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Ranolazine and Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT01174173
Recruitment Status : Completed
First Posted : August 3, 2010
Results First Posted : April 23, 2015
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Sanjiv Shah, Northwestern University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Angina
Pulmonary Arterial Hypertension
Intervention Drug: Ranolazine
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ranolazine
Hide Arm/Group Description

1000 mg PO BID

Ranolazine: ranolazine 1000 mg PO BID for 3 months

Period Title: Overall Study
Started 11
Completed 10
Not Completed 1
Reason Not Completed
drug-drug interaction             1
Arm/Group Title Ranolazine
Hide Arm/Group Description

1000 mg PO BID

Ranolazine: ranolazine 1000 mg PO BID for 3 months

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
We prospectively enrolled 11 patients with WHO Group 1 PAH with mean age was 48±13 years and 73% of patients were women. Nearly half of the study participants were non-white.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  90.9%
>=65 years
1
   9.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
48  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
8
  72.7%
Male
3
  27.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  45.5%
White
5
  45.5%
More than one race
0
   0.0%
Unknown or Not Reported
1
   9.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
Exercise stress echocardiography with strain  
Mean (Standard Deviation)
Unit of measure:  Ejection Fraction (%)
Number Analyzed 11 participants
63  (5)
Right heart catheterization  
Mean (Standard Deviation)
Unit of measure:  Mean pulmonary artery pressure (mm Hg)
Number Analyzed 11 participants
48  (14)
6-minute walk test  
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 11 participants
383  (60)
1.Primary Outcome
Title Improve Angina Symptoms
Hide Description Assessed as average improvement in WHO Functional Class. The WHO Functional Class score ranges from 1 to 4, with higher scores indicating more impairment
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all participants who completed as average change in WHO Functional class score from baseline to 3 months (Baseline, 3 months)
Arm/Group Title Ranolazine
Hide Arm/Group Description:

1000 mg PO BID

Ranolazine: ranolazine 1000 mg PO BID for 3 months

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.75  (0.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments A two-sided t-test was performed with p-value < 0.05 was considered statistically significant a priori.
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title 6-Minute Walk Test
Hide Description Improve Exercise Capacity measured by 6-Minute Walk Test
Time Frame 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed in all participants who completed the study and had a 6-minute walk test at baseline and at the conclusion of the study.
Arm/Group Title Ranolazine
Hide Arm/Group Description:

1000 mg PO BID

Ranolazine: ranolazine 1000 mg PO BID for 3 months

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: meters
419  (80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments A two-sided t-test was performed for change in 6-minute walk test and p-value < 0.05 was considered statistically significant a priori.
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Improve Quality of Life
Hide Description The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The scores are averaged and transformed to a range of 0-100, in which higher scores reflect better health status and was performed at the conclusion of the study.
Time Frame 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the 8 participants who completed the KCCQ questionnaire at baseline and at the conclusion of the study (month 3)
Arm/Group Title Ranolazine
Hide Arm/Group Description:

1000 mg PO BID

Ranolazine: ranolazine 1000 mg PO BID for 3 months

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: KCCQ Summary Score
Baseline 60.3  (19.7)
Month 3 64.2  (17.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments A two-sided t-test was performed for difference from baseline and 3-month KCCQ score. A p-value of <0.05 was considered statistically significant a priori.
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title RV Perfusion on Cardiac MRI
Hide Description The majority of patients did not undergo cardiac MRI because it was difficult for the patients to tolerate the imaging study. Therefore, we were not able to assess change in RV perfusion.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ranolazine 1000 mg po Bid
Hide Arm/Group Description:
MRI was not analyzable due to inability of patients to undergo MRI due to technical issues
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Absolute RV Longitudinal Strain
Hide Description Change in absolute right ventricular (RV) longitudinal strain as assessed by exercise stress echocardiography with speckle-tracking echocardiography at baseline and conclusion of the study. An increase in exercise-induced change in RV longitudinal strain between baseline to conclusion of the study is indicative of improved RV function. If absolute RV longitudinal strain increases with exercise, that is a sign that the RV is working well. If absolute RV longitudinal strain decreases with exercise, that is a sign that the RV is not working well. Therefore, between baseline and conclusion of the study, if exercise-induced change in RV strain increases that means that the RV is working better at the conclusion of the study.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all participants who completed exercise stress echocardiography at baseline and conclusion of the study (month 3)
Arm/Group Title Ranolazine
Hide Arm/Group Description:

1000 mg PO BID

Ranolazine: ranolazine 1000 mg PO BID for 3 months

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: percentage
Baseline -1.4  (0.7)
Month 3 1.0  (0.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Right Ventricular Hemodynamics
Hide Description Mean pulmonary artery pressure was assessed invasively by right heart catheterization at the conclusion of the study to estimate right ventricular hemodynamics.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all participants who completed right heart catheterization at the conclusion of the study
Arm/Group Title Ranolazine
Hide Arm/Group Description:

1000 mg PO BID

Ranolazine: ranolazine 1000 mg PO BID for 3 months

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mm Hg
48  (6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ranolazine
Hide Arm/Group Description Ranolazine: ranolazine 1000 mg PO BID for 3 months
All-Cause Mortality
Ranolazine
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Ranolazine
Affected / at Risk (%) # Events
Total   1/11 (9.09%)    
Nervous system disorders   
Inpatient hospitalization * [1]  1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
[1]
1 patient reported symptoms of dizziness, leg weakness, and hand tremors; Because of possibility of an interaction between ranolazine and darifenacin, ranolazine was discontinued, patient withdrawn from the study, and had complete resolution.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ranolazine
Affected / at Risk (%) # Events
Total   6/11 (54.55%)    
Gastrointestinal disorders   
Constipation   3/11 (27.27%)  3
nausea   2/11 (18.18%)  2
Musculoskeletal and connective tissue disorders   
Myalgias   1/11 (9.09%)  1
Indicates events were collected by systematic assessment
This study was a small pilot Interventional study to test safety and tolerability of ranolazine in 11 patients with sx WHO Group 1 PAH patients.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sanjiv J. Shah, MD
Organization: Northwestern University
Phone: 3129262926
EMail: sanjiv.shah@northwestern.edu
Layout table for additonal information
Responsible Party: Sanjiv Shah, Northwestern University
ClinicalTrials.gov Identifier: NCT01174173    
Other Study ID Numbers: STU00030314
First Submitted: July 23, 2010
First Posted: August 3, 2010
Results First Submitted: March 9, 2015
Results First Posted: April 23, 2015
Last Update Posted: May 11, 2018