Status:
COMPLETED
Pharmacokinetics, Pharmacodynamics, and Impact of Inorganic Nitrate on Exercise in HFpEF
Lead Sponsor:
University of Pennsylvania
Conditions:
Heart Failure
Diastolic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
This study randomized subjects to either placebo (n=3) or KNO3 (n=9) given a sequential dosing regimen: 6 mmol twice daily for 1 week followed by dose escalation to 6 mmol thrice daily for 1 week). Al...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02256345
Start Date
January 1 2015
End Date
June 1 2016
Last Update
October 3 2017
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104