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Investigation of Dysynchrony in Patients With Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT01571700
Recruitment Status : Recruiting
First Posted : April 5, 2012
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):
Jeffrey A. Feinstein, Stanford University

Brief Summary:
The purpose of the study is to determine whether patients with pulmonary hypertension (PH) have dysynchrony, and if so whether it is electrical or mechanical. Once this has been determined, during a catheterization the investigators will test if pacing the heart improves blood circulation.

Condition or disease Intervention/treatment
Pulmonary Hypertension Procedure: Catheterization Pacing

Detailed Description:
This is a two part study of ventricular dysynchrony in patients with pulmonary hypertension. The first part is an observational study, reviewing routinely obtained clinical information (such as echocardiograms) to assess whether patients with pulmonary hypertension have electrical or mechanical dysynchrony. If so, we will proceed to the second part of the study which will assess whether temporarily pacing the right ventricle, during a clinically indicated catheterization can acutely improve hemodynamics. We will also gather control data for phase 1 from clinically indicated echos and ECG's in patients with ASD's (RV volume load) and in patients who are evaluated for an innocent murmur ( Nl heart). We hope to learn whether patients with pulmonary hypertension, and compromised right ventricles have electrical and mechanical dysnchrony. If this is true, it is theoretically possible that resynchronization (pacing) of the right ventricle could improve hemodynamics, symptoms and long term outcomes.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Official Title: Investigation of Dysynchrony in Patients With Pulmonary Hypertension
Study Start Date : September 2006
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients with pulmonary hypertension.
Procedure: Catheterization Pacing
The second part of the study will include patients with pulmonary hypertension >5 who are scheduled for a cardiac catheterization for clinical reasons. We will at the conclusion of the routine catheterization, place two pacing catheters within the right atrium and right ventricle and pace the heart at a rate approximately 10% higher than sinus rhythm for 5 minutes. We will then measure dP/dT max in the ventricles, blood pressure and cardiac output using a Fick equation to assess hemodynamics. We will repeat this 3 times using different sites in the right ventricle while simultaneously obtaining echoes to assess mechanical synchrony.
ASD patients or patients with normal hearts

Primary Outcome Measures :
  1. Electrical or Mechanical Dysynchrony [ Time Frame: Open ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be approached during their routine pulmonary hypertension clinic visit.

Inclusion Criteria:

  • Pulmonary artery mean pressure at rest of 25 mm Hg
  • Controls (for phase 2) Patients undergoing transcatheter closure of secundum ASD Patients undergoing echocardiogram and ECG as part of work-up for functional murmur who have normal intracardiac anatomy

Exclusion Criteria:

  • Reversible cause of pulmonary hypertension
  • Age < 5 yrs (for phase 2)

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): NCT01571700

Contact: Jeffrey Feinstein, MD, MPH 660-723-7913 jeff.feinstein@stanford.edu

United States, California
Stanford Hospital Recruiting
Stanford, California, United States, 94305
Contact: Jeffrey Feinstein, MD, MPH    650-723-7913    jeff.feinstein@stanford.edu   
Sponsors and Collaborators
Stanford University
Principal Investigator: Jeffrey Feinstein, MD, MPH Stan

Responsible Party: Jeffrey A. Feinstein, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01571700     History of Changes
Other Study ID Numbers: DS6901
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication

Keywords provided by Jeffrey A. Feinstein, Stanford University:
Mechanical Dysynchrony
Electrical Dysynchrony

Additional relevant MeSH terms:
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases