Effects of Cardiorespiratory Rehabilitation on the Right... | NCT03404492

Studies
Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension

NCT03404492

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Aug 29, 2023Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Pulmonary Hypertension

Interventions

Stress echocardiography

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 12, 2018Actual

Primary Completion Date

Jul 5, 2019Actual

Completion Date

Jul 5, 2020Actual

First Submitted Date

Jan 12, 2018

First Submission Date that Met QC Criteria

Jan 12, 2018

First Posted Date

Jan 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2023

Last Update Posted Date

Aug 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Clinical improvement has been demonstrated after cardiorespiratory rehabilitation in patients with pulmonary hypertension. Rehabilitation is therefore now part of the recommendations for good practice. However, no data is available to elucidate the mechanism of this improvement: an improvement in myocardial reserve or an improvement in peripheral muscular capacity? The main objective of this study is to evaluate the difference in right ventricular contractile reserve before and after cardiorespiratory rehabilitation during stress ultrasound in pulmonary hypertension in 10 patients with pulmonary hypertension.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with pulmonary hypertension	Other		Other: Stress echocardiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stress echocardiography	Other	A stress echocardiography will be performed in addition to the traditional patient care	Patients with pulmonary hypertension

Measure	Description	Time Frame
Improvement of the subpulmonary ITS at effort >20% (presence of a right ventricular contractile reserve) defined by the improvement of the ITS or integral subpulmonary time-speed)		4 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Major patients
Proven pulmonary hypertension: PAPm ≥ 25mmHg, known PH
Group 1,3,4 or 5 of the pulmonary hypertension classification
Clinical stability > 1 month clinically determined by clinician
NYHA II or III class
Signature of informed consent form following appropriate information
Patient affiliated to the Social Security System

Exclusion Criteria:

Associated left heart disease
Complex congenital heart disease
Acoustic window which does not allow the echocardiography to be performed correctly
Permanent cardiac arrhythmia
NYHA IV class and NYHA I class
Inability to perform at least a minimal effort on an ergometer
Unstabilized acute coronary syndrome
Compensatory heart failure
Disturbances of ventricular rhythm veins, may not be narrowed.
Prevalence of high-risk embolic intracardiac thrombus
Prevalence of high-risk embolic intracardiac thrombus
Preference of a medium to high abundance peericard-like thinning.
Venous thromboembolic venous thromboembolic disease (> 3 months)
Left ventricular ejector obstruction (severe and/or symptomatic)
Persons under guardianship, under curatorship, protected by law
Persons deprived of their liberty
Pregnant and parturient women
Major not able or unable to express consent
Minors
Inability to perform cardiac rehabilitation
Modynamic instability
Follow-up impossible for geographical or psychological reasons
Inadequate command of the French language

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases