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

University of Arizona

Status and phase: Completed; Phase 4

Conditions: Ventricular Dysfunction, Left; Hypertension, Pulmonary Artery

Treatments: Drug: sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT01800292

13-0006-01

986-12 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

sildenafil therapy

Experimental group

Description:

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.

Treatment:

Drug: sildenafil