NCT02256345|CompletedPhase 2Results
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Sponsor study identifier
interventional
12
1 country
1
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 30, 2014
Actual (reported)October 3, 2014
Actual (reported)January 2015
Date type not reportedThis date has not been verified as actual or estimated.
June 2016
Actual (reported)June 2016
Actual (reported)October 3, 2017
Actual (reported)Change in Peak Oxygen Uptake (VO2) From Baseline Upto 1 Week of Administration for Each Dose
Peak oxygen uptake (VO2) defined as the average value obtained during the last 30 seconds of exercise.
Baseline, end of week 1, end of week 2
Change in Vasodilatory Reserve for Each Dose
Baseline, end of week 1, end of week 2
Change in Mitochondrial Oxidative Capacity for Each Dose
Baseline, end of week 1, end of week 2
Change in Aortic Augmentation Index
Baseline, end of week 1, end of week 2
KNO3 will be given at a dose of 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated
KCl will be used as a placebo and will be given as 6 mmol twice daily for the first week, increasing to 6 mmol three times daily for the second week if well tolerated
Active Comparator
Placebo Comparator
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Zamani P, Tan V, Soto-Calderon H, Beraun M, Brandimarto JA, Trieu L, Varakantam S, Doulias PT, Townsend RR, Chittams J, Margulies KB, Cappola TP, Poole DC, Ischiropoulos H, Chirinos JA. Pharmacokinetics and Pharmacodynamics of Inorganic Nitrate in Heart Failure With Preserved Ejection Fraction. Circ Res. 2017 Mar 31;120(7):1151-1161. doi: 10.1161/CIRCRESAHA.116.309832. Epub 2016 Dec 7.
* Small sample size * Serial blood draws, which caused a decrease in hemoglobin concentration, which may have constrained the increase in VO2,peak and reduced the magnitude of the improvement in exercise capacity and quality of life.
Julio A Chirinos, MD
University of Pennsylvania
12 participants (actual enrollment reported by the registry).
First Submitted
September 30, 2014
First Posted
October 3, 2014
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction
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Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
October 3, 2017
Results First Posted
October 3, 2017
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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