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

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

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 Overview

• Status: Completed
• Conditions: Ventricular Dysfunction, Left; Hypertension, Pulmonary Artery
• Intervention / Treatment: Drug: sildenafil

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Drug: sildenafil; 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.; Other Names: Revatio; sildenafil citrate; compound UK-92,480; Patent 5,250,534; NDA 22-473; C22H30N6O4S.C6H8O7; C28H38N6O11S

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization functional class	World Health Organization functional class (I-IV) will be determined at baseline and at 3 months	3 months
BNP (brain natriuretic peptide)	Blood will be collected to get BNP (brain natriuretic peptide)lab result at baseline and at 3 months	3 months

Collaborators and Investigators

• Sponsor: University of Arizona

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 22, 2013
• First Submitted That Met QC Criteria: February 25, 2013
• First Posted (Estimate): February 27, 2013

Study Record Updates

• Last Update Posted (Estimate): November 4, 2015
• Last Update Submitted That Met QC Criteria: November 3, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: echocardiography; sildenafil; speckle tracking; Pulmonary Artery Hypertension; pulmonary capillary wedge pressure; left ventricular longitudinal wall strain; strain rate pre and post medical therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Hypertension; Hypertension, Pulmonary; Sprains and Strains; Ventricular Dysfunction; Ventricular Dysfunction, Left; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: 13-0006-01; 986-12 (Other Identifier: University Medical Center Site Review Authority)