Characterization of LV Strain Patterns in Mildly Elevated PCWP and PAH.

University of Arizona9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Hypertension, Pulmonary Artery Ventricular Dysfunction, Left

Interventions

sildenafilDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with New York Heart Association/World Health Organization(NYHA/WHO)functional class II-III * Patients with mean pulmonary artery pressure \>25 mmHg, pulmonary capillary wedge pressure \>15 mmHg ≤18, and pulmonary vascular resistance \>3 wood units * Age \>18 and \<80 * Stable on antihypertensives and diuretics\>3 months * No evidence of active ischemic heart disease * 6 minute walk distance \>150 meters and \<450 meters Exclusion Criteria: * \- Left ventricular ejection fraction \<50% * Patients with significant restrictive lung disease (FVC\<60% predicted) and/or significant obstructive lung disease (FEV1 \<55% predicted) within 1 year of enrollment * Poorly interpretable grey scale echocardiographic images * Contraindications to right heart catheterization * Nitroglycerin therapy * Moderate-severe aortic and mitral valve abnormality * Contraindications to submaximal exercise testing

Locations (1)

University of Arizona Medical Center

Tucson, Arizona, United States

Outcomes

Primary Outcomes

exercise capacity not on/on sildenafil therapy

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.

Time frame: 3 months

Secondary Outcomes

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

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.

Time frame: 3 months

Data from ClinicalTrials.gov

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