Pressure Assessment to Improve Outcomes After TAVR: a Registry

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Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation. CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System SMT Embolic Deflection CE Mark Trial DEFLECT I Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight Nitinol Circular Blade Functional Assessment In TAVI: FAITAVI CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. POLESTAR Trial – An International Multi-center Early Discharge TAVI Program REPRISE EDGE 29 mm EU Study The CONFIDENCE Registry Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System – The Engager European Pivotal Trial Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement The PROTEMBO SF Trial Adjuvant Radiation in Aortic Valvuloplasty – ARAVA Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications Supra-Annular vs. Annular ValvEs for Small Annuli Heart Leaflet Technologies Valve Study A Study to Evaluate the Neuro-embolic Consequences of TAVR Femoral vs Radial Approach and MRI Evaluation of Strokes Mortality Post-TAVI and Correlation With Haemodynamic Parameters. 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Coupling Modification Evaluated by PRAM During TAVI Procedure CoreValve Advance International Post Market Study HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON SWISS TAVI Registry CoreValve™ Evolut R™ FORWARD Study Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial Follow-up After TAVR Without Systematic Intensive Care Unit Admission ACURATE NEO/TF Transcatheter Heart Valves and Non-inferiority Versus Medtronic CoreValve Systems CoreValve™ Evolut R™ 34 mm System Registry (CoreValve34) Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR) ACURATE TA™ Valve Implantation Registry: SAVI 2 Colibri Transcatheter Aortic Heart Valve System Study HLT Meridian Valve CE Mark Trial Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device Reactive Oxygen Species Following Aortic Valve Replacement Biological Factors Associated With Subclinical Valvular Thrombosis Hemodynamic Comparison of Tissue Aortic Valves Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis The Effects of High Spinal Anesthesia on Heart Function, Stress Response and Pain Control in Aortic Valve Surgery A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis Phono- and Electrocardiogram Assisted Detection of Valvular Disease The Medtronic TAVR 2.0 US Clinical Study PREVAIL-J – Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan) Regression of Myocardial Fibrosis After Aortic Valve Replacement Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis THE ALIGN-AS TRIAL: JenaValve Pericardial TAVR Aortic Stenosis Study Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis Valvuloplasty Scoring Balloon Catheter First-in-Man Study Effect of Angiotensin II Receptor Blockers (ARB) on Left Ventricular Reverse Remodelling After Aortic Valve Replacement in Severe Valvular Aortic Stenosis Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome – (German Pilot) Quality of Care in AS IMPULSE Study Biomarkers in Aortic Stenosis – B.A.S.S. 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Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis Evaluation of BAV in Different Hemodynamic Entities of Severe AS Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic Severe Aortic Stenosis Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Rehabilitation in Aortic Stenosis Patients Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography Podocan and Wnt Pathway in Left Ventricular Remodeling of Aortic Stenosis Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease Statin Therapy in Asymptomatic Aortic Stenosis Validation of the “TASQ” in Patients Undergoing SAVR or TF-TAVI Analysis and Comparative Evaluation of Aortic Calcium by Computed Tomography and Histopathology in Patients With Aortic Stenosis Improving Echo Measurements in the Diagnosis of Aortic Stenosis accuRate Evaluation of Benefit With Optimal Medical Treatment With or With-Out Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis – REBOOT-PARADOX Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction Microvascular Dysfunction in Aortic Stenosis Percutaneous Aortic 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PCSK9 Inhibitors in the Progression of Aortic Stenosis Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis. 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Brief Title

Pressure Assessment to Improve Outcomes After TAVR: a Registry

Official Title

Pressure Assessment to Improve Outcomes After TAVR: a Registry

Brief Summary

      At the Malcom Randall Veterans Affairs Medical Center (MRVAMC), invasive cardiac pressures
      are routinely recorded after transcatheter aortic valve replacement (TAVR) procedures. Our
      research has disclosed that patients with abnormal hemodynamics (narrow aortic to ventricular
      end-diastolic pressure difference, indexed to heart rate) suffer from high long-term
      mortality, compared with patients with normal hemodynamics.This hemodynamic value can be
      referred to as the aortoventricular index (AVi). Hypertension and diastolic dysfunction are
      highly co-morbid conditions among these patients. The selective aldosterone receptor
      antagonist eplerenone (Inspra) is approved for use in the treatment of hypertension. Research
      also supports that eplerenone may be able to improve diastolic function.

      This prospective study is interested in determining 1) the tolerability of eplerenone, and 2)
      feasibility of administering the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) among
      subject with abnormal cardiac hemodynamics after TAVR. This study will set the stage for a
      pilot randomized trial to evaluate eplerenone versus placebo among patients with abnormal
      hemodynamics after TAVR.

