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

Phase 4

Completed

• Conditions: Ventricular Dysfunction, Left; Hypertension, Pulmonary Artery
• Interventions: Drug: sildenafil

• Registration Number: NCT01800292
• Lead Sponsor: University of Arizona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-02-25
• Study First Posted: 2013-02-27
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-03
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sildenafil therapy	sildenafil	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.

Primary Outcome Measures

Name	Time	Method
exercise capacity not on/on sildenafil therapy	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

University of Arizona Medical Center; 🇺🇸 Tucson, Arizona, United States