Investigation of Dysynchrony in Patients With Pulmonary Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01571700
First received: April 3, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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 Intervention
Pulmonary Hypertension
Procedure: Catheterization Pacing

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Investigation of Dysynchrony in Patients With Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Electrical or Mechanical Dysynchrony [ Time Frame: Open ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2006
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study
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.
Control
ASD patients or patients with normal hearts

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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be approached during their routine pulmonary hypertension clinic visit.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571700

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

Locations
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
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01571700     History of Changes
Other Study ID Numbers: DS6901
Study First Received: April 3, 2012
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Mechanical Dysynchrony
Electrical Dysynchrony

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

ClinicalTrials.gov processed this record on July 22, 2014