Impact of Rehabilitation Program on PAH Patients Treated With Macitentan.

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03045666
• Other study ID #: SOR-026116-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: February 5, 2017
• Last updated: April 4, 2017
• Start date: April 15, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: January 2017
• Source: Soroka University Medical Center
• Contact: Avital Keren Abriel, MD
• Phone: 507777618
• Email: avitalab[@]bgu.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: May 1, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Soroka University Medical Center	University of Haifa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Physiological response to exercise	0-24 weeks
Secondary	Echocardiography: dimensions and pressure of left and right ventricles, cardiac output, pulmonary arterial pressure (systolic, diastolic and mean), pulmonary capillary wedge pressure	Cardiac function	0-12 weeks
Secondary	EMPHASIS10 questionnaire	Disease specific quality of life questionnaire	0-24 weeks
Secondary	SF-36 questionnaire	Quality of life questionnaire	0-24 weeks
Secondary	N-terminal prohormone brain natriuretic peptide (NT-proBNP)	high levels of NT-proBNP can indicate heart failure	0-12 weeks
Secondary	Functional class evaluation	Functional class as classified by the world health organization (WHO)	0-24 weeks
Secondary	6 minute walk distance	Functional capacity assesment by 6 minute walk test	0-24 weeks