Hypertension Clinical Trial
Official title:
Pressure Assessment to Improve Outcomes After TAVR: a Registry
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04591808 -
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
|
Phase 3 | |
| Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
| Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
| Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
| Completed |
NCT03093532 -
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Completed |
NCT05529147 -
The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
|
||
| Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
| Recruiting |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
| Completed |
NCT06008015 -
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
| Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
| Recruiting |
NCT05121337 -
Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
|
N/A | |
| Withdrawn |
NCT04922424 -
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
|
Phase 1 | |
| Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
| Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
| Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
| Completed |
NCT05621694 -
Exploring Oxytocin Response to Meditative Movement
|
N/A | |
| Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
| Recruiting |
NCT05575453 -
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
|
N/A |