Heart Failure, CongestivePhase 2NCT00259116
A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
A Phase 2 study testing Relaxin in people with Heart Failure, Congestive, run by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies at 1 site in Germany.
Trial summary
This trial is a single center, open-label, dose-finding study of recombinant human relaxin (rhRlx) given intravenously (IV) to patients with stable, compensated CHF. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- Relaxin
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2005to not given
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients over the age of 18
- New York Heart Association (NYHA) Class II-III CHF
- Left Ventricular Ejection Fraction (LVEF) of < 35%
Who cannot join
- Acute coronary syndrome
- Acute decompensated CHF
- Hypotension
- Recent significant arrhythmia
- Recent stroke
- Significant renal or hepatic impairment
- Pregnancy or child-bearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
This trial is a single center, open-label, dose-finding study of recombinant human relaxin (rhRlx) given intravenously (IV) to patients with stable, compensated CHF.
Read the detailed description
Serial cohorts of patients with stable CHF will be enrolled upon meeting eligibility criteria. Dose escalation will be guided by hemodynamic response, safety and tolerability. The effects of rhRlx on hemodynamics will be assessed.
- Conditions
- Heart Failure, Congestive
- Being tested
- Relaxin
- Keywords
- Congestive heart failure, Relaxin, Cardiac hemodynamics
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelaxinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac hemodynamics including PCWP, CO/CI, SVR
Secondary outcomes (2)
Safety and tolerability
Tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants
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)
- Investigators
- Sam Teichman, MD, Study director, BAS Medical - Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259116
- Sponsor's protocol ID
- RLX.CHF.001
- Status last verified
- Apr 2009
- First submitted
- 28 Nov 2005
- Last updated
- 15 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00259116
- Acronym / sponsor ID
- RLX.CHF.001
- Conditions
- Heart Failure, Congestive
- Keywords
- Congestive heart failure, Relaxin, Cardiac hemodynamics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companiesIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- First posted
- 29 Nov 2005 (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.
This trial is a single center, open-label, dose-finding study of recombinant human relaxin (rhRlx) given intravenously (IV) to patients with stable, compensated CHF.
Detailed description
Serial cohorts of patients with stable CHF will be enrolled upon meeting eligibility criteria. Dose escalation will be guided by hemodynamic response, safety and tolerability. The effects of rhRlx on hemodynamics will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients over the age of 18
- New York Heart Association (NYHA) Class II-III CHF
- Left Ventricular Ejection Fraction (LVEF) of < 35%
Key exclusion criteria (7 listed)
- Acute coronary syndrome
- Acute decompensated CHF
- Hypotension
- Recent significant arrhythmia
- Recent stroke
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 |
|---|---|---|
| Relaxin | Drug | – |
Primary outcome
Cardiac hemodynamics including PCWP, CO/CI, SVR
2 secondary outcomes
Safety and tolerability
Tolerability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2009.
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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.
Sam Teichman, MD study director
BAS Medical - Sponsor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Relaxin in people with Heart Failure, Congestive, run by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies at 1 site in Germany.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 15 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 including PCWP, CO/CI, SVR. 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 15 Apr 2009.