Cardiac Resynchronization Therapy in Pulmonary Hypertension (CRT in PH)

September 19, 2017 updated by: Dr. Daniel P Morin, MD MPH FHRS
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
15% increase in cardiac output at the optimal VV interval over baseline cardiac output
Time Frame: the procedure
Primary Outcome
the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Daniel P Morin, MD MPH FHRS

Investigators

  • Principal Investigator: Daniel Morin, MD, Cardiac Electrophysiologist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2012

Primary Completion (Actual)

March 23, 2017

Study Completion (Actual)

March 23, 2017

Study Registration Dates

First Submitted

March 7, 2017

First Submitted That Met QC Criteria

March 9, 2017

First Posted (Actual)

March 10, 2017

Study Record Updates

Last Update Posted (Actual)

September 20, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRT in PH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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