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

Study Overview
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Brief Summary
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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.

Official Title
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Echo Study - Characterization of LV Strain Patterns in Patients With Mildly Elevated PCWP and Pulmonary Hypertension

Conditions
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Hypertension, Pulmonary Artery, Ventricular Dysfunction, Left

Intervention / Treatment
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* Drug: sildenafil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sildenafil therapy<br>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. | Drug: sildenafil<br>* 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.<br>* Other names: C28H38N6O11S;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sildenafil, Pulmonary Artery Hypertension, pulmonary capillary wedge pressure, echocardiography, left ventricular longitudinal wall strain, strain rate pre and post medical therapy, speckle tracking