Completed
LV strainEcho Study - Characterization of LV Strain Patterns in Patients With Mildly Elevated PCWP and Pulmonary Hypertension
What is being tested
sildenafil
Drug
Who is being recruted
Cardiovascular Diseases+7
+ Heart Diseases
+ Hypertension, Pulmonary
From 18 to 80 Years
+13 Eligibility Criteria
How is the trial designed
Diagnostic Study
Phase 4
Interventional
Study Start: February 2013
Summary
Principal SponsorUniversity of Arizona
Last updated: November 4, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2013
Actual date on which the first participant was enrolled.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.
Principal SponsorUniversity of Arizona
Last updated: November 4, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
9 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Cardiovascular DiseasesHeart DiseasesHypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesVascular DiseasesVentricular DysfunctionHypertensionVentricular Dysfunction, LeftFamilial Primary Pulmonary Hypertension
Criteria
6 inclusion criteria required to participate
6 minute walk distance > 150 meters and < 450 meters
Age > 18 and < 80
No evidence of active ischemic heart disease
Patients with New York Heart Association/World Health Organization(NYHA/WHO)functional class II-III
Show More Criteria
7 exclusion criteria prevent from participating
Contraindications to right heart catheterization
Contraindications to submaximal exercise testing
Left ventricular ejection fraction < 50%
Moderate-severe aortic and mitral valve abnormality
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalSubjects 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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Arizona Medical Center
Tucson, United StatesOpen University of Arizona Medical Center in Google MapsCompletedOne Study Center