Characterization of Left Ventricular (LV) Strain Patterns in Mildly Elevated Pulmonary Capillary Wedge Pressure (PCWP) and Pulmonary Artery Hypertension (PAH). (LV strain)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Arizona Sarver Heart Center
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT01800292
First received: February 22, 2013
Last updated: August 29, 2013
Last verified: August 2013

February 22, 2013
August 29, 2013
February 2013
October 2013   (final data collection date for primary outcome measure)
exercise capacity not on/on sildenafil therapy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01800292 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
Same as current
  • World Health Organization functional class [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    World Health Organization functional class (I-IV) will be determined at baseline and at 3 months
  • BNP (brain natriuretic peptide) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Blood will be collected to get BNP (brain natriuretic peptide)lab result at baseline and at 3 months
Same as current
 
Characterization of Left Ventricular (LV) Strain Patterns in Mildly Elevated Pulmonary Capillary Wedge Pressure (PCWP) and Pulmonary Artery Hypertension (PAH).
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Hypertension, Pulmonary Artery
  • Ventricular Dysfunction, Left
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
  • compound UK-92,480
  • Patent 5,250,534
  • sildenafil citrate
  • NDA 22-473
  • C22H30N6O4S.C6H8O7
  • C28H38N6O11S
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.
Intervention: Drug: sildenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
30
February 2014
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01800292
13-0006-01, 986-12
No
University of Arizona
University of Arizona
University of Arizona Sarver Heart Center
Principal Investigator: Aiden Abidov, MD, PhD University of Arizona
University of Arizona
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP