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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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

Other trials in Romania

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.).

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.

  1. Change in heart pressures (PCWP) at 3 to 8 hours post-dose

Secondary outcomes (5)

  1. Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose

  2. Change in urine output and free water clearance

  3. Change from baseline in urine osmolality

  4. Cmax, tmax, and AUC 12h of tolvaptan in plasma

  5. 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.

  1. First posted22 Aug 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionDec 2006
  4. Study completionDec 2006

Resources

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)
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 19095138

  • Udelson 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

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; AzTrials last refreshed its copy on 8 Nov 2026.

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