Congestive Heart Failure (CHF)Phase 2NCT00406575
Recombinant Human Relaxin for the Treatment of Decompensated CHF
A Phase 2 study testing Recombinant human relaxin (rhRlx) in people with Congestive Heart Failure (CHF), run by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies at 2 sites in Russia.
Trial summary
Two doses of relaxin will be compared to placebo for the treatment of patients with decompensated CHF Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Congestive Heart Failure (CHF)
- What is being tested?
- Recombinant human relaxin (rhRlx)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 2 sitesRussia
- Study dates
- Nov 2006to Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalization
- Decompensated chronic CHF (NYHA Class III-IV)
- LVEF < 35%
- PCWP > 22 mmHg
- CI < 2.3 L/min/m2
Who cannot join
- Acute CHF
- Acute coronary syndrome
- Hypotension or shock
- Recent stroke
- Allergy or sensitivity to test agents
- Significant confounding conditions or medications
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Russian Scientific Centre of Surgery n.a. B.V.Petrovsky of Russian Academy of Medical Sciences
Moscow, 119992
Educational Scientific Medical Center of the General Management Department of the President of Russian Federation. City Clinical Hospital №51
Moscow, 121309
About this study
Official title: A Phase II Randomized, Double Blind, Placebo-Controlled Study of Recombinant Human Relaxin in Patients With Decompensated Congestive Heart Failure
Two doses of relaxin will be compared to placebo for the treatment of patients with decompensated CHF
Read the detailed description
Pilot clinical data suggest that recombinant human relaxin may be effective in treating patients with decompensated CHF. This study will randomize patients in blinded manner to one of two doses of intravenous relaxin or placebo. Serial evaluations will include cardiac and renal function, as well as safety and tolerability.
- Conditions
- Congestive Heart Failure (CHF)
- Being tested
- Placebo, Recombinant human relaxin (rhRlx)
- Keywords
- Congestive heart failure, Relaxin, Hemodynamics, Renal function
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Diluent
Placebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication.
Recombinant human relaxin (rhRlx)Drug
Also called serelaxin, serelaxin (RLX030)
Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants receive diluent via continuous IV infusion for 48 hours. Receives: Drug: Placebo |
| Low Dose rhRlx | Experimental | Participants receive recombinant human relaxin (rhRlx) via continuous IV infusion for 48 hours at a rate of 100 µg/kg/day (corresponding to a dose of 4.2 µg/kg/hr). Receives: Drug: Recombinant human relaxin (rhRlx) |
| High Dose rhRlx | Experimental | Participants receive recombinant human relaxin (rhRlx) via continuous IV infusion for 48 hours at a rate of 500 µg/kg/day (corresponding to a dose of 21.0 µg/kg/hr). Receives: Drug: Recombinant human relaxin (rhRlx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac hemodynamics
Measured: Baseline through 27 hours post-infusion or discharge from the hospital.
Secondary outcomes (2)
Renal function
Renal function was to be assessed by evaluation of serum creatinine, creatinine clearance, BUN, uric acid, GFR, RBF, urine output, sodium clearance, and body weight.
Measured: Baseline through Day 10
Safety and Tolerability assessed by number of patients with adverse events (AEs)
Measured: Baseline through Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart Failure (CHF)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Dschietzig, MD, Principal investigator, Charite Hospital, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406575
- Sponsor's protocol ID
- RLX.CHF.002
- Status last verified
- May 2014
- First submitted
- 30 Nov 2006
- Last updated
- 7 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double Blind, Placebo-Controlled Study of Recombinant Human Relaxin in Patients With Decompensated Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00406575
- Acronym / sponsor ID
- RLX.CHF.002
- Conditions
- Congestive Heart Failure (CHF)
- Keywords
- Congestive heart failure, Relaxin, Hemodynamics, Renal function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companiesIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 4 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two doses of relaxin will be compared to placebo for the treatment of patients with decompensated CHF
Detailed description
Pilot clinical data suggest that recombinant human relaxin may be effective in treating patients with decompensated CHF. This study will randomize patients in blinded manner to one of two doses of intravenous relaxin or placebo. Serial evaluations will include cardiac and renal function, as well as safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive diluent via continuous IV infusion for 48 hours. |
| Low Dose rhRlx | Experimental | Drug: Recombinant human relaxin (rhRlx)Participants receive recombinant human relaxin (rhRlx) via continuous IV infusion for 48 hours at a rate of 100 µg/kg/day (corresponding to a dose of 4.2 µg/kg/hr). |
| High Dose rhRlx | Experimental | Drug: Recombinant human relaxin (rhRlx)Participants receive recombinant human relaxin (rhRlx) via continuous IV infusion for 48 hours at a rate of 500 µg/kg/day (corresponding to a dose of 21.0 µg/kg/hr). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospitalization
- Decompensated chronic CHF (NYHA Class III-IV)
- LVEF < 35%
- PCWP > 22 mmHg
- CI < 2.3 L/min/m2
Key exclusion criteria (6 listed)
- Acute CHF
- Acute coronary syndrome
- Hypotension or shock
- Recent stroke
- Allergy or sensitivity to test agents
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 |
|---|---|---|
| PlaceboAlso: DiluentPlacebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication. | Drug | Placebo |
| Recombinant human relaxin (rhRlx)Also: serelaxin, serelaxin (RLX030)Recombinant human relaxin (rhRlx) diluted for continuous IV infusion. | Drug | High Dose rhRlx, Low Dose rhRlx |
Primary outcome
Cardiac hemodynamics
Time frame: Baseline through 27 hours post-infusion or discharge from the hospital.
2 secondary outcomes
Renal function
Time frame: Baseline through Day 10
Safety and Tolerability assessed by number of patients with adverse events (AEs)
Time frame: Baseline through Day 30
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
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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.
Thomas Dschietzig, MD principal investigator
Charite Hospital, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant human relaxin (rhRlx) in people with Congestive Heart Failure (CHF), run by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies at 2 sites in Russia.
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 5 inclusion and 6 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 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Cardiac hemodynamics (time frame: Baseline through 27 hours post-infusion or discharge from the hospital.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2014.