Trial · NCT02497937
A Study to Evaluate the Effect of the Transient Receptor Potential Vanilloid 4 (TRPV4) Channel Blocker, GSK2798745, on Pulmonary Gas Transfer and Respiration in Patients With Congestive Heart Failure
NCT02497937, Phase 2, Completed, GlaxoSmithKline; results first posted 2018-09-05
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study to Evaluate the Effect of the Transient Receptor Potential Vanilloid 4 (TRPV4) Channel Blocker, GSK2798745, on Pulmonary Gas Transfer and Respiration in Patients With Congestive Heart Failure. Trials, record NCT02497937. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02497937
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effect of the Transient Receptor Potential Vanilloid 4 (TRPV4) Channel Blocker, GSK2798745, on Pulmonary Gas Transfer and Respiration in Patients With Congestive Heart Failure
- NCT number
- NCT02497937
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Heart Failure
- Interventions
- GSK2798745, Placebo
- First posted
- 2015-07-15
- Last updated
- 2018-09-05
- Results first posted
- 2018-09-05
Source ClinicalTrials.gov
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Diffusing Capacity of the Lung for Carbon Monoxide (DLco) on Pulmonary Gas Transfer (Site: Mayo) | Baseline, Day 4, Day 5 and Day 7 of each treatment period | DLco is a measure of the ability of a gas to transfer from alveoli across the alveolar epithelium and capillary endothelium to the red blood cells. Changes in DLco reflect the alveolar-capillary membrane conductance. Acute pulmonary congestion causes a reduction in DLco. In participants with heart failure, decrease in DLco serves as a predictor of disease progression. An impairment in the diffusing capacity of the lung may be related to symptoms and exercise intolerance associated with heart failure. DLco was measured just prior to and after the 3- minute step test on Days -1, and 7 and just prior to and after an intravenous saline infusion on Day 5. Day -1 was Baseline and change from Baseline was calculated from Day -1 pre-exercise of the respective period, except when calculating the post-infusion change from Baseline, where the pre-infusion value was used as Baseline. Data of DLco (milliliter per millimeter of mercury per minute \[mL/mmHg/min\]) for Mayo site is presented. |
| Primary | Change From Baseline in the Diffusing Capacity of the Lung for DLco on Pulmonary Gas Transfer (Site: Hennepin) | Baseline, Day 4, Day 5 and Day 7 of each treatment period | DLco is a measure of the ability of a gas to transfer from the alveoli across the alveolar epithelium and the capillary endothelium to the red blood cells. Changes in DLco reflect the alveolar-capillary membrane conductance. Acute pulmonary congestion cause a reduction in DLco. In participants with heart failure, decrease in DLco serves as a predictor of disease progression. An impairment in the diffusing capacity of the lung may be related to the symptoms and exercise intolerance associated with heart failure. DLco was measured just prior to and after the 3- minute step test on Days -1, and 7 and just prior to and after an intravenous saline infusion on Day 5. Day -1 was Baseline and change from Baseline was calculated from Day -1 Pre-Exercise of the respective period, except when calculating the post-infusion change from Baseline, where the pre-infusion value was used as the Baseline. Statistical analysis was not performed as the sample size was too small |
| Secondary | Change From Baseline in Diffusing Capacity of the Lung for Nitric Oxide (DLno) and Membrane Conductance (DM) | Baseline, Day 4, Day 5 and Day 7 of each treatment period | DLno is a measure of the ability of a gas to transfer from the alveoli across the alveolar epithelium and the capillary endothelium to the red blood cells. Changes in DLco reflect the alveolar-capillary DM. Since nitric oxide has a greater affinity for hemoglobin, transfer of gas mainly limits the diffusion of nitric oxide across the alveolar capillary membrane. Day -1 was Baseline and change from Baseline was calculated from Day -1 pre-exercise of the respective period, except when calculating the post-infusion change from Baseline, where the pre-infusion value was used as Baseline. The data is presented only for participants from the Mayo Clinic as the data was not collected at Hennepin. |
