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Completed

NCT Number: NCT01800292

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

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.

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Key information

Conditions

Hypertension, Pulmonary Artery Cardiovascular Diseases Familial Primary Pulmonary Hypertension Heart Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil

Drug

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

Primary outcomes

  1. exercise capacity not on/on sildenafil therapy

    Time frame: 3 months

    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 outcomes

  1. 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

    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 outcomes

  1. World Health Organization functional class

    Time frame: 3 months

    World Health Organization functional class (I-IV) will be determined at baseline and at 3 months

  2. BNP (brain natriuretic peptide)

    Time frame: 3 months

    Blood will be collected to get BNP (brain natriuretic peptide)lab result at baseline and at 3 months

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Acronym: LV strain

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Feb 27, 2013
Registry last updated
Nov 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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