Heart FailureNCT00924014
Comparing the Effects of Conivaptan and Diuretics on Plasma Neurohormones and Renal Blood Flow in Patients With Chronic Congestive Heart Failure
A study testing Conivaptan, Furosemide and Conivaptan and furosemide in people with Heart Failure, run by Hennepin County Medical Center, Minneapolis at 1 site in United States.
Trial summary
The purpose of the study is to compare the effects of conivaptan and diuretics on renal blood flow and neurohormones. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Conivaptan, Furosemide and Conivaptan and furosemide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Mar 2010
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of chronic congestive heart failure of any etiology
- Be between 18-80 years of age
- Able to provide consent
- Have a documented left ventricular ejection fraction within the last year of < 40%
- On a stable dose (no changes within 2 weeks) of 40 mg or greater daily dose of furosemide or its equivalent
- On standard HF therapy medications (ACEI or ARB and beta-blocker unless contraindicated)
Show all 9Show fewer
- Have an estimated glomerular filtration rate (GFR) of 30 ml/minute or greater (based on the Cockcroft Gault calculation)
- Have a hemoglobin of > 10 grams/dl
- Have a negative urine pregnancy for women of childbearing years only
Who cannot join
- Acute coronary syndrome within 1 month
- Systolic blood pressure less than or equal to 90 mmHg at time of enrollment
- Poor peripheral venous access
- Severe concomitant disease which deemed by the investigator would render them unsuitable for this trial
- Allergy or contraindication to the use of iothalamate, PAH - Specifically any allergies to iodine or iodine containing products, history of asthma and hay fever which deemed by the investigator would render them unsuitable for this trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin county Medical Center
Minneapolis, Minnesota, 55404
Steven R Goldsmith, MD
About this study
Official title: Comparative Effects of Conivaptan and Loop Diuretics on Plasma Neurohormones and Systemic and Renal Hemodynamics in Subjects With Chronic Congestive Heart Failure
The purpose of the study is to compare the effects of conivaptan and diuretics on renal blood flow and neurohormones.
Read the detailed description
- To define the hemodynamic, neurohormonal and renal responses to intravenous conivaptan in patients with chronic stable heart failure (HF), and compare these responses to those after intravenous furosemide.
- To define the hemodynamic, neurohormonal and renal responses to the combination of the two drugs (conivaptan and furosemide).
- Conditions
- Heart Failure
- Being tested
- Conivaptan, Furosemide, Conivaptan and furosemide
- Keywords
- heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConivaptanDrug
Also called vaprisol
Conivaptan 20 mg IV bolus followed by a 4 hour infusion at 1.2 mg/hr
FurosemideDrug
Also called Lasix
Furosemide will be given IV at the subjects usual oral dose up to 80 mg. If the dose is 80 mg or more only 1/2 the dose will be given IV.
Conivaptan and furosemideDrug
Also called vaprisol, lasix
Furosemide bolus first; conivaptan 20 mg IV bolus/infusion at 1.2 mg/hour for a total of 4 hours
| Study group | Role | What they receive |
|---|---|---|
| Conivaptan | Active comparator | Conivaptan will be given via IV bolus Receives: Drug: Conivaptan |
| Furosemide | Active comparator | Furosemide will be given via IV bolus Receives: Drug: Furosemide |
| conivaptan and furosemide | Active comparator | on day 3 subjects will receive both study drugs Receives: Drug: Conivaptan and furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal hemodynamics renal blood flow and glomerular filtration rate
Measured: measured on days 1, 2, 3
Secondary outcomes (1)
measure plasma neurohormone levels
Measured: predose, 1 hour and 4 hours post dose measured on day 1, 2, 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hennepin County Medical Center, Minneapolis
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Investigators
- Steven R Goldsmith, MD, Study director, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924014
- Sponsor's protocol ID
- 001
- Other IDs
- IND 104, 334
- Status last verified
- Jun 2009
- First submitted
- 17 Jun 2009
- Last updated
- 18 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Goldsmith SR, Gilbertson DT, Mackedanz SA, Swan SK. Renal effects of conivaptan, furosemide, and the combination in patients with chronic heart failure. J Card Fail. 2011 Dec;17(12):982-9. doi: 10.1016/j.cardfail.2011.08.012. Epub 2011 Oct 6.
