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Impact of Rehabilitation Program on PAH Patients Treated With Macitentan.

This study is not yet open for participant recruitment.
Verified January 2017 by Soroka University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03045666
First Posted: February 7, 2017
Last Update Posted: April 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Haifa
Information provided by (Responsible Party):
Soroka University Medical Center
  Purpose
48 patients, over the age of 18, with pulmonary arterial hypertension (PAH) classified as WHO III-IV, that are all stable under Macitentan therapy ( medication for treating PAH patients), will be recruited to the study through the pulmonary hypertension (PH) clinic at Soroka Medical Center. The patients will be randomly divided into an intervention group, which will exercise twice a week for 12 weeks, supervised by physiotherapists, and a control group, which will only receive the medication. Tests will be performed before the beginning of the intervention program, 6 weeks after it has begun, at the end of the 12 week program, and 3 months after finishing the program.

Condition Intervention
Pulmonary Arterial Hypertension Other: Exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Impact of Macitentan Therapy and Rehabilitation Program on Peak Oxygen Consumption in Patients With Severe Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Cardio-pulmonary exercise test- measurements of VO2 , anaerobic threshold, respiratory exchange ratio, O2 pulse, ventilatory reserve, heart rate, End tidal CO2 and O2, work rate, ventilation (VE), VCO2 during exercise test [ Time Frame: 0-24 weeks ]
    Physiological response to exercise


Secondary Outcome Measures:
  • Echocardiography: dimensions and pressure of left and right ventricles, cardiac output, pulmonary arterial pressure (systolic, diastolic and mean), pulmonary capillary wedge pressure [ Time Frame: 0-12 weeks ]
    Cardiac function

  • EMPHASIS10 questionnaire [ Time Frame: 0-24 weeks ]
    Disease specific quality of life questionnaire

  • SF-36 questionnaire [ Time Frame: 0-24 weeks ]
    Quality of life questionnaire

  • N-terminal prohormone brain natriuretic peptide (NT-proBNP) [ Time Frame: 0-12 weeks ]
    high levels of NT-proBNP can indicate heart failure

  • Functional class evaluation [ Time Frame: 0-24 weeks ]
    Functional class as classified by the world health organization (WHO)

  • 6 minute walk distance [ Time Frame: 0-24 weeks ]
    Functional capacity assesment by 6 minute walk test


Estimated Enrollment: 48
Anticipated Study Start Date: April 15, 2017
Estimated Study Completion Date: May 1, 2018
Estimated Primary Completion Date: February 28, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group
Patients stable on Macitentan therapy will exercise twice a week for 12 weeks, supervised by physiotherapists. The exercise program includes aerobic and strength exercises, at 2-3 minutes intervals.
Other: Exercise program
patients who are stable on Macitentan therapy (received in both groups before enrollment) and will exercise at a pulmonary rehabilitation program twice a week for 12 weeks
Other Name: Rehabilitation program
No Intervention: Control Group
Patients stable on Macitentan therapy that will continue to receive it, without exercise.

Detailed Description:

48 patients, over the age of 18, with PAH classified as WHO III-IV, that are all stable under Macitentan therapy, will be recruited to the study through the PH clinic at Soroka Medical Center. The patients will be randomly divided into intervention and control groups.

The intervention group will exercise in a pulmonary rehabilitation program twice a week, for 12 weeks. The exercise protocol will include circuit training, with 2-3 minutes exercise intervals, including aerobic and strength training, and will be supervised by physiotherapists. The control group will continue to receive their usual Macitentan treatment.

All study participants will undergo tests before the beginning of the intervention program, 6 weeks after it has begun, at the end of the 12 week program, and 3 months after finishing the program. The tests will include a cardio-pulmonary exercise test, 6 minute walk distance measurement, WHO functional class evaluation, levels of Brain natriuretic peptide (BNP), EMPHASIS10 questionnaire (emPHasis-10 questionnaire is a short questionnaire for assessing Health Related Quality of Life in pulmonary arterial hypertension), Short Form-36 (SF-36) quality of life questionnaire and echocardiography.

Once data collection is completed, two way ANOVA repeated measures will be used to assess the changes in outcome measures.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. PAH patients group 1
  2. Patients Age > 18 years,
  3. Patients with WHO III
  4. Patients on Macitentan treatment who are stable on disease-targeted medication for at least 2 months prior to inclusion.

Exclusion Criteria:

  1. Patients with other significant comorbidity such as Pulmonary veno-occlusive disease (PVOD) or pulmonary capillary haemangiomatosis, Malignancy, Recent myocardial infarction in the last 2 weeks.
  2. Patients on other PAH specific medications treatment.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045666


Contacts
Contact: Avital Keren Abriel, MD 507777618 ext 972 avitalab@bgu.ac.il
Contact: Efrat Landau, BPT +972545899819 efratlan@gmail.com

Sponsors and Collaborators
Soroka University Medical Center
University of Haifa
Investigators
Principal Investigator: Avital Abriel Keren Soroka University Medical Center
  More Information

Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT03045666     History of Changes
Other Study ID Numbers: SOR-026116-CTIL
First Submitted: February 5, 2017
First Posted: February 7, 2017
Last Update Posted: April 6, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Macitentan
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists