Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)

Hypertension, Pulmonary Clinical Trial

Official title:

A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191137
• Other study ID #: 17407
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2014
• Last updated: September 12, 2017
• Start date: September 23, 2014
• Est. completion date: July 16, 2016

Study information

• Verified date: September 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The MOTION study was a prospective, Phase IV study for patients with Pulmonary Arterial Hypertension (PAH). The study was designed to further explore patient-reported outcomes in PAH subjects who were not on active treatment and living in the United States. In addition, the study explored the use of new telemetric technology (Accelerator band) to evaluate if this technology correlates with improvements in 6 Minute Walking Distance 6MWD in patients with PAH.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 16, 2016
• Est. primary completion date: July 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male or female patients, 18 to 80 years of age at Visit 0

• Women of childbearing potential must have a negative pre-treatment pregnancy test, negative monthly pregnancy test, and must use reliable methods of contraception according to the Risk Evaluation Mitigation Strategies (REMS) guidance

• Symptomatic pulmonary arterial hypertension, World Health Organization Group 1 with a pulmonary vascular resistance (PVR) >300 dyn*sec*cm-5, mean pulmonary artery pressure (PAP mean) =25 mmHg, and pulmonary capillary wedge pressure (PCWP) =15 mmHg as assessed by right heart catheterization within 6 months prior to Screening (Visit 0)

• PAH of the following types:

Idiopathic (IPAH) Familial (FPAH)

Associated with PAH (APAH) due to:

Connective tissue disease Congenital heart disease, but only if patient underwent surgical repair more than one year before enrollment Anorexigen or amphetamine use Portal hypertension with liver cirrhosis

• Not treated with PAH-specific pulmonary medications within 14 days of Screening (Visit 0)

• 6MWD between 150 meters and 450 meters

Exclusion Criteria:

• Patients who are pregnant

• Patients currently on nitrate and/or nitric oxide (NO) donor therapy; patients currently taking phosphodiesterase 5 (PDE5) inhibitors (such as sildenafil, tadalafil, vardenafil) and non-specific PDE inhibitors (theophylline, dipyridamole)

• Non-WHO group 1 Pulmonary Hypertension

• Severe restrictive lung disease

• History of uncontrolled high blood pressure or hypotension

• A medical disorder, condition, or history that in the opinion of the Investigator would impair their ability to participate or complete this study

• Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary

Intervention

Drug:
• Riociguat (Adempas, BAY63-2521)
Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score	The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.	Baseline to Week 24
Secondary	Change From Baseline to Weeks 4 and 16 in the LPH Total Score	The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.	Baseline to Week 4 and Week 16
Secondary	Change From Week 16 to Week 24 in the LPH Total Score (Completers Analysis Set Only)	The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.	Week 16 to Week 24
Secondary	Change From Baseline to Weeks 4, 16, and 24 in the LPH Physical Dimension Score	The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.	Baseline to Weeks 4, 16, and 24
Secondary	Change From Week 16 to Week 24 in the LPH Physical Dimension Score (Completers Analysis Set Only)	The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.	Week 16 to Week 24
Secondary	Change From Baseline to Weeks 4, 16, and 24 in the LPH Emotional Dimension Score	The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.	Baseline to Week 4, Week 16 and Week 24
Secondary	Change From Week 16 to Week 24 in the LPH Emotional Dimension Score (Completers Analysis Set Only)	The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.	Week 16 to Week 24
Secondary	Percentage of Patients With a Minimal Clinically Significant Important Difference (MCID) From Baseline in LPH Total Score at Weeks 4, 16, and 24	For LPH total score, the MCID was an 11-point decrease from baseline. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.	Baseline to Week 4, Week 16 and Week 24
Secondary	Percentage of Patients With an MCID From Baseline in LPH Physical Dimension Score at Weeks 4, 16, and 24	For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.	Baseline to Week 4, Week 16 and Week 24
Secondary	Percentage of Patients With an MCID From Baseline in LPH Emotional Dimension Score at Weeks 4, 16, and 24	For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.	Baseline to Week 4, Week 16 and Week 24
Secondary	Percentage of Patients With an MCID From Week 16 in LPH Total Score at Week 24 (Completers Analysis Set Only)	For LPH total score, the MCID was an 11-point decrease.	Week 16 to Week 24
Secondary	Percentage of Patients With an MCID From Week 16 in Physical Dimension Score at Week 24 (Completers Analysis Set Only)	For the physical and emotional dimension scores, the MCID was a 4-point decrease.	Week 16 to Week 24
Secondary	Percentage of Patients With an MCID From Week 16 in Emotional Dimension Score at Week 24 (Completers Analysis Set Only)	For the physical and emotional dimension scores, the MCID was a 4-point decrease.	Week 16 to Week 24
Secondary	Change From Baseline to Weeks 4, 16, and 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands and Output Demands Scores	The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.	Baseline to Week 4, Week 16 and Week 24
Secondary	Change From Baseline to Weeks 4, 16, and 24 in the WLQ Percentage of Productivity Loss	The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.	Baseline to Week 4, Week 16 and Week 24
Secondary	Change From Week 16 to Week 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands, and Output Demands Scores (Completers Analysis Set Only)	The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job.	Week 16 to Week 24
Secondary	Change From Week 16 to Week 24 in the WLQ Percentage of Productivity Loss (Completers Analysis Set Only)	The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss.	Week 16 to Week 24
Secondary	Change From Baseline to Weeks 4, 16, and 24 in the Short Form-12 Health Survey (SF-12) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score	SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient's point of view. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.	Baseline to Week 4, Week 16 and Week 24
Secondary	Change From Week 16 to Week 24 in the SF-12 PCS Score and MCS Score (Completers Analysis Set Only)	SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient's point of view. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.	Week 16 to Week 24
Secondary	Change From Baseline to Weeks 4, 16, and 24 in the WHO Functional Class	Functional class was determined by the WHO classification: I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.; II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.; III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.; IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.; In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.	Baseline to Week 4, Week 16 and Week 24
Secondary	Change From Week 16 to Week 24 in the WHO Functional Class (Completers Analysis Set Only)	Functional class was determined by the WHO classification: I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.; II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.; III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.; IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.	Week 16 to Week 24
Secondary	Change From Baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale	The Modified Borg Dyspnea Scale assessed the intensity of the patient's dyspnea from 0 (best) to 10 (worst). In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.	Week 16 to Week 24
Secondary	Change From Week 16 to Week 24 in the Modified Borg Dyspnea Scale (Completers Analysis Set Only)	The Modified Borg Dyspnea Scale assessed the intensity of the patient's dyspnea from 0 (best) to 10 (worst).	Week 16 to Week 24
Secondary	Change From Baseline to Weeks 16 and 24 in the 6MWD	Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured. In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint.	Week 16 to Week 24
Secondary	Change From Week 16 to Week 24 in the 6MWD (Completers Analysis Set Only)	Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured.	Week 16 to Week 24

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