Trial · NCT01870778
Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF
NCT01870778, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2018-03-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF. Trials, record NCT01870778. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01870778
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF
- NCT number
- NCT01870778
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 6,600 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Acute Heart Failure
- Interventions
- RLX030, Placebo
- First posted
- 2013-06-06
- Last updated
- 2018-03-30
- Other registries' IDs
- eudract:2013-001498-25
- Results first posted
- 2018-03-30
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Confirmed Cardiovascular (CV) Death Through Day 180 | 180 days | The percentage of participants with an adjudicated CV death through day 180 was assessed. |
| Primary | Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5 | Day 5 | The percentage of participants with WHF through day 5 was assessed. |
| Secondary | Percentage of Participants With All-cause Death Through Day 180 | 180 days | The percentage of participants with all-cause death through day 180 was assessed. |
| Secondary | Length of Total Hospital Stay (LOS) During the Index Acute Heart Failure (AHF) Hospitalization | 180 days (Participants still in the hospital at Day 60 were censored at Day 60) | Length of stay was defined as the index hospitalization discharge date and time minus the baseline date and time plus 1 day. |
| Secondary | Percentage of Participants With First Occurrence of Adjudicated CV Death or Adjudicated Re-hospitalization | 180 days | The percentage of participants with adjudicated CV death or adjudicated re-hospitalization through day 180 was assessed. |
| Secondary | Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization | 180 days (Patients still in the hospital at Day 60 were censored at Day 60) | Length of stay was defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day. |
| Secondary | Percentage of Participants With First Improvement Since Baseline in Congestive Signs and Symptoms of Heart Failure | From baseline to Day 5 | The percentage of participants with first improvement since baseline in congestive signs and symptoms was assessed. The signs and symptoms included exertional dyspnea, orthopnea, rales, jugular venous pressure and peripheral edema/pre-sacral edema. |
| Secondary | Change From Baseline in hsTroponin T Biomarker | Baseline, Day 2, Day 5 and Day 14 | Blood samples were collected to assess the change from baseline in hsTroponin T. The geometric least square mean (LSM) of the ratio of the post-baseline value to the baseline value is presented. |
| Secondary | Change From Baseline in NT-proBNP Biomarker | Baseline, Day 2, Day 5 and Day 14 | Blood samples were collected to assess the change from baseline in NT-proBNP. The ratio of the post-baseline value to the baseline value is presented. |
| Secondary | Change From Baseline in Cystatin C Biomarker | Baseline, Day 2, Day 5 and Day 14 | Blood samples were collected to assess the change from baseline in Cystatin C. The ratio of the post-baseline value to the baseline value is presented. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Confirmed Cardiovascular (CV) Death Through Day 180 | 180 days | The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5 | Day 5 | The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With All-cause Death Through Day 180 | 180 days | The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Length of Total Hospital Stay (LOS) During the Index Acute Heart Failure (AHF) Hospitalization | 180 days (Participants still in the hospital at Day 60 were censored at Day 60) | The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed. | days | MEAN |
| SECONDARY | Percentage of Participants With First Occurrence of Adjudicated CV Death or Adjudicated Re-hospitalization | 180 days | The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization | 180 days (Patients still in the hospital at Day 60 were censored at Day 60) | The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed. | days | MEAN |
