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

Primary Purpose

Hypertension, Pulmonary Artery, Ventricular Dysfunction, Left

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
sildenafil
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension, Pulmonary Artery focused on measuring Pulmonary Artery Hypertension, pulmonary capillary wedge pressure, sildenafil, echocardiography, left ventricular longitudinal wall strain, strain rate pre and post medical therapy, speckle tracking

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arizona Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sildenafil therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 22, 2013
Last Updated
November 3, 2015
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT01800292
Brief Title
Characterization of LV Strain Patterns in Mildly Elevated PCWP and PAH.
Acronym
LV strain
Official Title
Echo Study - Characterization of LV Strain Patterns in Patients With Mildly Elevated PCWP and Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary Artery, Ventricular Dysfunction, Left
Keywords
Pulmonary Artery Hypertension, pulmonary capillary wedge pressure, sildenafil, echocardiography, left ventricular longitudinal wall strain, strain rate pre and post medical therapy, speckle tracking

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sildenafil therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
sildenafil
Other Intervention Name(s)
Revatio, compound UK-92,480, Patent 5,250,534, sildenafil citrate, NDA 22-473, C22H30N6O4S.C6H8O7, C28H38N6O11S
Intervention Description
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.
Primary Outcome Measure Information:
Title
exercise capacity not on/on sildenafil therapy
Description
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 Outcome Measure Information:
Title
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
Description
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
Other Pre-specified Outcome Measures:
Title
World Health Organization functional class
Description
World Health Organization functional class (I-IV) will be determined at baseline and at 3 months
Time Frame
3 months
Title
BNP (brain natriuretic peptide)
Description
Blood will be collected to get BNP (brain natriuretic peptide)lab result at baseline and at 3 months
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiden Abidov, MD, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

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

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