Targeting Pulsatile Load to Increase Exercise Capacity and Quality of Life After Aortic Valve Replacement for Severe Aortic Stenosis (PULSE AS) (PULSE-AS)
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|ClinicalTrials.gov Identifier: NCT03483051|
Recruitment Status : Completed
First Posted : March 29, 2018
Results First Posted : March 11, 2020
Last Update Posted : June 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Stenosis||Drug: Potassium Nitrate Drug: Potassium Chloride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||In this phase IIb, double-blind, cross-over trial, we will assign 22 subjects who are post-TAVR for severe AS to: (A) Potassium nitrate administered by mouth at a dose of 6 mEq three times daily for 4 weeks, or (B) Potassium chloride (KCl) at identical doses. The order of the interventions (AB-BA design) will be randomized, with a 1-week washout period separating each intervention. A crossover design will enable each subject to receive both treatments.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Targeting Pulsatile Load to Increase Exercise Capacity and Quality of Life After Aortic Valve Replacement for Severe Aortic Stenosis (PULSE AS)|
|Actual Study Start Date :||May 1, 2018|
|Actual Primary Completion Date :||March 13, 2019|
|Actual Study Completion Date :||May 23, 2019|
Experimental: Potassium Nitrate (KNO3)
Capsules containing 18 mmoles of KNO3 per day, given as one capsule (6 mmoles) three times a day for 4 weeks.
Drug: Potassium Nitrate
Potassium nitrate capsules will consist of potassium nitrate (KNO3-) crystals [610 mg, corresponding to 6.03 mmoles of NO3-] with 190mg of lactose monohydrate, spray dried, NF. The dose for this trial will be 18 mmoles of NO3-per day, given as one capsule (6 mmoles) three times a day.
Sham Comparator: Potassium Chloride
Capsules containing 18 mmoles of KCl per day, given as one capsule (6 mmoles) three times a day for 4 weeks.
Drug: Potassium Chloride
Potassium chloride capsules will consist of potassium chloride (KCl), granular, USP (450mg) plus lactose monohydrate, spray dried, NF (300mg). The dose for this trial will be 18 mmoles of KCl per day, given as one capsule (6 mmoles) three times a day.
- Total Work Performed During a Maximal-effort Exercise Test [ Time Frame: 9 weeks ]The effect of KNO3 on exercise capacity, quantified as Total work performed during a maximal-effort exercise test;
- Peak Oxygen Uptake (VO2) During a Maximal Effort Exercise Test [ Time Frame: 9 weeks ]The effect of KNO3 on exercise capacity, quantified as: Peak oxygen consumption (VO2) during a symptom-limited maximal effort exercise test.
- Quality of Life Score [ Time Frame: 9 weeks ]The effect of KNO3 on quality of life, assessed using the Kansas City Cardiomyopathy Questionnaire.
- Systemic Vasodilator Response to Exercise [ Time Frame: 9 weeks ]The effect of KNO3 on systemic vasodilator response, measured by change in systemic vascular resistance, during a symptom-limited maximal exercise test,
- Left Ventricle Diastolic Function [ Time Frame: 9 weeks ]The effect of KNO3 on left ventricle diastolic filling parameters (measured with echocardiography at rest and after peak exercise)
- Myocardial Systolic Strain [ Time Frame: 9 weeks ]The effect of KNO3 on myocardial strain (assessed with speckle-tracking echocardiography)
- Late Systolic Left Ventricle Load [ Time Frame: 9 weeks ]The effect of KNO3 on last systolic left ventricle load from wave reflections (assessed via comprehensive aortic pressure-flow regulations, using arterial tonometry and Doppler echocardiography)
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): NCT03483051
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Julio Chirinos, MD||University of Pennsylvania|