Impact of Rehabilitation Program on PAH Patients Treated With Macitentan.

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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Other: Exercise program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Rehabilitation program
No Intervention: Control Group; Patients stable on Macitentan therapy that will continue to receive it, without exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
EMPHASIS10 questionnaire	Disease specific quality of life questionnaire	0-24 weeks
SF-36 questionnaire	Quality of life questionnaire	0-24 weeks
N-terminal prohormone brain natriuretic peptide (NT-proBNP)	high levels of NT-proBNP can indicate heart failure	0-12 weeks
Functional class evaluation	Functional class as classified by the world health organization (WHO)	0-24 weeks
6 minute walk distance	Functional capacity assesment by 6 minute walk test	0-24 weeks

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Collaborators: University of Haifa
• Investigators: Principal Investigator: Avital Abriel Keren, Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2017
• Primary Completion (Anticipated): February 28, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: February 5, 2017
• First Submitted That Met QC Criteria: February 5, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: SOR-026116-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No