| SECONDARY | Percentage of Participants With First Improvement Since Baseline in Congestive Signs and Symptoms of Heart Failure | From baseline to Day 5 | The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was considered for the analysis. For each symptom, only participants with observed baseline signs and symptoms and non-missing baseline and post baseline signs and symptoms were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in hsTroponin T Biomarker | Baseline, Day 2, Day 5 and Day 14 | Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point. | ug/L | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in NT-proBNP Biomarker | Baseline, Day 2, Day 5 and Day 14 | Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point. | pg/mL | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Cystatin C Biomarker | Baseline, Day 2, Day 5 and Day 14 | Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point. | mg/L | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Confirmed Cardiovascular (CV) Death Through Day 180 | Serelaxin (RLX030) | 8.7 | Percentage of participants | ||
| Percentage of Participants With Confirmed Cardiovascular (CV) Death Through Day 180 | Placebo | 8.9 | Percentage of participants | ||
| Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5 | Serelaxin (RLX030) | 6.9 | Percentage of participants | ||
| Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5 | Placebo | 7.7 | Percentage of participants | ||
| Percentage of Participants With All-cause Death Through Day 180 | Serelaxin (RLX030) | 11.2 | Percentage of participants | ||
| Percentage of Participants With All-cause Death Through Day 180 | Placebo | 11.9 | Percentage of participants | ||
| Length of Total Hospital Stay (LOS) During the Index Acute Heart Failure (AHF) Hospitalization | Serelaxin (RLX030) | 9.362 | Standard Deviation 9.3581 | days | |
| Length of Total Hospital Stay (LOS) During the Index Acute Heart Failure (AHF) Hospitalization | Placebo | 9.545 | Standard Deviation 9.6739 | days | |
| Percentage of Participants With First Occurrence of Adjudicated CV Death or Adjudicated Re-hospitalization | Serelaxin (RLX030) | 24.3 | Percentage of participants | ||
| Percentage of Participants With First Occurrence of Adjudicated CV Death or Adjudicated Re-hospitalization | Placebo | 24.9 | Percentage of participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Serelaxin (RLX030) | 3,274 | |
| Overall Study | STARTED | Placebo | 3,271 | |
| Overall Study | Safety Set | Serelaxin (RLX030) | 3,257 | |
| Overall Study | Safety Set | Placebo | 3,248 | |
| Overall Study | Full Analysis Set | Serelaxin (RLX030) | 3,274 | |
| Overall Study | Full Analysis Set | Placebo | 3,271 | |
| Overall Study | Biomarker Analysis Set | Serelaxin (RLX030) | 521 | |
| Overall Study | Biomarker Analysis Set | Placebo | 510 | |
| Overall Study | COMPLETED | Serelaxin (RLX030) | 3,266 | |
| Overall Study | COMPLETED | Placebo | 3,262 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events746
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 | Anaemia | Blood and lymphatic system disorders | Serelaxin (RLX030) | 48 | 3,257 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 47 | 3,248 | |
| other | Angina pectoris | Cardiac disorders | Serelaxin (RLX030) | 17 | 3,257 | |
| other | Angina pectoris | Cardiac disorders | Placebo | 15 | 3,248 | |
| other | Aortic valve incompetence | Cardiac disorders | Serelaxin (RLX030) | 21 | 3,257 | |
| other | Aortic valve incompetence | Cardiac disorders | Placebo | 25 | 3,248 | |
| other | Aortic valve stenosis | Cardiac disorders | Serelaxin (RLX030) | 23 | 3,257 | |
| other | Aortic valve stenosis | Cardiac disorders | Placebo | 13 | 3,248 | |
| other | Atrial fibrillation | Cardiac disorders | Serelaxin (RLX030) | 46 | 3,257 | |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 45 | 3,248 |
1 to 10 of 746Source ClinicalTrials.gov
See all 746 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Serelaxin (RLX030) | 363 | 3,257 |
| Total, all-cause mortality | Placebo | 386 | 3,248 |
| Total, other adverse events | Serelaxin (RLX030) | 1,336 | 3,257 |
| Total, other adverse events | Placebo | 1,277 | 3,248 |
| Total, serious adverse events | Serelaxin (RLX030) | 412 | 3,257 |
| Total, serious adverse events | Placebo | 424 | 3,248 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Serelaxin (RLX030) vs Placebo: deaths from any cause | Trial comparisons |
| Serelaxin (RLX030) 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.
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/NCT01870778
GET https://conductscience.org/api/trials/v1/NCT01870778/results?page=2