Pharmacokinetics, Pharmacodynamics, and Impact of Inorganic Nitrate on Exercise in HFpEF
Completed · Phase 2 · Has a placebo group
Conditions studied: Heart Failure, Diastolic Heart Failure
In brief
This study will be performed to determine the safety, tolerability, and dose-response to inorganic nitrate on exercise capacity in HFpEF. There are two primary goals for this study: 1. Determine the population-specific pharmacokinetics and dose of KNO3 that can be safely given to subjects with HFpEF. 2. Determine if there is a dose-response effect of nitrate supplementation on exercise capacity, evidenced by peak oxygen consumption (peak VO2), and physiologic adaptations to exercise.
Key facts
- Study ID
- NCT02256345
- Run by
- University of Pennsylvania
- People needed
- 12
- Starts
- 2015-01-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2017-10-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- NYHA Class II-III symptoms.
- LV EF > 50%.
- Stable medical therapy for at least 1 month.
- Evidence of significant diastolic dysfunction, meeting the European Society of Echocardiography criteria for HFpEF.
You may not qualify if…
- Any rhythm other than sinus with native conduction.
- Inability to exercise.
- Moderate or greater valvular disease.
- Hypertrophic, infiltrative, or inflammatory cardiomyopathy.
- Pericardial disease.
- Current angina.
- Acute coronary syndrome or coronary intervention within the past 2 months.
- Primary pulmonary arteriopathy.
- Clinically significant lung disease.
- Ischemia on stress testing without subsequent revascularization.
- Treatment with phosphodiesterase inhibitors that cannot be withheld.
- Treatment with organic nitrates or allopurinol.
- Significant liver disease impacting synthetic function or volume control.
- Poor echocardiographic windows.
- eGFR < 30 mL/min/m2 or Cr >2.5.
- Current smoking.
- Alcohol dependency.
- History of Barret's esophagus.
- G6PD deficiency
- Methemoglobinemia - baseline methemoglobin level >3% prior to any study medication.
Where it is running
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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