Cardiac Resynchronization Therapy in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

— CRT in PH  

Official title:

Cardiac Resynchronization Therapy in Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077139
• Other study ID #: CRT in PH
• Status: Completed
• Phase: N/A
• First received: March 7, 2017
• Last updated: September 19, 2017
• Start date: November 29, 2012
• Est. completion date: March 23, 2017

Study information

• Verified date: September 2017
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 23, 2017
• Est. primary completion date: March 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Device:
• Cardiac Resynchronization Therapy (CRT)
A CRT device sends small electrical impulses to both lower chambers of the heart to help them beat together in a more synchronized pattern.

Locations

Country	Name	City	State
United States	Ochsner Medical Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Daniel P Morin, MD MPH FHRS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	15% increase in cardiac output at the optimal VV interval over baseline cardiac output	Primary Outcome	the procedure