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A Study of Oral Nitrate in Adults With Pulmonary Hypertension With Heart Failure and Preserved Ejection Fraction

NCT02980068 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2022-03-22

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 healthy adult normal volunteers compared to volunteers with PH-HFpEF in the breakdown of oral nitrate.

Conditions

  • Pulmonary; Hypertension
  • Heart Failure
  • Preserved Ejection Fraction

Interventions

DRUG

15N Nitrate

1,000 mg/11.8 mmol, oral, on day one, hour zero

DRUG

14N Nitrate

1,000 mg/11.18 mmol, oral, on day hour, hour zero

Sponsors & Collaborators

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

    collaborator NIH

  • Gladwin, Mark, MD

    lead INDIV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2022-02-25
Completion
2022-02-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02980068 on ClinicalTrials.gov