Acute Heart FailurePhase 3RELAX-AHF-ASIANCT02007720
Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF
A Phase 3 study testing Serelaxin in people with Acute Heart Failure, run by Novartis Pharmaceuticals at 132 sites in 11 countries.
Trial summary
The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Serelaxin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 876 participants
- Where
- 132 sitesin 11 countries
- Study dates
- 12 Mar 2014to 16 Jun 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age, with body weight ≤160 kg
- Hospitalized for AHF; AHF is defined as including all of the following measured at any time between presentation (including the emergency department and outpatient clinic) and at the end of screening:
- Persistent dyspnea at rest or with minimal exertion at screening and at the time of randomization
- Pulmonary congestion on chest radiograph
- Brain natriuretic peptide (BNP) ≥500 pg/mL or NT-proBNP ≥2,000 pg/mL
- Systolic BP ≥125 mmHg at the start and at the end of screening
Show all 9Show fewer
- Able to be randomized within 16 hours from presentation to the hospital, including the emergency department and outpatient clinic
- Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode
- Renal impairment defined as an estimate glomerular filtration rate using the between presentation and randomization of ≥ 25 and ≤75mL/min/1.73m2, calculated using the Modification of Diet in Renal Disease formula (or modified sMDRD formula according to specific ethnic groups and local practice guidelines).
Who cannot join
- Dyspnea primarily due to non-cardiac causes
- Temperature >38.5°C (oral or equivalent), sepsis, active and clinically significant infection requiring IV anti-microbial treatment or known presence or evidence of Human Immunodeficiency Virus (HIV) infection (based on history and/or clinical findings, including laboratory results obtained during screening period).
- Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment
- Patients with systolic blood pressure >180 mmHg at the end of screening
- AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute
- Hepatic disease unrelated to Heart Failure etiology and as determined by any one of the following: AST and/or ALT values exceeding 3 X ULN and/or bilirubin > 1.5 X ULN at screening or history of hepatic encephalopathy, esophageal varices, or portacaval shunt, or a diagnosis of cirrhosis by any means, or evidence of chronic Hepatitis B (presence of hepatitis B surface antigen production: positive HBsAg), or chronic Hepatitis C infection (presence of Hepatitis C genetic replication: positive Hepatitis C viral RNA, based on history and/or clinical findings, including laboratory results obtained during screening period).
- Significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm2 or mean gradient >50 mmHg on prior or current echocardiogram), and severe mitral stenosis
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year with a life expectancy less than 1 year
Trial locations and contacts
132 sites in 11 countries.
132 sites in 11 countries
Japan52 sites
Novartis Investigative Site
Akishima, Tokyo, 196-0003
Novartis Investigative Site
Amagasaki, Hyōgo, 660 8550
Novartis Investigative Site
Chikushino-shi, Fukuka, 818-8516
Novartis Investigative Site
Chuo Ku, Tokyo, 104-8560
Novartis Investigative Site
Fukuoka, Fukuoka, 810-0001
Novartis Investigative Site
Fukuoka, Fukuoka, 811-0213
Novartis Investigative Site
Fukuoka, Fukuoka, 815-8588
Novartis Investigative Site
Hachiōji, Tokyo, 192-0918
Novartis Investigative Site
Hamamatsu, Shizuoka, 430-8558
Novartis Investigative Site
Iizuka, Fukuoka, 820-8505
Novartis Investigative Site
Kakegawa, Shizuoka, 436-8555
Novartis Investigative Site
Kamogawa, Chiba, 2968602
Novartis Investigative Site
Kan’onjichō, Kagawa-ken, 769-1695
Novartis Investigative Site
Kanazawa, Ishikawa-ken, 920 8650
Novartis Investigative Site
Kawaguchi, Saitama, 333-0842
Novartis Investigative Site
Kawasaki, Kanagawa, 211-8533
Novartis Investigative Site
Kobe, Hyōgo, 654-0155
Novartis Investigative Site
Kochi, Kochi, 781 8555
Novartis Investigative Site
Kumamoto, Kumamoto, 861-4193
Novartis Investigative Site
Kurume, Fukuoka, 830-8543
Novartis Investigative Site
Kurume, Fukuoka, 830-8577
Novartis Investigative Site
Kusatsu, Shiga, 525 8585
Novartis Investigative Site
Kushiro, Hokkaido, 085-0062
Novartis Investigative Site
Kyoto, Kyoto, 607-8062
Novartis Investigative Site
Mito, Ibaraki, 311-4198
Novartis Investigative Site
Musashino, Tokyo, 180-8610
Novartis Investigative Site
Nagakute, Aichi-ken, 480-1195
Novartis Investigative Site
Nakano, Nagano, 383-8505
Novartis Investigative Site
Niigata, Niigata, 950-1197
Novartis Investigative Site
Ōgaki, Gifu, 503-8502
Novartis Investigative Site
Osaka, Osaka, 540-0006
Novartis Investigative Site
Osaka, 534-0021
Novartis Investigative Site
Saijō, Ehime, 793-0027
Novartis Investigative Site
Saitama, 330 8503
Novartis Investigative Site
Saku, Nagano, 3850051
Novartis Investigative Site
Sapporo, Hokkaido, 006-8555
Novartis Investigative Site
Sayama, Saitama, 350-1323
Novartis Investigative Site
Sendai, Miyagi, 981-3133
Novartis Investigative Site
Seto, Aichi-ken, 489-8642
Novartis Investigative Site
Shinagawa Ku, Tokyo, 141 8625
Novartis Investigative Site
Shinagawa-ku, Tokyo, 142-8666
Novartis Investigative Site
tabashi City, Tokyo, 173-8610
Novartis Investigative Site
Takamatsu, Kagawa-ken, 760 8557
Novartis Investigative Site
Tanabe, Wakayama, 646-8558
Novartis Investigative Site
Ueda, Nagano, 386-8610
Novartis Investigative Site
Uji, Kyoto, 611-0042
Novartis Investigative Site
Wako, Saitama, 351-0102
Novartis Investigative Site
Yatsushiro, Kumamoto, 866-8660
Novartis Investigative Site
Yokohama, Kanagawa, 227-8501
Novartis Investigative Site
Yokohama, Kanagawa, 231-8682
Novartis Investigative Site
Yokohama, Kanagawa, 232 0024
Novartis Investigative Site
Yokohama, Kanagawa, 236 0051
China18 sites
Novartis Investigative Site
Beijing, Beijing Municipality, 100037
Novartis Investigative Site
Beijing, Beijing Municipality, 100039
Novartis Investigative Site
Beijing, 100050
Novartis Investigative Site
Chongqing, 400037
Novartis Investigative Site
Guangzhou, Guangdong, 51000
Novartis Investigative Site
Guangzhou, Guangdong, 510515
Novartis Investigative Site
Hangzhou, Zhejiang, 310013
Novartis Investigative Site
Jinshan, Shanghai Municipality, 201508
Novartis Investigative Site
Lanzhou, Gansu, 730030
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200032
Novartis Investigative Site
Shanghai
Novartis Investigative Site
Shenyang, Liaoning, 110000
Novartis Investigative Site
Shenyang, Liaoning, 110003
Novartis Investigative Site
Suzhou, Jiangsu, 215006
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300121
Novartis Investigative Site
Wenzhou, Zhejiang, 325000
Novartis Investigative Site
Xian, Shanxi, 710061
Novartis Investigative Site
Yangzhou, Jiangsu
South Korea14 sites
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620
Novartis Investigative Site
Busan, 602739
Novartis Investigative Site
Cheongju-si, North Chungcheong, 28644
Novartis Investigative Site
Gwangju, 61469
Novartis Investigative Site
Gyeonggi-do, Bucheon Si, 422-711
Novartis Investigative Site
Incheon, 405 760
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Korea, 06351
Novartis Investigative Site
Seoul, Korea, 08308
Novartis Investigative Site
Seoul, Seocho Gu, 06591
Novartis Investigative Site
Seoul, 02841
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Wŏnju, Gangwon-do, 26427
Taiwan10 sites
Novartis Investigative Site
Changhua, 50006
Novartis Investigative Site
Kaohsiung City, 80756
Novartis Investigative Site
Kaohsiung City, 83301
Novartis Investigative Site
New Taipei City, 22060
Novartis Investigative Site
Taichung, 40447
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taipei, 10449
Novartis Investigative Site
Taipei, 11217
Novartis Investigative Site
Taoyuan, 33305
Novartis Investigative Site
Yilan, 26058
India8 sites
Novartis Investigative Site
Ahmedabad, Gujarat, 380054
Novartis Investigative Site
Chennai, Tamil Nadu, 600101
Novartis Investigative Site
Hyderabad, Telangana, 500082
Novartis Investigative Site
Nagpur, Maharashtra, 440010
Novartis Investigative Site
Nagpur, Maharashtra, 440012
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110029
Novartis Investigative Site
Rajasthan, India, 334003
Novartis Investigative Site
Vadodara, Gujarat, 390022
Philippines8 sites
Novartis Investigative Site
Makati City, 1229
Novartis Investigative Site
Manila, National Capital Region, 1000
Novartis Investigative Site
Manila, 1003
Novartis Investigative Site
Pasig, 1605
Novartis Investigative Site
Quezon City, Manila, 1100
Novartis Investigative Site
Quezon City, 1102
Novartis Investigative Site
Quezon City, 1113
Novartis Investigative Site
San Juan City, 1500
Malaysia7 sites
Novartis Investigative Site
Kota Kinabalu, Sabah, 88300
Novartis Investigative Site
Kuala Lumpur, MYS, 56000
Novartis Investigative Site
Kuala Lumpur, Selangor, 43000
Novartis Investigative Site
Kuala Lumpur, 50400
Novartis Investigative Site
Kuala Lumpur, 59100
Novartis Investigative Site
Kuching, Sarawak, 94300
Novartis Investigative Site
Sungai Buloh, Selangor, 47000
Thailand6 sites
Novartis Investigative Site
Bangkok, 10330
Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Chiang Mai, 50200
Novartis Investigative Site
Muang, 40002
Novartis Investigative Site
Songkhla, Hat Yai, 90110
Lebanon4 sites
Novartis Investigative Site
Beirut, 1107 2020
Novartis Investigative Site
Beirut
Novartis Investigative Site
El Achrafiyé, 166830
Novartis Investigative Site
Hazmiyeh, 470
Jordan3 sites
Novartis Investigative Site
Amman, JOR, 11152
Novartis Investigative Site
Amman, 11183
Novartis Investigative Site
Amman, 11184
Singapore2 sites
Novartis Investigative Site
Singapore, 117549
Novartis Investigative Site
Singapore, 169609
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo Controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients
The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.
- Conditions
- Acute Heart Failure
- Being tested
- Serelaxin, Placebo, Standard of CareTherapy
- Keywords
- Serelaxin,, WHF,, Likert Scale,, RELAX-AHF-ASIA,, RLX030,, AHF,, acute heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerelaxinDrug
Intravenous infusion
PlaceboDrug
Intravenous infusion
Standard of CareTherapyOther
This treatment can include but is not limited to intravenous and/or oral diuretics, ACE inhibitors/angiotensin receptor antagonists, β blockers, and aldosterone receptor antagonists, etc.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients will receive continuous intravenous infusion of matching placebo serelaxin for 48 hours. Receives: Drug: Placebo; Other: Standard of CareTherapy |
| Serelaxin | Experimental | Patients will receive continuous intravenous infusion of serelaxin(30 µg/kg/day) for 48 hours. Receives: Drug: Serelaxin; Other: Standard of CareTherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With a Clinical Composite Endpoint of Treatment Success, Treatment Failure, or no Change.
