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

NCT ID: NCT01800292

Last Updated: 2015-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

sildenafil

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

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

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Aiden Abidov

Associate Professor, Medicine and Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aiden Abidov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona Medical Center

Tucson, Arizona, United States

Countries

United States

Other Identifiers

986-12

Identifier Type: OTHER

Identifier Source: secondary_id

13-0006-01

Identifier Type: -

Identifier Source: org_study_id