| Secondary | Change From Baseline in Capillary Blood Volume (Vc) | Baseline, Day 4, Day 5 and Day 7 of each treatment period | Vc is defined as volume of blood within the capillaries. Day -1 was Baseline and change from Baseline was calculated from Day -1 pre-exercise of the respective period, except when calculating the post-infusion change from Baseline, where the pre-infusion value was used as the Baseline. The data is presented only for participants from the Mayo Clinic as the data was not collected at Hennepin. |
| Secondary | Change From Baseline in DLco Following Exercise and Following an Intravenous Saline Infusion (Site: Mayo) | Baseline, Day 5 and Day 7 of each treatment period | DLco is a measure of the ability of a gas to transfer from the alveoli across the alveolar epithelium and the capillary endothelium to the red blood cells. Changes in DLco reflect the alveolar-capillary membrane conductance. Acute pulmonary congestion causes a reduction in DLco. In participants with heart failure, decrease in DLco serves as a predictor of disease progression. DLco was measured just prior to and after the 3- minute step test on Days -1, and 7 and just prior to and after an intravenous saline infusion on Day 5. Day -1 was Baseline and change from Baseline was calculated from Day -1 pre-exercise of the respective period, except when calculating the post-infusion change from Baseline, where the pre-infusion value was used as the Baseline. Data for DLco following exercise and following an intravenous saline infusion is presented for Mayo site. |
| Secondary | Change From Baseline in DLco Following Exercise and Following an Intravenous Saline Infusion (Site: Hennepin) | Baseline, Day 5 and Day 7 of each treatment period | DLco is a measure of the ability of a gas to transfer from the alveoli across the alveolar epithelium and the capillary endothelium to the red blood cells. Changes in DLco reflect the alveolar-capillary membrane conductance. Acute pulmonary congestion cause a reduction in DLco. In participants with heart failure, decrease in DLco serves as a predictor of disease progression. DLco was measured just prior to and after the 3- minute step test on Days -1, and 7 and just prior to and after an intravenous saline infusion on Day 5. Day -1 was Baseline and change from Baseline was calculated from Day -1 pre-Exercise of the respective period, except when calculating the post-infusion change from Baseline, where the pre-infusion value was used as the Baseline. Data for DLco following exercise and following an intravenous saline infusion is presented for Hennepin site is presented. |
| Secondary | Change From Baseline in the Ventilation/Volume of Carbon Dioxide Production (VE/VCO2) Ratio | Baseline and Day 7 of each treatment period | Participants were asked to participate in a submaximal exercise test that consisted of 3 parts: a 2-minute (min) resting Baseline, a 3-min step exercise and a 1-min recovery period. Throughout the test, breathing pattern, gas exchange, and heart rate were monitored using a simplified gas analysis system. Respiratory exchange ratio and the Borg Rating of Perceived Exertion measures were utilized to ensure participants perform progressive exercise while maintaining a submaximal level throughout the exercise period. Minute ventilation, breath frequency, tidal volume, oxygen consumption, carbon dioxide (CO2) production, Respiratory exchange ratio (RER) and end tidal CO2 were obtained from the breath-by-breath gas measurements. The VE/VCO2 slope and other variables were derived from this data. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from value at specified time point. |
| Secondary | Change From Baseline in Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 Second (FEV1), Forced Expiratory Flows (FEF) 25-75, FEF50 and FEF75 | Baseline, Day 4 and Day 7 of each treatment period | FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FVC is the total amount of air exhaled during the lung function test. FEF is the the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. FEF 25-75, FEF50 and FEF75 is defined as a reduction in forced expiratory flow at 25 to 75 percent of the pulmonary volume. Results presented combines data across all sites. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from value at specified time point. |
