Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 67 of 112 for:    EPLERENONE

Pressure Assessment to Improve Outcomes After TAVR: a Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03923530
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Malcom Randall VA Medical Center
Information provided by (Responsible Party):
Anthony A Bavry, North Florida Foundation for Research and Education

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 Intervention/treatment Phase
Hypertension Aortic Stenosis Drug: Eplerenone Behavioral: Kansas City Cardiomyopathy Questionnaire Diagnostic Test: Serum potasium 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.


Layout table for study information
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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Eplerenone
All subjects will receive study drug daily.
Drug: Eplerenone
50mg 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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years 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 < 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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Anthony Bavry, MD 352-548-4726 anthony.bavry@va.gov
Contact: Debra Robertson, RN 352-548-7724 debra.robertson1@va.gov

Locations
Layout table for location information
United States, Florida
Malcom Randall VA Medical Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Anthony Bavry, MD    352-548-4726    anthony.bavry@va.gov   
Contact: Debra Robertson, RN    352-548-7724    debra.robertson1@va.gov   
Sponsors and Collaborators
North Florida Foundation for Research and Education
Malcom Randall VA Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Anthony Bavry, MD University of Florida

Layout table for additonal information
Responsible Party: Anthony A Bavry, Director of Cardiovascular Cath Lab, 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

Layout table for additional information
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:
Layout table for MeSH terms
Eplerenone
Aortic Valve Stenosis
Cardiovascular Diseases
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents