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Enrolling by Invitation

NCT Number: NCT01571700

Investigation of Dysynchrony in Patients With Pulmonary Hypertension

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Hospital

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Electrical or Mechanical Dysynchrony

    Time frame: Open

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2006
Primary completion
2029
Study completion
2029
First posted
Apr 5, 2012
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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