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Tricuspid RegurgitationPhase 4NCT02644616

The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement

A Phase 4 study testing tolvaptan+torasemide in people with Tricuspid Regurgitation and Right Heart Failure, run by Shanghai Chest Hospital at 1 site in China.

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

The investigators research the early improvement of fluid retention and mid-term prognosis through the administration of tolvaptan for the patient with tricuspid regurgitation and right heart failure after left heart valves replacement. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tricuspid Regurgitation, Right Heart Failure
What is being tested?
tolvaptan+torasemide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteChina
Study dates
Nov 2014to Dec 2016
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with tricuspid regurgitation and right heart failure after left heart valves replacement
  • Patients who takes existing diuretic
  • The patient is willing to participate in the study

Who cannot join

  • Patients with hypersensitivity to study drug
  • Anuric patients
  • Patients with hypernatremia
  • Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant
  • Malignant tumor
  • Patients with serious hepatic disorder or Serious Renal failure
  • Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • FangYuan

    Shanghai, Shanghai Municipality

Other trials in China

About this study

The investigators research the early improvement of fluid retention and mid-term prognosis through the administration of tolvaptan for the patient with tricuspid regurgitation and right heart failure after left heart valves replacement.

Being tested
tolvaptan+torasemide, placebo+torasemide
Keywords
tolvaptan, safety and efficacy, left heart valves replacement
Medical subject headings
Tricuspid Valve Insufficiency, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tolvaptan+torasemideDrug

    tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv

  • placebo+torasemideDrug

    placebo 15mg/d po(10 days) +torasemide 20mg/d iv

Study groups in NCT02644616
Study groupRoleWhat they receive
trial group(tolvaptan group)Active comparatortrial group (tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv,n=20)
Receives: Drug: tolvaptan+torasemide
control groupPlacebo comparatorcontrol group(placebo 15mg/d po(10 days) +torasemide 20mg/d iv,n=20)
Receives: Drug: placebo+torasemide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change of all the subjects'liquid intake and output volume change after a period(10 days) of treatment

    Measured: 2015.01-2017.12

Secondary outcomes (6)

  1. A cumulative urine volume for 72 hours (all subjects)

    Measured: 2015.01-2017.12

  2. Echocardiography results VS the baseline results(all subjects)

    Measured: 2015.01-2017.12

  3. Change of right heart failure signs(all subjects)

    Measured: 2015.01-2017.12

  4. Onset of cardiovascular event (all subjects)

    Measured: 2015.01-2017.12

  5. Onset of serious adverse event(all subjects)

    Measured: 2015.01-2017.12

  6. other adverse events(all subjects)

    Measured: 2015.01-2017.12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2016 (estimated)
  2. Study startNov 2014
  3. Primary completionDec 2016
  4. Study completionDec 2016

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02644616
Sponsor's protocol ID
156-ZOC-1401
Status last verified
Dec 2016
First submitted
29 Dec 2015
Last updated
20 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Yuan F, Wu Z, Jiang L, Zhou J, Xu L, Liu H, Ma L, Zhai Z, Zhang J. Short-Term Effects of Tolvaptan in Tricuspid Insufficiency Combined with Left Heart Valve Replacement-Caused Volume-Overload Patients: Results of a Prospective Pilot Study. Am J Cardiovasc Drugs. 2019 Apr;19(2):211-218. doi: 10.1007/s40256-018-0304-1.

    PubMed 30255476

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing tolvaptan+torasemide in people with Tricuspid Regurgitation and Right Heart Failure, run by Shanghai Chest Hospital at 1 site in China.

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 20 Dec 2016. 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 China. 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 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?

The change of all the subjects'liquid intake and output volume change after a period(10 days) of treatment (time frame: 2015.01-2017.12). 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 NCT02644616, 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 20 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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