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OpenTrials
Completed

NCT Number: NCT02644616

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

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.

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Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Failure Heart Valve Diseases Right Heart Failure Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

FangYuan

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

tolvaptan+torasemide

Drug

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

placebo+torasemide

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 2015.01-2017.12

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

    Time frame: 2015.01-2017.12

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

    Time frame: 2015.01-2017.12

  4. Onset of cardiovascular event (all subjects)

    Time frame: 2015.01-2017.12

  5. Onset of serious adverse event(all subjects)

    Time frame: 2015.01-2017.12

  6. other adverse events(all subjects)

    Time frame: 2015.01-2017.12

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2016
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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