The trichotomous clinical composite endpoint of treatment success, treatment failure, or no change. Treatment success defined as improvement of dyspnea by Likert scale and at least 2 points improvement by at least 2 physician assessed signs and symptoms (orthopnea, rales edema, and jugular venous pulse) at Day 2; treatment failure defined as worsening heart failure, death, or re-hospitalization due to heart failure or renal failure through Day 5; no change defined as neither the criteria for treatment success nor the criteria for treatment failure was met through Day 5.
Measured: through day 5
Secondary outcomes (13)
Time to WHF
Results are given in terms of number of participants with at least one worsening heart failure (WHF) event through day 5 (pre-defined timeframe).
Measured: Through Day 5
Time to CV Death
analysis of time to CEC CV death through day 180 : results are given in terms of number of participants with CV death event through day 180 (pre-defined timeframe).
Measured: Through Day 180
Time to All-cause Death
Results are given in terms of number of participants with all cause death event through day 180 (pre-defined timeframe).
Measured: Through Day 180
Time to Moderate or Marked Improvements in Dyspnea by Likert Scale, Expressed in Days
Time to event is computed as the number of days from randomization to moderate or marked improvements in dyspnea by Likert scale
Measured: Through Day 5
Dyspnea by VAS-AUC Changes
Change from baseline in Dyspena by VAS-AUC through Day 5, expressed in mm-hours
Measured: Through Day 5
Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization
Length of stay will be defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day
Measured: Up to day 30
Renal Dysfunction and Prevention of Worsening of Renal Function
number of participants with renal dysfunction or in-hospital worsening of renal function through Day 5
Measured: Through Day 5
Time to Re-hospitalization Due to Heart Failure and Renal Impairment
Time to event is computed as the number of days from randomization to re-hospitalization due to Heart Failure and renal impairment
Measured: Through Day 180
Time to CV Death or Re-hospitalization Due to Heart Failure/ Renal Failure
Results are given in terms of number of participants with CV death or at least one re-hospitalization due to Heart Failure through day 180 (pre-defined timeframe).
Measured: Through Day 180
Time to In-hospital Worsening Heart Failure Through Day 5
Results are given in terms of number of participants with at least one in-hospital worsening heart failure through day 5 (pre-defined timeframe). In-hospital worsening heart failure is defined by symptoms only, signs only, and both symptoms and signs.
Measured: Through Day 5
Use of Loop Diuretic and Vasoactive Agents
Number of patients reported with use of loop diuretic and vasoactive agents from randomization through Day 5
Measured: Through Day 5
Change From Baseline in Cardio-renal Biomarkers
Measured: Day 2 and Day 5
Number of Patients Reported With Total Adverse Events, Serious Adverse Events and Death.
To evaluate the safety and tolerability of intravenous serelaxin in AHF patients, number of patients with total adverse events, serious adverse events and death will be analyzed.
Measured: For the safety evaluation, all adverse events will be collected from signing of the informed consent form through Day 5 for non-serious AEs and through Day 14 for serious AEs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study start12 Mar 2014
- Primary completion27 Mar 2017
- Study completion16 Jun 2017
Why it stopped: Study was terminated based on results from pivotal adult AHF study CRLX030A2301
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 876 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007720
- Sponsor's protocol ID
- CRLX030A2302
- Acronym
- RELAX-AHF-ASIA
- Status last verified
- Jun 2019
- First submitted
- 20 Nov 2013
- Last updated
- 2 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Publications
Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.
PubMed 35184572Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.
