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Cardiac Resynchronization Therapy in Pulmonary Hypertension (CRT in PH)

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac Resynchronization Therapy (CRT)
Sponsored by
Dr. Daniel P Morin, MD MPH FHRS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ochsner Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arms

Arm Description

Pacing wires used to stimulate ventricles in a synchronous matter

Outcomes

Primary Outcome Measures

15% increase in cardiac output at the optimal VV interval over baseline cardiac output
Primary Outcome

Secondary Outcome Measures

Full Information

First Posted
March 7, 2017
Last Updated
September 19, 2017
Sponsor
Dr. Daniel P Morin, MD MPH FHRS
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1. Study Identification

Unique Protocol Identification Number
NCT03077139
Brief Title
Cardiac Resynchronization Therapy in Pulmonary Hypertension
Acronym
CRT in PH
Official Title
Cardiac Resynchronization Therapy in Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 29, 2012 (Actual)
Primary Completion Date
March 23, 2017 (Actual)
Study Completion Date
March 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Daniel P Morin, MD MPH FHRS

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arms
Arm Type
Experimental
Arm Description
Pacing wires used to stimulate ventricles in a synchronous matter
Intervention Type
Device
Intervention Name(s)
Cardiac Resynchronization Therapy (CRT)
Intervention Description
A CRT device sends small electrical impulses to both lower chambers of the heart to help them beat together in a more synchronized pattern.
Primary Outcome Measure Information:
Title
15% increase in cardiac output at the optimal VV interval over baseline cardiac output
Description
Primary Outcome
Time Frame
the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Morin, MD
Organizational Affiliation
Cardiac Electrophysiologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Cardiac Resynchronization Therapy in Pulmonary Hypertension

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