PubMed 22123359
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Conivaptan and Loop Diuretics on Plasma Neurohormones and Systemic and Renal Hemodynamics in Subjects With Chronic Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00924014
- Acronym / sponsor ID
- 001
- Conditions
- Heart Failure
- Keywords
- heart failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Hennepin County Medical Center, MinneapolisUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 18 Jun 2009 (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.
The purpose of the study is to compare the effects of conivaptan and diuretics on renal blood flow and neurohormones.
Detailed description
- To define the hemodynamic, neurohormonal and renal responses to intravenous conivaptan in patients with chronic stable heart failure (HF), and compare these responses to those after intravenous furosemide.
- To define the hemodynamic, neurohormonal and renal responses to the combination of the two drugs (conivaptan and furosemide).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conivaptan | Active comparator | Drug: ConivaptanConivaptan will be given via IV bolus |
| Furosemide | Active comparator | Drug: FurosemideFurosemide will be given via IV bolus |
| conivaptan and furosemide | Active comparator | Drug: Conivaptan and furosemideon day 3 subjects will receive both study drugs |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have a diagnosis of chronic congestive heart failure of any etiology
- Be between 18-80 years of age
- Able to provide consent
- Have a documented left ventricular ejection fraction within the last year of < 40%
- On a stable dose (no changes within 2 weeks) of 40 mg or greater daily dose of furosemide or its equivalent
Key exclusion criteria (5 listed)
- Acute coronary syndrome within 1 month
- Systolic blood pressure less than or equal to 90 mmHg at time of enrollment
- Poor peripheral venous access
- Severe concomitant disease which deemed by the investigator would render them unsuitable for this trial
- Allergy or contraindication to the use of iothalamate, PAH - Specifically any allergies to iodine or iodine containing products, history of asthma and hay fever which deemed by the investigator would render them unsuitable for this trial
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 |
|---|---|---|
| ConivaptanAlso: vaprisolConivaptan 20 mg IV bolus followed by a 4 hour infusion at 1.2 mg/hr | Drug | Conivaptan |
| FurosemideAlso: LasixFurosemide will be given IV at the subjects usual oral dose up to 80 mg. If the dose is 80 mg or more only 1/2 the dose will be given IV. | Drug | Furosemide |
| Conivaptan and furosemideAlso: vaprisol, lasixFurosemide bolus first; conivaptan 20 mg IV bolus/infusion at 1.2 mg/hour for a total of 4 hours | Drug | conivaptan and furosemide |
Primary outcome
renal hemodynamics renal blood flow and glomerular filtration rate
Time frame: measured on days 1, 2, 3
1 secondary outcome
measure plasma neurohormone levels
Time frame: predose, 1 hour and 4 hours post dose measured on day 1, 2, 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2009.
- Derived from this study: PubMed 22123359Goldsmith SR, Gilbertson DT, Mackedanz SA, Swan SK. Renal effects of conivaptan, furosemide, and the combination in patients with chronic heart failure. J Card Fail. 2011 Dec;17(12):982-9. doi: 10.1016/j.cardfail.2011.08.012. Epub 2011 Oct 6.
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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.
Steven R Goldsmith, MD study director
Hennepin County Medical Center, Minneapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conivaptan, Furosemide and Conivaptan and furosemide in people with Heart Failure, run by Hennepin County Medical Center, Minneapolis at 1 site in United States.
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 5 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: status not confirmed, as of the sponsor's last update on 18 Jun 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 United States. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shari Mackedanz, RN BSN (612-347-5195, shari.mackedanz@hcmed.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal hemodynamics renal blood flow and glomerular filtration rate (time frame: measured on days 1, 2, 3). 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 NCT00924014, which also lists 1 linked publication.
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 18 Jun 2009.