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

NCT01800292 | Completed Phase 4

• 2 other identifiers: 13-0006-01986-12
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Pulmonary Artery; Ventricular Dysfunction, Left

Keywords

Pulmonary Artery Hypertension; pulmonary capillary wedge pressure; sildenafil; echocardiography; left ventricular longitudinal wall strain; strain rate pre and post medical therapy; speckle tracking

Outcome Measures

Primary Outcomes (1)

• exercise capacity not on/on sildenafil therapy

  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.

  3 months

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

  3 months

Other Outcomes (2)

• World Health Organization functional class

  3 months

• BNP (brain natriuretic peptide)

  3 months

Study Arms (1)

sildenafil therapy

EXPERIMENTAL

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

Interventions

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.

Also known as: Revatio, compound UK-92,480, Patent 5,250,534, sildenafil citrate, NDA 22-473, C22H30N6O4S.C6H8O7, C28H38N6O11S

sildenafil therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• minute walk distance \>150 meters and \<450 meters

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Hypertension; Ventricular Dysfunction, Left; Familial Primary Pulmonary Hypertension

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Aiden Abidov, MD, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Medicine and Radiology

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: February 27, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: November 4, 2015

Record last verified: 2015-11

Locations

US (1)