Detailed Description

      Our research has disclosed that patients who have abnormal invasive cardiac hemodynamics
      (narrow aortic to ventricular end-diastolic pressure difference, indexed to heart rate) after
      TAVR suffer from poor long-term survival. This hemodynamic value can be referred to as the
      aortoventricular index (AVi). In a single center observational study, the 2-year mortality
      rate for patient with a value ≥0.6 mm Hg/bpm was 25% compared with 36% for patients with a
      value <0.6 mm Hg/bpm. An abnormal AVi was an independent predictor for poor survival.
      Hypertension and diastolic dysfunction are 2 highly co-morbid conditions among these
      patients. Currently, there is lack of appreciation that pressure measurements obtained at the
      time of TAVR can provide long-term prognostic value. There is also a lack of understanding on
      how to improve outcomes and quality of life among such patients.

      Eplerenone is a selective aldosterone receptor antagonist approved for use for treatment of
      hypertension. Animal studies have shown that aldosterone receptor antagonists can decrease
      interstitial myocardial fibrosis. The non-selective aldosterone receptor antagonist,
      spironolactone 25 mg daily compared with placebo was shown to improve diastolic function, as
      assessed by echocardiography, among 28 elderly subjects. A meta-analysis of eleven studies in
      942 subjects found that aldosterone receptor antagonists improve diastolic function and
      markers of cardiac fibrosis without significant changes to left ventricular mass or
      dimensions. In a randomized controlled trial, eplerenone was found to be safely tolerated
      among asymptomatic patients with moderate to severe aortic stenosis.

Study Phase

Early Phase 1

Study Type

Interventional

Primary Outcome

Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Summary Score

Secondary Outcome

 Kansas City Cardiomyopathy Questionnaire (KCCQ-12)-Physical Limitation Score

Condition

Hypertension

Intervention

Eplerenone

Study Arms / Comparison Groups

 Eplerenone
Description:  Eplerenone 50 mg daily, administered orally for 8 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

12

Start Date

June 3, 2019

Completion Date

February 27, 2020

Primary Completion Date

February 20, 2020

Eligibility Criteria

        1. Enroll 10 subjects with hypertension and abnormal hemodynamics after TAVR.

          2. This is a greater than minimal risk study.

               1. Inclusion criteria:

                    -  TAVR procedure performed at the Malcom Randall VA Medical Center within the
                       last 2 years.

                    -  Intracardiac pressures recorded 5 to 10 minutes after TAVR and AVi < 0.6 mm
                       Hg/bpm.

                    -  History of hypertension, taking anti-hypertensive medications, or recent
                       systolic blood pressure ≥130 mm Hg.

               2. Exclusion criteria:

                    -  Serum potassium >5.5 mEq/L at initiation.

                    -  Concomitant administration of strong CYP3A inhibitor (i.e. ketoconazole,
                       itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and
                       nelfinavir).

                    -  Type 2 diabetes with microalbuminuria.

                    -  Serum creatinine >2.0 for men and >1.8 for women.

                    -  Creatinine clearance <50 cc/min.

                    -  Concomitant administration of potassium supplements or potassium-sparing
                       diuretics.

          3. Subjects who are eligible to participate and signed an informed consent will be given
             eplerenone 50 mg daily. Study drug (eplerenone) will be paid by the North Florida
             Foundation for Research and Education for the duration of the study.

             a. Down-titration or termination of non-essential anti-hypertensive agents is
             permissible so that eplerenone does not result in hypotension. Essential medications
             are as follows:

               -  Angiotensin converting enzyme inhibitors (ACE-inhibitors) or angiotensin receptor
                  blockers, if intolerant to ACE-inhibitors are indicated for treatment left
                  ventricular dysfunction (i.e. left ventricular ejection fraction ≤40%), diabetes,
                  and proteinuric chronic kidney disease.

               -  Beta-blockers are indicated 3 years after an acute myocardial infarction, unless
                  there is persistent left ventricular dysfunction (i.e. left ventricular ejection
                  fraction ≤40%).

          4. Monitoring.

             a. Serum potassium within the last 30 days is required before initiating eplerenone.
             Repeat blood draw is required within the first week, and one month after the start of
             treatment with eplerenone.

          5. Quality of life questionnaire. a. The Kansas City Cardiomyopathy Questionnaire
             (KCCQ-12) will be administered at baseline and 8 weeks. The KCCQ-12 instrument will be
             mailed to the subject. Study coordinator will call the subject at 8 weeks to confirm
             vital status, assess if any adverse reactions from eplerenone, and provide assistance
             to completing the KCCQ-12, if needed.

Gender

All

Ages

55 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Anthony Bavry, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03923530

Organization ID

201901097

Responsible Party

Principal Investigator

Study Sponsor

North Florida Foundation for Research and Education

Collaborators

 Malcom Randall VA Medical Center

Study Sponsor

Anthony Bavry, MD, Principal Investigator, University of Florida

Verification Date

May 2020