Investigation of Dysynchrony in Patients With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Investigation of Dysynchrony in Patients With Pulmonary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01571700
• Other study ID #: DS6901
• Status: Recruiting
• Start date: September 2006
• Est. completion date: December 2025

Study information

• Verified date: September 2021
• Source: Stanford University
• Contact: Jeffrey Feinstein, MD, MPH
• Phone: 660-723-7913
• Email: jeff.feinstein[@]stanford.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrical or Mechanical Dysynchrony		Open