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OpenTrials
Completed

NCT Number: NCT03077139

Cardiac Resynchronization Therapy in Pulmonary Hypertension

This study is being conducted to determine whether patients with advanced pulmonary hypertension when treated with cardiac resynchronization therapy improve hemodynamically and/or receive clinical benefit.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

About this study

This study aims to determine whether stimulating earlier activation of the failing right ventricle in pulmonary hypertension reduces the effects of interventricular dependence in human subjects, thereby improving overall cardiac function and symptoms in patients with pulmonary hypertension and right ventricle failure with NYHA Class 3-4 symptoms.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pulmonary hypertension, defined as pulmonary artery systolic pressure greater than 40 mm Hg by transthoracic echocardiogram or right heart catheterization
  • LVEF ≥ 50%
  • Baseline 6MWT distant <400 meters
  • Baseline NYHA Functional class ≥ III

Exclusion criteria

  • LVEF < 50%
  • 6MWT duration > 400 meters
  • NYHA Functional class < III
  • Left bundle branch block
  • Non-sinus rhythm
  • Severe aortic stenosis (Aortic valve area < 1 cm2)
  • Severe mitral regurgitation
  • Acute cardiac failure
  • Dependency on intravenous inotropies
  • Severe obstructive pulmonary disease
  • Hypertrophic obstructive cardiomyopathy
  • Amyloidosis
  • Dependence on pacing

Treatment and study plan

Cardiac Resynchronization Therapy (CRT)

Device

A CRT device sends small electrical impulses to both lower chambers of the heart to help them beat together in a more synchronized pattern.

Primary outcomes

  1. 15% increase in cardiac output at the optimal VV interval over baseline cardiac output

    Time frame: the procedure

    Primary Outcome

Sponsors and collaborators

Lead sponsor

Dr. Daniel P Morin, MD MPH FHRS

Other

Registry information

Acronym: CRT in PH

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2017
Registry last updated
Sep 20, 2017

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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