Heart Failure, CongestivePhase 2NCT00132886
Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure
A Phase 2 study testing tolvaptan in people with Heart Failure, Congestive, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 31 sites in 2 countries.
Trial summary
This study will look at how a single dose of study medication (tolvaptan) versus an inactive sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure. Higher than normal pressures can be related to symptoms of heart failure (shortness of breath, fatigue, etc.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- tolvaptan
- How many people
- 140 participants
- Where
- 31 sitesin 2 countries
- Study dates
- Dec 2004to Dec 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Class III or IV heart failure for at least 3 months
- Left ventricular ejection fraction less than or equal to 40%
- Currently being treated for heart failure with standard therapies for at least one month
Who cannot join
- Women who are pregnant or breastfeeding
- Inability to take oral medications
- Uncontrolled hypertension, bradyarrhythmias or tachyarrhythmias
- Hypertrophic obstructive cardiomyopathy
- Severe obstructive pulmonary disease
- Significant renal impairment
- Significant uncorrected valvular or congenital heart disease
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States26 sites
ACRI
Atlanta, Georgia, 30342
Primary Cardiology Associates
Ayer, Massachusetts, 01432
UNC Heart Failure Program
Chapel Hill, North Carolina, 27517
Northwestern University
Chicago, Illinois, 60612
Robert Rush University Medical Center
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45267
Cleveland VA Medical Center
Cleveland, Ohio, 44106
Henry Ford Hospital
Detroit, Michigan, 48202
Broward General Medical Center
Fort Lauderdale, Florida, 33316
Texas Heart Institute
Houston, Texas, 77702
Oracle Research, A Div of the Heart Center
Huntsville, Alabama, 35801
University of Iowa Health Care
Iowa City, Iowa, 52242
Cardiovascular Center at Shands Jacksonville
Jacksonville, Florida, 32209
Loyola University of Chicago
Maywood, Illinois, 60153
Merced Heart Associates
Merced, California, 95340
University of Medicine and Dentistry
Newark, New Jersey, 07103
Heart Consultants, PC
Omaha, Nebraska, 68122
Southeast Texas Clinical Research
Orange, Texas, 77702
Oregon Health Sciences University
Portland, Oregon, 97239
Cardiologist Institute
Slidell, Louisiana, 70458
Medical Research Institute Louisiana Heart Hospital
Slidell, Louisiana, 70458
Washington University School of Medicine
St Louis, Missouri, 63110
Olive View-UCLA Medical Center
Sylmar, California, 91324
Guthrie Foundation
Syre, Pennsylvania, 18840
Tampa General Hospital
Tampa, Florida, 33606
U-MASS Memorial Medical Center
Worchester, Massachusetts, 01655
Romania5 sites
Spitalul Clinic Urgenta
Bucharest, 014461
Institutul de Boli Cardiovasculare
Bucharest, 022322
Institutul de Boli Cardiovasculare"Prof. Dr. C.C. Illiescu"
Bucharest, Cod 022322
Institutul Inimii
Judetul Cluj, Cod 400001
Institutul de Boli Cardiovasculare si Transplant
Judetul Mures, Cod 540136
About this study
Official title: Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Single Oral Tolvaptan Tablets on Hemodynamic Parameters in Subjects With Heart Failure
This study will look at how a single dose of study medication (tolvaptan) versus an inactive sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure. Higher than normal pressures can be related to symptoms of heart failure (shortness of breath, fatigue, etc.).