PubMed 34514815
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo Controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients
- ClinicalTrials.gov ID
- NCT02007720
- Acronym / sponsor ID
- RELAX-AHF-ASIA / CRLX030A2302
- Conditions
- Acute Heart Failure
- Keywords
- Serelaxin,, WHF,, Likert Scale,, RELAX-AHF-ASIA,, RLX030,, AHF,, acute heart failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated based on results from pivotal adult AHF study CRLX030A2301
- Enrolment
- 876 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2014 (actual)
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Posted 2 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Other: Standard of CareTherapyPatients will receive continuous intravenous infusion of matching placebo serelaxin for 48 hours. |
| Serelaxin | Experimental | Drug: Serelaxin, Other: Standard of CareTherapyPatients will receive continuous intravenous infusion of serelaxin(30 µg/kg/day) for 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female ≥ 18 years of age, with body weight ≤160 kg
- Hospitalized for AHF; AHF is defined as including all of the following measured at any time between presentation (including the emergency department and outpatient clinic) and at the end of screening:
- Systolic BP ≥125 mmHg at the start and at the end of screening
- Able to be randomized within 16 hours from presentation to the hospital, including the emergency department and outpatient clinic
- Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode
Key exclusion criteria (8 listed)
- Dyspnea primarily due to non-cardiac causes
- Temperature >38.5°C (oral or equivalent), sepsis, active and clinically significant infection requiring IV anti-microbial treatment or known presence or evidence of Human Immunodeficiency Virus (HIV) infection (based on history and/or clinical findings, including laboratory results obtained during screening period).
- Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment
- Patients with systolic blood pressure >180 mmHg at the end of screening
- AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SerelaxinIntravenous infusion | Drug | Serelaxin |
| PlaceboIntravenous infusion | Drug | Placebo |
| Standard of CareTherapyThis treatment can include but is not limited to intravenous and/or oral diuretics, ACE inhibitors/angiotensin receptor antagonists, β blockers, and aldosterone receptor antagonists, etc. | Other | Placebo, Serelaxin |
Primary outcome
Percentage of Patients With a Clinical Composite Endpoint of Treatment Success, Treatment Failure, or no Change.
Time frame: through day 5
The trichotomous clinical composite endpoint of treatment success, treatment failure, or no change. Treatment success defined as improvement of dyspnea by Likert scale and at least 2 points improvement by at least 2 physician assessed signs and symptoms (orthopnea, rales edema, and jugular venous pulse) at Day 2; treatment failure defined as worsening heart failure, death, or re-hospitalization due to heart failure or renal failure through Day 5; no change defined as neither the criteria for treatment success nor the criteria for treatment failure was met through Day 5.
13 secondary outcomes
Time to WHF
Time frame: Through Day 5
Time to CV Death
Time frame: Through Day 180
Time to All-cause Death
Time frame: Through Day 180
Time to Moderate or Marked Improvements in Dyspnea by Likert Scale, Expressed in Days
Time frame: Through Day 5
Dyspnea by VAS-AUC Changes
Time frame: Through Day 5
Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization
Time frame: Up to day 30
Renal Dysfunction and Prevention of Worsening of Renal Function
Time frame: Through Day 5
Time to Re-hospitalization Due to Heart Failure and Renal Impairment
Time frame: Through Day 180
Time to CV Death or Re-hospitalization Due to Heart Failure/ Renal Failure
Time frame: Through Day 180
Time to In-hospital Worsening Heart Failure Through Day 5
Time frame: Through Day 5
Use of Loop Diuretic and Vasoactive Agents
Time frame: Through Day 5
Change From Baseline in Cardio-renal Biomarkers
Time frame: Day 2 and Day 5
Number of Patients Reported With Total Adverse Events, Serious Adverse Events and Death.
Time frame: For the safety evaluation, all adverse events will be collected from signing of the informed consent form through Day 5 for non-serious AEs and through Day 14 for serious AEs.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35184572Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.
- Derived from this study: PubMed 34514815Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
132 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Serelaxin in people with Acute Heart Failure, run by Novartis Pharmaceuticals at 132 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 132 sites in Japan, China, South Korea, Taiwan, India and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With a Clinical Composite Endpoint of Treatment Success, Treatment Failure, or no Change. (time frame: through day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02007720, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.