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 ongoing, but not recruiting participants.
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: September 8, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Hypertension, Pulmonary Artery
Ventricular Dysfunction, Left
Drug: sildenafil
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Echo Study - Characterization of LV Strain Patterns in Patients With Mildly Elevated PCWP and Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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.


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 [ 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.


Other Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • compound UK-92,480
  • Patent 5,250,534
  • sildenafil citrate
  • NDA 22-473
  • C22H30N6O4S.C6H8O7
  • C28H38N6O11S

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800292

Locations
United States, Arizona
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
University of Arizona Sarver Heart Center
Investigators
Principal Investigator: Aiden Abidov, MD, PhD University of Arizona
  More Information

No publications provided

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01800292     History of Changes
Other Study ID Numbers: 13-0006-01, 986-12
Study First Received: February 22, 2013
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Arizona:
Pulmonary Artery Hypertension
pulmonary capillary wedge pressure
sildenafil
echocardiography
left ventricular longitudinal wall strain
strain rate pre and post medical therapy
speckle tracking

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Ventricular Dysfunction
Ventricular Dysfunction, Left
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Sildenafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 20, 2014