Clinical Trial: Impact of Rehabilitation Program on PAH Patients Treated With Macitentan.

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: The Impact of Macitentan Therapy and Rehabilitation Program on Peak Oxygen Consumption in Patients With Severe Pulmonary Arterial Hypertension

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Soroka University Medical Center

Current Primary Outcome: 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


Original Primary Outcome: Cardio-pulmonary exercise test [ Time Frame: 0-24 weeks ]

Physiological response to exercise


Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • Echocardiography [ 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 test [ Time Frame: 0-24 weeks ]
    Functional capacity assesment


Information By: Soroka University Medical Center

Dates:
Date Received: February 5, 2017
Date Started: April 15, 2017
Date Completion: May 1, 2018
Last Updated: April 4, 2017
Last Verified: January 2017