Trial · NCT01640964
An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension
NCT01640964, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2016-01-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension. Trials, record NCT01640964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01640964
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension
- NCT number
- NCT01640964
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Compensated Cirrhosis and Portal Hypertension
- Interventions
- Terlipressin acetate, Serelaxin (RLX030)
- First posted
- 2012-07-16
- Last updated
- 2016-03-15
- Other registries' IDs
- eudract:2012-000236-26
- Results first posted
- 2016-01-20
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only)) | Baseline, 120 min post serelaxin infusion | The flow is the average flow over the cardiac cycle. Total renal artery flow = left renal artery flow + right renal artery flow. These measurements were collected through magnetic resonance angiography (MRA) scans. Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment) |
| Primary | Change From Baseline of the Portal Pressure Gradient (PPG) (Study Part B) | Baseline, 120 min post-infusion start | Direct venous pressure was measured by portal pressure gradient (PPG). PPG = portal vein pressure (PVP) - inferior vena cava pressure (IVCP). Baseline blood flow for PPG was measured at pre-dose (Day 1, 0 min post-treatment). PVP was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion). |
| Secondary | Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Terlipressin Acetate Group Only)) | Baseline, 120 min post infusion | The flow is the average flow over the cardiac cycle. Total renal artery flow = left renal artery flow + right renal artery flow. These measurements were collected through magnetic resonance angiography (MRA) scans. Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment) |
| Secondary | Change From Baseline of the Blood Flow for the Hepatic Artery (Study Part A (Serelaxin Treatment Group Only)) | Baseline, 120 min post-infusion | A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as hepatic artery. The flow is the average flow over the cardiac cycle. Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment). |
| Secondary | Change From Baseline of the Blood Flow for the Superior Mesenteric Artery (Study Part A (Serelaxin Treatment Group Only)) | Baseline, 120 min post-infusion | A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as superior mesenteric artery. The flow is the average flow over the cardiac cycle. Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment). |
| Secondary | Change From Baseline of the Blood Flow for the Descending Thoracic Aorta (Study Part A (Serelaxin Treatment Group Only)) | Baseline, 120 min post-infusion | A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as descending thoracic aorta. The flow is the average flow over the cardiac cycle. Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment). |
| Secondary | Change From Baseline of the Blood Flow for the Portal Vein (Study Part A (Serelaxin Treatment Group Only)) | Baseline, 120 min post-infusion | A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as the portal vein. The flow is the average flow over the cardiac cycle. Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment). |
| Secondary | Change From Baseline of the Portal Vein Pressure (PVP) (Study Part B) | Baseline, 120 min post infusion | Portal vein pressure was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion). |
| Secondary | Number of Patients With Total Adverse Events, Serious Adverse and Death as Assessment of Safety and Tolerability of Serelaxin | 4 weeks | This endpoint reports patients with any adverse event, serious adverse event and death for the serelaxin group of Part A and Part B of the study. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only)) | Baseline, 120 min post serelaxin infusion | Full analysis set (FAS) included all patients who received any amount of study treatment during the treatment period and had at least one post-Baseline assessment during that period. | L/min | MEAN |
| PRIMARY | Change From Baseline of the Portal Pressure Gradient (PPG) (Study Part B) | Baseline, 120 min post-infusion start | For Part B of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period.Only patients with a value at both baseline and this time point are included. | mmHg | MEAN |
| SECONDARY | Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Terlipressin Acetate Group Only)) | Baseline, 120 min post infusion | Full analysis set (FAS) included all patients who received any amount of study treatment during the treatment period and had at least one post-Baseline assessment during that period. | L/min | MEAN |
| SECONDARY | Change From Baseline of the Blood Flow for the Hepatic Artery (Study Part A (Serelaxin Treatment Group Only)) | Baseline, 120 min post-infusion | For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included | L/min | MEAN |
| SECONDARY | Change From Baseline of the Blood Flow for the Superior Mesenteric Artery (Study Part A (Serelaxin Treatment Group Only)) | Baseline, 120 min post-infusion | For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included | L/min | MEAN |
