Pressure Assessment to Improve Outcomes After TAVR: a Registry
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|ClinicalTrials.gov Identifier: NCT03923530|
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : August 22, 2019
At the Malcom Randall Veterans Affairs Medical Center (MRVAMC), intra-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 registry is interested in determining 1) the tolerability of eplerenone, and 2) feasibility of administering the Kansas City Cardiomyopathy Questionnaire (KCCQ) among patients with abnormal hemodynamics after TAVR. This registry will set the stage for a pilot randomized trial to evaluate eplerenone versus placebo among patients with abnormal hemodynamics after TAVR.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Aortic Stenosis||Drug: Eplerenone Behavioral: Kansas City Cardiomyopathy Questionnaire Diagnostic Test: Serum potasium||Early Phase 1|
Our research has disclosed that patients who have abnormal 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||1) Enroll 10 subjects with hypertension and abnormal hemodynamics after TAVR.|
|Masking:||None (Open Label)|
|Official Title:||Pressure Assessment to Improve Outcomes After TAVR: a Registry|
|Actual Study Start Date :||June 3, 2019|
|Estimated Primary Completion Date :||May 15, 2020|
|Estimated Study Completion Date :||September 30, 2020|
All subjects will receive study drug daily.
Behavioral: Kansas City Cardiomyopathy Questionnaire
administered at baseline and 8 weeks
Other Name: KCCQ
Diagnostic Test: Serum potasium
within the last 30 days is required before initiating eplerenone, repeat blood draw within the first week and starting eplerenone and 4 weeks after starting eplerenone
- Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [ Time Frame: baseline ]Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Range for subscale is 0-100 and the range for the summary score is 0-100
- Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [ Time Frame: 8 weeks ]Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Range for subscale is 0-100 and the range for the summary score is 0-100
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): NCT03923530
|Contact: Anthony Bavry, MDemail@example.com|
|Contact: Debra Robertson, RNfirstname.lastname@example.org|
|United States, Florida|
|Malcom Randall VA Medical Center||Recruiting|
|Gainesville, Florida, United States, 32608|
|Contact: Anthony Bavry, MD 352-548-4726 email@example.com|
|Contact: Debra Robertson, RN 352-548-7724 firstname.lastname@example.org|
|Principal Investigator:||Anthony Bavry, MD||University of Florida|