Cardiac Resynchronization Therapy in Pulmonary Hypertension (CRT in PH)

Dr. Daniel P Morin, MD MPH FHRS

Status: Completed

Conditions: Pulmonary Hypertension

Treatments: Device: Cardiac Resynchronization Therapy (CRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03077139

CRT in PH

Details and patient eligibility

About

This study is being conducted to determine whether patients with advanced pulmonary hypertension when treated with cardiac resynchronization therapy improve hemodynamically and/or receive clinical benefit.

Full description

This study aims to determine whether stimulating earlier activation of the failing right ventricle in pulmonary hypertension reduces the effects of interventricular dependence in human subjects, thereby improving overall cardiac function and symptoms in patients with pulmonary hypertension and right ventricle failure with NYHA Class 3-4 symptoms.

Enrollment: 6 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pulmonary hypertension, defined as pulmonary artery systolic pressure greater than 40 mm Hg by transthoracic echocardiogram or right heart catheterization
• LVEF ≥ 50%
• Baseline 6MWT distant <400 meters
• Baseline NYHA Functional class ≥ III

Exclusion criteria

• LVEF < 50%
• 6MWT duration > 400 meters
• NYHA Functional class < III
• Left bundle branch block
• Non-sinus rhythm
• Severe aortic stenosis (Aortic valve area < 1 cm2)
• Severe mitral regurgitation
• Acute cardiac failure
• Dependency on intravenous inotropies
• Severe obstructive pulmonary disease
• Hypertrophic obstructive cardiomyopathy
• Amyloidosis
• Dependence on pacing

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Arms

Experimental group

Description:

Pacing wires used to stimulate ventricles in a synchronous matter

Treatment:

Device: Cardiac Resynchronization Therapy (CRT)