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Completed

NCT Number: NCT02976324

The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale

This study evaluates the effect of external diaphragmatic pacemaker on the patients with chronic cor pulmonale. Half of participants will receive external diaphragmatic pacemaker, while the other half will receive routine therapy.

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Key information

Conditions

Chronic Cor Pulmonale Cardiovascular Diseases Heart Diseases Pulmonary Heart Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

About this study

Investigate the effect of external diaphragmatic pacemaker on chronic cor pulmonale, the indicators include: respiratory muscle force, diaphragmatic degree of excursion and thickness, pulmonary artery pressure, respiratory distress, feeling of fatigue and quality of life, pulmonary function,NT-proBNP,PaO2 and PaCO2.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of chronic cor pulmonale and admit to hospital

Exclusion criteria

  • pneumothorax or mediastinal emphysema
  • active tuberculosis
  • install a cardiac pacemaker
  • acute cardiocerebrovascular events: acute myocardial infarction, acute myocarditis, severe arrhythmia, severe cerebrovascular accidents.
  • pregnancies
  • end-stage patients (expected survival time less than 6 months)

Treatment and study plan

external diaphragmatic pacemaker group

Device

9 counts per minute, with stimulate frequency 40 Hz

Primary outcomes

  1. cardiopulmonary function

    Time frame: 10 days

    six miunte walk test

Secondary outcomes

  1. MIP

    Time frame: 10 DAYS

    MAX INSPIRATORY PRESSURE

Sponsors and collaborators

Lead sponsor

Zhang Xiangyu

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2016
Registry last updated
Oct 23, 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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