Investigation of Dysynchrony in Patients With Pulmonary Hypertension

NCT01571700 | Enrolling By Invitation DMC

• 1 other identifier: DS6901
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

Mechanical Dysynchrony; Electrical Dysynchrony

Outcome Measures

Primary Outcomes (1)

• Electrical or Mechanical Dysynchrony

  Open

Study Arms (2)

Study

Patients with pulmonary hypertension.

Procedure: Catheterization Pacing

Control

ASD patients or patients with normal hearts

Interventions

Catheterization Pacing PROCEDURE

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.

Study

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jeffrey Feinstein, MD, MPH

  Stan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 5, 2012
• Study Start: September 1, 2006
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)