Status:
COMPLETED
Targeting Pulsatile Load to Increase Exercise Capacity and Quality of Life After Aortic Valve Replacement for Severe Aortic Stenosis (PULSE AS)
Lead Sponsor:
University of Pennsylvania
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
50-90 years
Phase:
PHASE2
Brief 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 inor...
Detailed Description
This is a randomized double-blind crossover clinical trial, in which 22 subjects who underwent transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) three or more months prior ...
Eligibility Criteria
Inclusion
- 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) \< 100 mmHg OR supine diastolic blood pressure (DBP) \<60 mmHg
- Poorly controlled hypertension, as defined as 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 \< 0.85 cm2/m2
- 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 as defined by: Chronic Obstructive pulmonary disease meeting Stage III or greater GOLD criteria, treatment with oral steroids within the past 6 months for an exacerbation of obstructive lung disease, or the use of daytime supplemental oxygen
- Ischemia on stress testing without subsequent revascularization (during the screening visit)
- Treatment with phosphodiesterase inhibitors that cannot be withheld
- Treatment with organic nitrates
- Significant liver disease impacting synthetic function or volume control (ALT/AST \> 3x ULN, Albumin \<3.0 g/dL)
- eGFR \< 30 mL/min/1.73 m2
- G6PD deficiency. For males of African, Asian or Mediterranean decent, this will be evaluated prior to drug administration. A qualitative test positive for deficiency or a quantitative test with clinically significant G6PD deficiency (\<60% of normal activity) will prompt exclusion from the trial (prior to drug administration).
- History of methemoglobinemia or methemoglobin level \>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.
Exclusion
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03483051
Start Date
May 1 2018
End Date
May 23 2019
Last Update
June 17 2020
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104