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Cardiac Resynchronization Therapy in Pulmonary Hypertension (CRT in PH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 7, 2017
First Posted Date  ICMJE March 10, 2017
Last Update Posted Date September 20, 2017
Actual Study Start Date  ICMJE November 29, 2012
Actual Primary Completion Date March 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
15% increase in cardiac output at the optimal VV interval over baseline cardiac output [ Time Frame: the procedure ]
Primary Outcome
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03077139 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiac Resynchronization Therapy in Pulmonary Hypertension
Official Title  ICMJE Cardiac Resynchronization Therapy in Pulmonary Hypertension
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Hypertension
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Arms
Pacing wires used to stimulate ventricles in a synchronous matter
Intervention: Device: Cardiac Resynchronization Therapy (CRT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2017)
6
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2017)
10
Actual Study Completion Date  ICMJE March 23, 2017
Actual Primary Completion Date March 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03077139
Other Study ID Numbers  ICMJE CRT in PH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dr. Daniel P Morin, MD MPH FHRS, Ochsner Health System
Study Sponsor  ICMJE Dr. Daniel P Morin, MD MPH FHRS
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Morin, MD Cardiac Electrophysiologist
PRS Account Ochsner Health System
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP