Hypertension, Pulmonary Artery, Ventricular Dysfunction, Left
Conditions
Keywords
Pulmonary Artery Hypertension, pulmonary capillary wedge pressure, sildenafil, echocardiography, left ventricular longitudinal wall strain, strain rate pre and post medical therapy, speckle tracking
Brief 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.
Interventions
DRUGsildenafil
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.
Sponsors
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| exercise capacity not on/on sildenafil therapy | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization functional class | 3 months | World Health Organization functional class (I-IV) will be determined at baseline and at 3 months |
| BNP (brain natriuretic peptide) | 3 months | Blood will be collected to get BNP (brain natriuretic peptide)lab result at baseline and at 3 months |
Countries
United States
Outcome results
None listed