- Conditions
- Heart Failure, Congestive
- Being tested
- tolvaptan
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tolvaptanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart pressures (PCWP) at 3 to 8 hours post-dose
Secondary outcomes (5)
Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose
Change in urine output and free water clearance
Change from baseline in urine osmolality
Cmax, tmax, and AUC 12h of tolvaptan in plasma
Adverse events, vital signs and clinical labs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startDec 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Udelson, MD, Study chair, Cardiovascular Clinical Studies and Tufts/New England Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132886
- Sponsor's protocol ID
- 156-04-247
- Status last verified
- May 2012
- First submitted
- 18 Aug 2005
- Last updated
- 3 May 2012
- Results posted
- No
Publications
Hiukka A, Westerbacka J, Leinonen ES, Watanabe H, Wiklund O, Hulten LM, Salonen JT, Tuomainen TP, Yki-Jarvinen H, Keech AC, Taskinen MR. Long-term effects of fenofibrate on carotid intima-media thickness and augmentation index in subjects with type 2 diabetes mellitus. J Am Coll Cardiol. 2008 Dec 16;52(25):2190-7. doi: 10.1016/j.jacc.2008.09.049.
PubMed 19095138Udelson JE, Orlandi C, Ouyang J, Krasa H, Zimmer CA, Frivold G, Haught WH, Meymandi S, Macarie C, Raef D, Wedge P, Konstam MA, Gheorghiade M. Acute hemodynamic effects of tolvaptan, a vasopressin V2 receptor blocker, in patients with symptomatic heart failure and systolic dysfunction: an international, multicenter, randomized, placebo-controlled trial. J Am Coll Cardiol. 2008 Nov 4;52(19):1540-5. doi: 10.1016/j.jacc.2008.08.013.
PubMed 19007589
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Single Oral Tolvaptan Tablets on Hemodynamic Parameters in Subjects With Heart Failure
- ClinicalTrials.gov ID
- NCT00132886
- Acronym / sponsor ID
- 156-04-247
- Conditions
- Heart Failure, Congestive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 22 Aug 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 study will look at how a single dose of study medication (tolvaptan) versus an inactive sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure. Higher than normal pressures can be related to symptoms of heart failure (shortness of breath, fatigue, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with Class III or IV heart failure for at least 3 months
- Left ventricular ejection fraction less than or equal to 40%
- Currently being treated for heart failure with standard therapies for at least one month
Key exclusion criteria (7 listed)
- Women who are pregnant or breastfeeding
- Inability to take oral medications
- Uncontrolled hypertension, bradyarrhythmias or tachyarrhythmias
- Hypertrophic obstructive cardiomyopathy
- Severe obstructive pulmonary 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 |
|---|---|---|
| tolvaptan | Drug | – |
Primary outcome
Change in heart pressures (PCWP) at 3 to 8 hours post-dose
5 secondary outcomes
Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose
Change in urine output and free water clearance
Change from baseline in urine osmolality
Cmax, tmax, and AUC 12h of tolvaptan in plasma
Adverse events, vital signs and clinical labs
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 3 May 2012.
- Derived from this study: PubMed 19095138Hiukka A, Westerbacka J, Leinonen ES, Watanabe H, Wiklund O, Hulten LM, Salonen JT, Tuomainen TP, Yki-Jarvinen H, Keech AC, Taskinen MR. Long-term effects of fenofibrate on carotid intima-media thickness and augmentation index in subjects with type 2 diabetes mellitus. J Am Coll Cardiol. 2008 Dec 16;52(25):2190-7. doi: 10.1016/j.jacc.2008.09.049.
- Derived from this study: PubMed 19007589Udelson JE, Orlandi C, Ouyang J, Krasa H, Zimmer CA, Frivold G, Haught WH, Meymandi S, Macarie C, Raef D, Wedge P, Konstam MA, Gheorghiade M. Acute hemodynamic effects of tolvaptan, a vasopressin V2 receptor blocker, in patients with symptomatic heart failure and systolic dysfunction: an international, multicenter, randomized, placebo-controlled trial. J Am Coll Cardiol. 2008 Nov 4;52(19):1540-5. doi: 10.1016/j.jacc.2008.08.013.
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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.
James Udelson, MD study chair
Cardiovascular Clinical Studies and Tufts/New England Medical Center
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tolvaptan in people with Heart Failure, Congestive, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 31 sites in 2 countries.
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 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Romania. 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?
Change in heart pressures (PCWP) at 3 to 8 hours post-dose. 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 NCT00132886, which also lists 2 linked publications.
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 3 May 2012.