Characterization of LV Strain Patterns in Mildly Elevated PCWP and PAH. (LV strain)
|ClinicalTrials.gov Identifier: NCT01800292|
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : November 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypertension, Pulmonary Artery Ventricular Dysfunction, Left||Drug: sildenafil||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Echo Study - Characterization of LV Strain Patterns in Patients With Mildly Elevated PCWP and Pulmonary Hypertension|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2014|
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.
- exercise capacity not on/on sildenafil therapy [ Time Frame: 3 months ]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 ]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 ]World Health Organization functional class (I-IV) will be determined at baseline and at 3 months
- BNP (brain natriuretic peptide) [ Time Frame: 3 months ]Blood will be collected to get BNP (brain natriuretic peptide)lab result at baseline and at 3 months
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800292
|United States, Arizona|
|University of Arizona Medical Center|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Aiden Abidov, MD, PhD||University of Arizona|