| Secondary | Change From Baseline in Functional Residual Capacity (FRC) | Baseline, Day 4 and Day 7 of each treatment period | FRC is the volume of air present in the lungs at the end of passive expiration. FRC was planned to be measured by body plethysmography. Analysis was planned but not performed. FRC parameter was not collected because other measures which were collected served as reasonable surrogates. |
| Secondary | Change From Baseline in End-expiratory Lung Volume (EELV) Measured by Body Plethysmograph | Baseline, Day 4 and Day 7 of each treatment period | EELV corresponds to FRC in the presence of positive end expiration pressure (PEEP). Analysis was planned but not performed. EELV parameter was not collected because other measures which were collected served as reasonable surrogates. |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 registered outcomesOutcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Diffusing Capacity of the Lung for Carbon Monoxide (DLco) on Pulmonary Gas Transfer (Site: Mayo) | Baseline, Day 4, Day 5 and Day 7 of each treatment period | Analysis Population comprised of participants in the 'All Subjects' population having Baseline and post-Baseline assessments of the endpoint of interest for both periods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | mL/mmHg/min | MEAN |
| PRIMARY | Change From Baseline in the Diffusing Capacity of the Lung for DLco on Pulmonary Gas Transfer (Site: Hennepin) | Baseline, Day 4, Day 5 and Day 7 of each treatment period | Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | mL/mmHg/min | MEAN |
| SECONDARY | Change From Baseline in Diffusing Capacity of the Lung for Nitric Oxide (DLno) and Membrane Conductance (DM) | Baseline, Day 4, Day 5 and Day 7 of each treatment period | Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | mL/mmHg/min | MEAN |
| SECONDARY | Change From Baseline in Capillary Blood Volume (Vc) | Baseline, Day 4, Day 5 and Day 7 of each treatment period | Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | mL | MEAN |
| SECONDARY | Change From Baseline in DLco Following Exercise and Following an Intravenous Saline Infusion (Site: Mayo) | Baseline, Day 5 and Day 7 of each treatment period | Analysis Population. | mL/mmHg/min | MEAN |
| SECONDARY | Change From Baseline in DLco Following Exercise and Following an Intravenous Saline Infusion (Site: Hennepin) | Baseline, Day 5 and Day 7 of each treatment period | Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | mL/mmHg/min | MEAN |
| SECONDARY | Change From Baseline in the Ventilation/Volume of Carbon Dioxide Production (VE/VCO2) Ratio | Baseline and Day 7 of each treatment period | Analysis Population | Ratio | MEAN |
| SECONDARY | Change From Baseline in Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 Second (FEV1), Forced Expiratory Flows (FEF) 25-75, FEF50 and FEF75 | Baseline, Day 4 and Day 7 of each treatment period | Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Liters | MEAN |
| SECONDARY | Change From Baseline in Functional Residual Capacity (FRC) | Baseline, Day 4 and Day 7 of each treatment period | Analysis Population. Analysis was planned but not performed. FRC parameter was not collected because other measures which were collected served as reasonable surrogates. | ||
| SECONDARY | Change From Baseline in End-expiratory Lung Volume (EELV) Measured by Body Plethysmograph | Baseline, Day 4 and Day 7 of each treatment period | Analysis Population. Analysis was planned but not performed. EELV parameter was not collected because other measures which were collected served as reasonable surrogates. |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 outcomesResults by group743
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Diffusing Capacity of the Lung for Carbon Monoxide (DLco) on Pulmonary Gas Transfer (Site: Mayo) | Placebo | Day -1, post exercise,n =7,7 | 0.6 | Standard Deviation 0.98 | mL/mmHg/min |
| Change From Baseline in the Diffusing Capacity of the Lung for Carbon Monoxide (DLco) on Pulmonary Gas Transfer (Site: Mayo) | GSK2798745 2.4 mg | Day -1, post exercise,n =7,7 | 1.4 | Standard Deviation 1.47 | mL/mmHg/min |
