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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

Pressure Assessment to Improve Outcomes After TAVR: a Registry

Clinicaltrials.gov identifier NCT03923530

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted August 22, 2019

Study Description

Brief summary:

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:Hypertension
    Aortic Stenosis
  • Intervention/Treatment: Drug: Eplerenone
    Behavioral: Kansas City Cardiomyopathy Questionnaire
    Diagnostic Test: Serum potasium
  • Phase: Early Phase 1
Detailed Description

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 Design
  • Study Type: Interventional
  • 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) ()
  • Primary Purpose: Treatment
  • Official Title: Pressure Assessment to Improve Outcomes After TAVR: a Registry
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: May 2020
  • Estimated Study Completion Date: September 2020
Arms and interventions
Arm Intervention/treatment
Other: Eplerenone
All subjects will receive study drug daily.
Drug: Eplerenone
50mg daily

Behavioral: Kansas City Cardiomyopathy Questionnaire
administered at baseline and 8 weeks

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
Outcome Measures
  • Primary Outcome Measures: 1. 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
  • 2. 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
Eligibility Criteria
  • Ages Eligible for Study: 55 to 100 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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 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.

Contacts and Locations
Contacts

Contact: Anthony Bavry, MD 352-548-4726 anthony.bavry@va.gov

Contact: Debra Robertson, RN 352-548-7724 debra.robertson1@va.gov

Locations

United States, Florida
Malcom Randall VA Medical Center
Gainesville

Sponsors and Collaborators

North Florida Foundation for Research and Education

Malcom Randall VA Medical Center

Investigators

Principal Investigator: Anthony Bavry, MD University of Florida

More Information
  • Responsible Party: North Florida Foundation for Research and Education
  • ClinicalTrials.gov Identifier: NCT03923530 History of Changes
  • Other Study ID Numbers: 201901097
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: August 22, 2019
  • Last Verified: August 2019
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Aortic Valve Stenosis