RV Systolic and Diastolic Function and Contractile Reserve Under Acute Exercise and in Response to Chronic Exercise-based Rehabilitation

NCT04188756 | Unknown

• 1 other identifier: UniGiessenReserve
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise training in Pulmonary arterial hypertension in the setting of rehabilitation leads to an enormous improvement of functional state and haemodynamics. However the underlying mechanism is still unkown. It is assumed to be relied on Right ventricular contractile reserve, but this has never been proven with goldstandard PV-loop assessment. Our aim is to evaluate the mechanism leading to the increase in functional state and to evaluate the impact of exercise (acute and chronic) on right ventricular performance

Conditions

Pulmonary Hypertension; Right Heart Failure; Heart Failure; Contractility; RV-arterial Coupling

Outcome Measures

Primary Outcomes (1)

• Primary endpoint will be the change in baseline Ees over the 15 weeks observation period

  Ees(endsystolic elastance) is a measure of coontractility

  over 15 weeks

Secondary Outcomes (8)

• Global longitudinal strain

  over 15 weeks

• PVR

  April 2020 until July 2022

• Walking distance in 6MW

  over 15 weeks

• TAPSE,

  over 15 weeks

• mPAP

  over 15 weeks

Study Arms (2)

Exercise

OTHER

Group under exercise training for 15 weeks with High intenstiy interval training under medical control

Other: Exercise

Control

NO INTERVENTION

Group with standard care according to current guidelines

Interventions

Exercise OTHER

High intensity interval training (rehabilitation) over 15 weeks. Patients will be guided by physicians for exercise training in Pulmonary hypertension

Exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent form,
• men and women\> 18 years \<75 years
• invasively confirmed chronic PH who have received complete diagnostic evaluation by specialized physicians according to at a center for pulmonary hypertension and were adjusted for 2 months under intensive medical therapy and are stable

You may not qualify if:

• Pregnancy or lactation,
• Change in medication during the last 2 months,
• Patients with signs of right heart decompensation, severe walking disturbance,
• No previous invasively confirmation of PH, acute diseases, Infections, fever,
• active myocarditis, unstable angina pectoris, exercise-induced ventricular -arrhythmias, congestive heart failure, significant heart disease, pacemakers, and -hypertrophic obstructive cardiomyopathy, or a highly reduced left ventricular function

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

University Hospital Giessen

Giessen, 35392, Germany

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Heart Failure

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will randomized for exercice (1:1). After 15 weeks the group without exercise will be offered to take part in an exercise training

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 6, 2019
• Study Start: July 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: July 1, 2024
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)