Phase 2
N=3
Targeting Pulsatile Load to Increase Exercise Capacity and Quality of Life After Aortic Valve Replacement for Severe Aortic Stenosis (PULSE AS)
Aortic Valve Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT03483051 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Total Work Performed During a Maximal-effort Exercise Test
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Potassium Nitrate (Drug); Potassium Chloride (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Work Performed During a Maximal-effort Exercise Test |
— | — |
| PRIMARY Peak Oxygen Uptake (VO2) During a Maximal Effort Exercise Test |
— | — |
| PRIMARY Quality of Life Score |
— | — |
| SECONDARY Systemic Vasodilator Response to Exercise |
— | — |
| SECONDARY Left Ventricle Diastolic Function |
— | — |
| SECONDARY Myocardial Systolic Strain |
— | — |
| SECONDARY Late Systolic Left Ventricle Load |
— | — |
Summary
The current trial is designed to assess the safety and efficacy of sustained oral administration of inorganic nitrate in patients with severe aortic stenosis and to assess the mechanisms by which inorganic nitrate enhances oxygen uptake and exercise capacity in this population.
Eligibility Criteria
Inclusion Criteria
- Adults aged 50-90 years of age
- Diagnosis of severe aortic stenosis prior to aortic valve repair
- Successful trancatheter aortic valve repair via transfemoral procedural approach or successful surgical aortic valve repair at least three months prior to enrollment
- Stable medical therapy: no addition/removal/changes in anti-hypertensive medications, or beta-blockers in the preceding 30 days.
Exclusion Criteria
- Supine systolic blood pressure (SBP) 160 mmHg OR DBP > 100 mmHg
- Pregnancy. Women of childbearing potential will undergo a pregnancy test during the screening visit
- Atrial fibrillation within the prior 8 weeks before enrollment
- Inability/unwillingness to exercise
- Moderate or greater mitral regurgitation or aortic/peri-valvular regurgitation, any degree of mitral stenosis, severe right-sided valvular disease, or presence of a mitral prosthetic valve.
- Moderate or severe patient prosthesis mismatch, as defined by Effective Orifice Area Index 3x ULN, Albumin 5% at baseline visit
- Serum K>5.0 mEq/L
- Severe right ventricular dysfunction.
- Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the study.
Data sourced from ClinicalTrials.gov (NCT03483051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.