and investigator will be blinded to which mouthwash the participant is randomized.|
|Official Title:||A Randomized Trial of Chlorhexidine Mouthwash and Oral Nitrate in Adults With Pulmonary Hypertension|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
Experimental: Chlorhexidine Gluconate Mouthwash
rinse with chlorhexidine gluconate 0.12% (15mL) mouthwash before administration of 14N Sodium Nitrate 1,000 mg/11.18 mmol, oral
1,000 mg/11.18 mmol, oral
Other Name: 14N Sodium Nitrate
Drug: Chlorhexidine Gluconate Mouthwash
chlorhexidine gluconate 0.12% (15mL) mouth rinse for 1 minute
Other Name: Chlorhexidine mouthwash
Placebo Comparator: Placebo Mouthwash
rinse with placebo mouthwash (15mL) before administration of 14N Sodium Nitrate 1,000 mg/11.18 mmol, oral
1,000 mg/11.18 mmol, oral
Other Name: 14N Sodium Nitrate
Drug: Placebo Mouthwash
sterile water (15mL) mouth rinse for 1 minute
Other Name: Sterile Water
- Change in Plasma Nitrate [ Time Frame: At baseline and 2 hours post drug administration ]
- Change in Urine Nitrate [ Time Frame: At baseline and 2 hours post drug administration ]
- Change in Plasma Nitrate [ Time Frame: At baseline and 6 hours post drug administration ]
- Change in Urine Nitrate [ Time Frame: At baseline and 6 hours post drug administration ]
- Change in Plasma Nitrate [ Time Frame: At 2 hours post drug administration and 6 hours post drug administration ]
- Change in Urine Nitrate [ Time Frame: At 2 hours post drug administration and 6 hours post drug administration ]
- Change in Pulmonary Vascular Resistance (PVR) [ Time Frame: At baseline and 2 hours post drug administration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787082
|Contact: Noel Britton, MPHemail@example.com|
|Contact: Cathy Kessinger, RNfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Alison Morris, MD, MS||University of Pittsburgh|