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Cardiac Resynchronization Therapy in Pulmonary Hypertension (CRT in PH)

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ClinicalTrials.gov Identifier: NCT03077139
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Daniel P Morin, MD MPH FHRS, Ochsner Health System

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Device: Cardiac Resynchronization Therapy (CRT) Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiac Resynchronization Therapy in Pulmonary Hypertension
Actual Study Start Date : November 29, 2012
Actual Primary Completion Date : March 23, 2017
Actual Study Completion Date : March 23, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arms
Pacing wires used to stimulate ventricles in a synchronous matter
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 15% increase in cardiac output at the optimal VV interval over baseline cardiac output [ Time Frame: the procedure ]
    Primary Outcome


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077139


Locations
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United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Dr. Daniel P Morin, MD MPH FHRS
Investigators
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Principal Investigator: Daniel Morin, MD Cardiac Electrophysiologist
More Information
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Responsible Party: Dr. Daniel P Morin, MD MPH FHRS, Cardiac Electrophysiologist, Ochsner Health System
ClinicalTrials.gov Identifier: NCT03077139     History of Changes
Other Study ID Numbers: CRT in PH
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases