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

Ventricular Dysfunction, Left Clinical Trial

— LV strain  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800292
• Other study ID #: 13-0006-01
• Secondary ID: 986-12
• Status: Completed
• Phase: Phase 4
• First received: February 22, 2013
• Last updated: November 3, 2015
• Start date: February 2013
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Hypertension, Pulmonary Artery
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

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.

Locations

Country	Name	City	State
United States	University of Arizona Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	World Health Organization functional class	World Health Organization functional class (I-IV) will be determined at baseline and at 3 months	3 months	No
Other	BNP (brain natriuretic peptide)	Blood will be collected to get BNP (brain natriuretic peptide)lab result at baseline and at 3 months	3 months	No
Primary	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	No
Secondary	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	No