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

NCT02644616 | Completed Phase 4

• 1 other identifier: 156-ZOC-1401
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tricuspid Regurgitation; Right Heart Failure

Keywords

tolvaptan; safety and efficacy; left heart valves replacement

Outcome Measures

Primary Outcomes (1)

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

  2015.01-2017.12

Secondary Outcomes (6)

• A cumulative urine volume for 72 hours (all subjects)

  2015.01-2017.12

• Echocardiography results VS the baseline results(all subjects)

  2015.01-2017.12

• Change of right heart failure signs(all subjects)

  2015.01-2017.12

• Onset of cardiovascular event (all subjects)

  2015.01-2017.12

• Onset of serious adverse event(all subjects)

  2015.01-2017.12

Study Arms (2)

trial group(tolvaptan group)

ACTIVE COMPARATOR

trial group (tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv,n=20)

Drug: tolvaptan+torasemide

control group

PLACEBO COMPARATOR

control group(placebo 15mg/d po(10 days) +torasemide 20mg/d iv,n=20)

Drug: placebo+torasemide

Interventions

tolvaptan+torasemide DRUG

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

trial group(tolvaptan group)

placebo+torasemide DRUG

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

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

FangYuan

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 30255476 DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Heart Failure

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Fang Yuan

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: January 1, 2016
• Study Start: November 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 20, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)