Characterization of Left Ventricular (LV) Strain Patterns in Mildly Elevated Pulmonary Capillary Wedge Pressure (PCWP) and Pulmonary Artery Hypertension (PAH). (LV strain)
The purpose of this study is to determine if patients with pulmonary hypertension and mildly elevated heart pressure known as PCWP will exhibit different patterns on echocardiography and that these patterns will predict treatment response to sildenafil, a drug given for this condition.
Hypertension, Pulmonary Artery
Ventricular Dysfunction, Left
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Echo Study - Characterization of LV Strain Patterns in Patients With Mildly Elevated PCWP and Pulmonary Hypertension|
- exercise capacity not on/on sildenafil therapy [ Time Frame: 3 months ] [ Designated as safety issue: No ]Subjects will have 6 minute walk testing prior to sildenafil therapy and 3 months post-initiation of sildenafil therapy. Improvement in submaximal exercise capacity on sildenafil therapy is defined as ≥ 30 M increase in 6 minute walk testing.
- Echo parameters:left ventricular septal and lateral wall longitudinal strain and strain rate, RV strain and strain rate, and LV lateral wall/septal strain and strain rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]Echo parameters will be collected pre-therapy vs 3 months on sildenafil therapy. Changes in ventricular wall motion will be documented with left ventricular (LV) septal and lateral wall longitudinal strain and strain rate, right ventricular strain and strain rate, and LV lateral wall/septal strain and strain rate utilizing speckle tracking techniques values determined by 2D-Echo.
- World Health Organization functional class [ Time Frame: 3 months ] [ Designated as safety issue: No ]World Health Organization functional class (I-IV) will be determined at baseline and at 3 months
- BNP (brain natriuretic peptide) [ Time Frame: 3 months ] [ Designated as safety issue: No ]Blood will be collected to get BNP (brain natriuretic peptide)lab result at baseline and at 3 months
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: sildenafil therapy
Subjects will have 2D-Echocardiogram measuring left ventricular strain and strain rate using speckle tracking techniques, have 6 minute walk test, World Health Organization functional class (I-IV)assignment, and BNP lab result at baseline and at 3 months. Subjects will be started on sildenafil at 20 mg by mouth three times per day at the baseline visit. Each individual will serve as his/her own control.
Subjects will be started on sildenafil at 20 mg PO TID at the baseline visit. Each individual will serve as his/her own control. Subjects will be evaluated at 3 months, with participation completed at that time.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01800292
|United States, Arizona|
|University of Arizona Medical Center|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Aiden Abidov, MD, PhD||University of Arizona|