Diastolic Heart FailurePhase 1/2NCT00309868
Study of Nesiritide in Diastolic Heart Failure.
A Phase 1/2 study testing neseritide in people with Diastolic Heart Failure, run by Massachusetts General Hospital.
Trial summary
We hypothesize that nesiritide will have favorable effect in decreasing heart filling pressures and echocardiogram studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diastolic Heart Failure
- What is being tested?
- neseritide
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Dec 2003
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated heart filling pressure. Ejection fraction >45%. Blood pressure >90. Physician feels that the patient needs intravenous medication for heart failure.
- -
Who cannot join
- Patients receiving intravenous medication. Patients with significant heart disease or who are unstable. Patients with kidney failure or severe heart valve disease.
- -
About this study
Official title: A Study of the Acute Hemodynamic and Myocardial Effects of Nesiritide in Diastolic Heart Failure.
We hypothesize that nesiritide will have favorable effect in decreasing heart filling pressures and echocardiogram studies.
Read the detailed description
In previous studies, patients with systolic heart failure were given nesiritide and had reduced heart filling pressures. The FDA has approved nesiritide for these patients.
Between one-third and one-half of patients with heart failure have diastolic heart failure. Few of these patients have been studied while receiving nesiritide.
A study is needed to test nesiritide on this specific type of heart failure.
Patients will undergo a heart catheterization and heart biopsy. Patients will then be transferred to the intensive care unit for monitoring. An echocardiogram will be obtained, followed by an infusion of nesiritide for 24 hours. At the completion of the infusion, a repeat echocardiogram will be obtained.
- Conditions
- Diastolic Heart Failure
- Being tested
- neseritide
- Keywords
- heart catheterization, echocardiogram, nesiritide
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neseritideDrug
Also called BNP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startDec 2002
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic Heart FailureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Scios, Inc.
- Responsible party
- Principal investigator, Marc Semigran, Massachusetts General Hospital
- Investigators
- Marc J S, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309868
- Sponsor's protocol ID
- 2002-p-001736
- Status last verified
- Mar 2014
- First submitted
- 30 Mar 2006
- Last updated
- 26 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Acute Hemodynamic and Myocardial Effects of Nesiritide in Diastolic Heart Failure.
- ClinicalTrials.gov ID
- NCT00309868
- Acronym / sponsor ID
- 2002-p-001736
- Conditions
- Diastolic Heart Failure
- Keywords
- heart catheterization, echocardiogram, nesiritide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Scios, Inc.
- Study start
- Dec 2002
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 3 Apr 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.
We hypothesize that nesiritide will have favorable effect in decreasing heart filling pressures and echocardiogram studies.
Detailed description
In previous studies, patients with systolic heart failure were given nesiritide and had reduced heart filling pressures. The FDA has approved nesiritide for these patients.
Between one-third and one-half of patients with heart failure have diastolic heart failure. Few of these patients have been studied while receiving nesiritide.
A study is needed to test nesiritide on this specific type of heart failure.
Patients will undergo a heart catheterization and heart biopsy. Patients will then be transferred to the intensive care unit for monitoring. An echocardiogram will be obtained, followed by an infusion of nesiritide for 24 hours. At the completion of the infusion, a repeat echocardiogram will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elevated heart filling pressure. Ejection fraction >45%. Blood pressure >90. Physician feels that the patient needs intravenous medication for heart failure.
- -
Key exclusion criteria (2 listed)
- Patients receiving intravenous medication. Patients with significant heart disease or who are unstable. Patients with kidney failure or severe heart valve disease.
- -
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 |
|---|---|---|
| neseritideAlso: BNP | Drug | – |
Primary outcome
Not reported in the source record.
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 26 Mar 2014.
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PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
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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.
Marc J S, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing neseritide in people with Diastolic Heart Failure, run by Massachusetts General Hospital.
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 2 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 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 26 Mar 2014.