Heart FailurePhase 4NCT00613964
The Effects of Carperitide on Short and Long-term Prognosis in Patients With Both Cardiac and Renal Failure
A Phase 4 study testing Carperitide heart failure therapy and Standard heart failure therapy in people with Heart Failure and Renal Failure, run by Nara Medical University at 1 site in Japan.
Trial summary
Carperitide (alpha-human atrial natriuretic peptide) improves systemic hemodynamics in patients with heart failure through a vasodilatory action, a natriuretic action, and inhibition of the renin-angiotensin-aldosterone system and has been widely-used in Japan. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Heart Failure, Renal Failure
- What is being tested?
- Carperitide heart failure therapy and Standard heart failure therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- May 2009to May 2013
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure of any etiology, diagnosed according to Framingham criteria
- Estimated GFR </= 60 ml/min/1.73 m2)
Who cannot join
- Severe heart failure required percutaneous cardiopulmonary bypass support (PCPS)
- End-stage renal failure on maintenance dialysis
- Severe hepatic dysfunction
- Severe anemia
- Allergic history of carperitide
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Japan1 site
First Department of Internal Medicine, Nara Medical University
Nara, 634-8522
About this study
Carperitide (alpha-human atrial natriuretic peptide) improves systemic hemodynamics in patients with heart failure through a vasodilatory action, a natriuretic action, and inhibition of the renin-angiotensin-aldosterone system and has been widely-used in Japan. However, a paucity of report is available on the effects of carperitide on short and long-term prognosis in patients with both cardiac and renal failure. The purpose of this study is to evaluate the effects of carperitide therapy on short and long-term prognosis in patients with both cardiac and renal failure, in comparison with standard therapy.
- Conditions
- Heart Failure, Renal Failure
- Being tested
- Carperitide heart failure therapy, Standard heart failure therapy
- Keywords
- Natriuretic Peptides, Heart Failure, Renal Failure
- Medical subject headings
- Heart Failure, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carperitide heart failure therapyDrug
Also called Loop-diuretics etc + HANP
carperitide(alpha-human atrial natriuretic peptide, 0.025-0.05μg/kg/min)
Standard heart failure therapyDrug
Loop diuretics, Aldosterone blockers, Beta blockers, ACE inhibitors, Angiotensin receptor blockers, Nitrates, digitalis
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | Placebo comparator | Standard heart failure therapy excluding carperitide administration Receives: Drug: Standard heart failure therapy |
| Carperitide Therapy | Active comparator | Addition of carperitide administration to standard heart failure therapy Receives: Drug: Carperitide heart failure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unexpected rehospitalization for cardiovascular events, uremic symptom, initiation of maintenance dialysis, and kidney transplantation
Measured: at 6 months and 2 years
Secondary outcomes (5)
All cause mortality
Measured: at discharge, 6 months, and 2 years
Sudden death
Measured: at discharge, 6 months, and 2 years
Cardiovascular death
Measured: at discharge, 6 months, and 2 years
Plasma B-type natriuretic peptide concentration
Measured: at discharge, 6 months, and 2 years
Estimated GFR
Measured: at discharge, 6 months, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startMay 2009
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nara Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Yoshihiko Saito, MD, PhD, Study chair, First Department of Internal Medicine, Nara Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613964
- Sponsor's protocol ID
- Cardiol001
- Status last verified
- Feb 2009
- First submitted
- 31 Jan 2008
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Carperitide on Short and Long-term Prognosis in Patients With Both Cardiac and Renal Failure
- ClinicalTrials.gov ID
- NCT00613964
- Acronym / sponsor ID
- Cardiol001
- Conditions
- Heart Failure, Renal Failure
- Keywords
- Natriuretic Peptides, Heart Failure, Renal Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nara Medical UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 13 Feb 2008 (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.
Carperitide (alpha-human atrial natriuretic peptide) improves systemic hemodynamics in patients with heart failure through a vasodilatory action, a natriuretic action, and inhibition of the renin-angiotensin-aldosterone system and has been widely-used in Japan. However, a paucity of report is available on the effects of carperitide on short and long-term prognosis in patients with both cardiac and renal failure. The purpose of this study is to evaluate the effects of carperitide therapy on short and long-term prognosis in patients with both cardiac and renal failure, in comparison with standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | Placebo comparator | Drug: Standard heart failure therapyStandard heart failure therapy excluding carperitide administration |
| Carperitide Therapy | Active comparator | Drug: Carperitide heart failure therapyAddition of carperitide administration to standard heart failure therapy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Heart failure of any etiology, diagnosed according to Framingham criteria
- Estimated GFR </= 60 ml/min/1.73 m2)
Key exclusion criteria (6 listed)
- Severe heart failure required percutaneous cardiopulmonary bypass support (PCPS)
- End-stage renal failure on maintenance dialysis
- Severe hepatic dysfunction
- Severe anemia
- Allergic history of carperitide
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 |
|---|---|---|
| Carperitide heart failure therapyAlso: Loop-diuretics etc + HANPcarperitide(alpha-human atrial natriuretic peptide, 0.025-0.05μg/kg/min) | Drug | Carperitide Therapy |
| Standard heart failure therapyLoop diuretics, Aldosterone blockers, Beta blockers, ACE inhibitors, Angiotensin receptor blockers, Nitrates, digitalis | Drug | Standard Therapy |
Primary outcome
Unexpected rehospitalization for cardiovascular events, uremic symptom, initiation of maintenance dialysis, and kidney transplantation
Time frame: at 6 months and 2 years
5 secondary outcomes
All cause mortality
Time frame: at discharge, 6 months, and 2 years
Sudden death
Time frame: at discharge, 6 months, and 2 years
Cardiovascular death
Time frame: at discharge, 6 months, and 2 years
Plasma B-type natriuretic peptide concentration
Time frame: at discharge, 6 months, and 2 years
Estimated GFR
Time frame: at discharge, 6 months, and 2 years
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 22 Jul 2011.
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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.
Yoshihiko Saito, MD, PhD study chair
First Department of Internal Medicine, Nara Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carperitide heart failure therapy and Standard heart failure therapy in people with Heart Failure and Renal Failure, run by Nara Medical University at 1 site in Japan.
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 2 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 22 Jul 2011. 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 Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Unexpected rehospitalization for cardiovascular events, uremic symptom, initiation of maintenance dialysis, and kidney transplantation (time frame: at 6 months and 2 years). 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 22 Jul 2011.