| SECONDARY | Change From Baseline of the Blood Flow for the Descending Thoracic Aorta (Study Part A (Serelaxin Treatment Group Only)) | Baseline, 120 min post-infusion | For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included | L/min | MEAN |
| SECONDARY | Change From Baseline of the Blood Flow for the Portal Vein (Study Part A (Serelaxin Treatment Group Only)) | Baseline, 120 min post-infusion | For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included | L/min | MEAN |
| SECONDARY | Change From Baseline of the Portal Vein Pressure (PVP) (Study Part B) | Baseline, 120 min post infusion | For Part B of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and this time point are included. | mmHg | MEAN |
| SECONDARY | Number of Patients With Total Adverse Events, Serious Adverse and Death as Assessment of Safety and Tolerability of Serelaxin | 4 weeks | Safety assessment happened on full analysis set which included all patients who received any amount of study treatment during the treatment period and had at least one post-Baseline assessment during that period. | Patients | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only)) | Part A: Serelaxin (RLX030) | 0.438 | 95% Confidence Interval 0.274 to 0.601 | L/min | |
| Change From Baseline of the Portal Pressure Gradient (PPG) (Study Part B) | Part B: Serelaxin (RLX030) | -1.2 | 95% Confidence Interval -6.1 to 3.7 | mmHg | |
| Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Terlipressin Acetate Group Only)) | Part A: Terlipressin Acetate | 0.059 | 95% Confidence Interval -0.045 to 0.164 | L/min | |
| Change From Baseline of the Blood Flow for the Hepatic Artery (Study Part A (Serelaxin Treatment Group Only)) | Part A: Serelaxin (RLX030) | 0.084 | 95% Confidence Interval -0.020 to 0.187 | L/min | |
| Change From Baseline of the Blood Flow for the Superior Mesenteric Artery (Study Part A (Serelaxin Treatment Group Only)) | Part A: Serelaxin (RLX030) | 0.002 | 95% Confidence Interval -0.087 to 0.090 | L/min | |
| Change From Baseline of the Blood Flow for the Descending Thoracic Aorta (Study Part A (Serelaxin Treatment Group Only)) | Part A: Serelaxin (RLX030) | 0.293 | 95% Confidence Interval 0.059 to 0.527 | L/min | |
| Change From Baseline of the Blood Flow for the Portal Vein (Study Part A (Serelaxin Treatment Group Only)) | Part A: Serelaxin (RLX030) | -0.091 | 95% Confidence Interval -0.204 to 0.023 | L/min | |
| Change From Baseline of the Portal Vein Pressure (PVP) (Study Part B) | Part B: Serelaxin (RLX030) | -3.7 | 95% Confidence Interval -8.8 to 1.4 | mmHg | |
| Number of Patients With Total Adverse Events, Serious Adverse and Death as Assessment of Safety and Tolerability of Serelaxin | Part A: Serelaxin (RLX030) | Any adverse event | 3 | Patients | |
| Number of Patients With Total Adverse Events, Serious Adverse and Death as Assessment of Safety and Tolerability of Serelaxin | Part B: Serelaxin (RLX030) | Any adverse event | 3 | Patients |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Terlipressin Acetate | 20 | |
| Overall Study | STARTED | Part A: Serelaxin (RLX030) | 20 | |
| Overall Study | STARTED | Part B: Serelaxin (RLX030) | 6 | |
| Overall Study | COMPLETED | Part A: Terlipressin Acetate | 19 | |
| Overall Study | COMPLETED | Part A: Serelaxin (RLX030) | 19 | |
| Overall Study | COMPLETED | Part B: Serelaxin (RLX030) | 3 | |
| Overall Study | NOT COMPLETED | Part A: Terlipressin Acetate | 1 | |
| Overall Study | NOT COMPLETED | Part A: Serelaxin (RLX030) | 1 | |
| Overall Study | NOT COMPLETED | Part B: Serelaxin (RLX030) | 3 |
Source ClinicalTrials.gov
Adverse events54
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 | Abdominal pain | Gastrointestinal disorders | Part A: Serelaxin (RLX030) | 0 | 20 | |
| other | Abdominal pain | Gastrointestinal disorders | Part A: Terlipressin Acetate | 4 | 20 | |
| other | Abdominal pain | Gastrointestinal disorders | Part B: Serelaxin (RLX030) | 0 | 6 | |
| other | Diarrhoea | Gastrointestinal disorders | Part A: Serelaxin (RLX030) | 0 | 20 | |
| other | Diarrhoea | Gastrointestinal disorders | Part A: Terlipressin Acetate | 6 | 20 | |
| other | Diarrhoea | Gastrointestinal disorders | Part B: Serelaxin (RLX030) | 0 | 6 | |
| other | Vomiting | Gastrointestinal disorders | Part A: Serelaxin (RLX030) | 0 | 20 | |
| other | Vomiting | Gastrointestinal disorders | Part A: Terlipressin Acetate | 1 | 20 | |
| other | Vomiting | Gastrointestinal disorders | Part B: Serelaxin (RLX030) | 0 | 6 | |
| other | Cellulitis | Infections and infestations | Part A: Serelaxin (RLX030) | 1 | 20 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Serelaxin (RLX030) | ||
| Total, all-cause mortality | Part A: Terlipressin Acetate | ||
| Total, all-cause mortality | Part B: Serelaxin (RLX030) | ||
| Total, other adverse events | Part A: Serelaxin (RLX030) | 2 | 20 |
| Total, other adverse events | Part A: Terlipressin Acetate | 11 | 20 |
| Total, other adverse events | Part B: Serelaxin (RLX030) | 2 | 6 |
| Total, serious adverse events | Part A: Serelaxin (RLX030) | 1 | 20 |
| Total, serious adverse events | Part A: Terlipressin Acetate | 1 | 20 |
| Total, serious adverse events | Part B: Serelaxin (RLX030) | 2 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28245243 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT01640964
GET https://conductscience.org/api/trials/v1/NCT01640964/events?page=2