| Change From Baseline in the Diffusing Capacity of the Lung for Carbon Monoxide (DLco) on Pulmonary Gas Transfer (Site: Mayo) | Placebo | Day 4, n =6,7 | -0.4 | Standard Deviation 0.85 | mL/mmHg/min |
| Change From Baseline in the Diffusing Capacity of the Lung for Carbon Monoxide (DLco) on Pulmonary Gas Transfer (Site: Mayo) | GSK2798745 2.4 mg | Day 4, n =6,7 | 0.6 | Standard Deviation 1.16 | mL/mmHg/min |
| Change From Baseline in the Diffusing Capacity of the Lung for Carbon Monoxide (DLco) on Pulmonary Gas Transfer (Site: Mayo) | Placebo | Day 5,pre infusion,n =7,7 | -1.0 | Standard Deviation 0.94 | mL/mmHg/min |
| Change From Baseline in the Diffusing Capacity of the Lung for Carbon Monoxide (DLco) on Pulmonary Gas Transfer (Site: Mayo) | GSK2798745 2.4 mg | Day 5,pre infusion,n =7,7 | 0.4 | Standard Deviation 1.31 | mL/mmHg/min |
| Change From Baseline in the Diffusing Capacity of the Lung for Carbon Monoxide (DLco) on Pulmonary Gas Transfer (Site: Mayo) | Placebo | Day 5,post infusion,n =7,7 | -0.8 | Standard Deviation 0.65 | mL/mmHg/min |
| Change From Baseline in the Diffusing Capacity of the Lung for Carbon Monoxide (DLco) on Pulmonary Gas Transfer (Site: Mayo) | GSK2798745 2.4 mg | Day 5,post infusion,n =7,7 | -0.7 | Standard Deviation 0.81 | mL/mmHg/min |
| Change From Baseline in the Diffusing Capacity of the Lung for Carbon Monoxide (DLco) on Pulmonary Gas Transfer (Site: Mayo) | Placebo | Day 7,pre exercise,n =7,7 | -0.6 | Standard Deviation 1.63 | mL/mmHg/min |
| Change From Baseline in the Diffusing Capacity of the Lung for Carbon Monoxide (DLco) on Pulmonary Gas Transfer (Site: Mayo) | GSK2798745 2.4 mg | Day 7,pre exercise,n =7,7 | 0.7 | Standard Deviation 1.91 | mL/mmHg/min |
1 to 10 of 743Source ClinicalTrials.gov
See all 743 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (Up to 7 Days) | STARTED | Sequence A (GSK2798745 2.4 mg)/P (Placebo) | 6 | |
| Period 1 (Up to 7 Days) | STARTED | Sequence P (Placebo)/A (GSK2798745 2.4 mg) | 5 | |
| Period 1 (Up to 7 Days) | COMPLETED | Sequence A (GSK2798745 2.4 mg)/P (Placebo) | 6 | |
| Period 1 (Up to 7 Days) | COMPLETED | Sequence P (Placebo)/A (GSK2798745 2.4 mg) | 5 | |
| Period 1 (Up to 7 Days) | NOT COMPLETED | Sequence A (GSK2798745 2.4 mg)/P (Placebo) | 0 | |
| Period 1 (Up to 7 Days) | NOT COMPLETED | Sequence P (Placebo)/A (GSK2798745 2.4 mg) | 0 | |
| Washout Period (Up to 14 Days) | STARTED | Sequence A (GSK2798745 2.4 mg)/P (Placebo) | 6 | |
| Washout Period (Up to 14 Days) | STARTED | Sequence P (Placebo)/A (GSK2798745 2.4 mg) | 5 | |
| Washout Period (Up to 14 Days) | COMPLETED | Sequence A (GSK2798745 2.4 mg)/P (Placebo) | 6 | |
| Washout Period (Up to 14 Days) | COMPLETED | Sequence P (Placebo)/A (GSK2798745 2.4 mg) | 5 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 1 | 11 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | GSK2798745 2.4 mg | 1 | 11 | |
| other | Arthropathy | Musculoskeletal and connective tissue disorders | Placebo | 0 | 11 | |
| other | Arthropathy | Musculoskeletal and connective tissue disorders | GSK2798745 2.4 mg | 1 | 11 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 0 | 11 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | GSK2798745 2.4 mg | 1 | 11 | |
| other | Dizziness | Nervous system disorders | Placebo | 1 | 11 | |
| other | Dizziness | Nervous system disorders | GSK2798745 2.4 mg | 0 | 11 | |
| other | Headache | Nervous system disorders | Placebo | 1 | 11 | |
| other | Headache | Nervous system disorders | GSK2798745 2.4 mg | 0 | 11 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 11 |
| Total, all-cause mortality | GSK2798745 2.4 mg | 0 | 11 |
| Total, other adverse events | Placebo | 5 | 11 |
| Total, other adverse events | GSK2798745 2.4 mg | 7 | 11 |
| Total, serious adverse events | Placebo | 0 | 11 |
| Total, serious adverse events | GSK2798745 2.4 mg | 1 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GSK2798745 2.4 mg vs Placebo: deaths from any cause | Trial comparisons |
| GSK2798745 2.4 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02497937
GET https://conductscience.org/api/trials/v1/NCT02497937/registered?page=2