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

• Sponsor: Shanghai Chest Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02644616
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Regurgitation; Right Heart Failure	Drug: tolvaptan+torasemide; Drug: placebo+torasemide	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: trial group(tolvaptan group) trial group (tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv,n=20)	Drug: tolvaptan+torasemide; tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv
Placebo Comparator: control group control group(placebo 15mg/d po(10 days) +torasemide 20mg/d iv,n=20)	Drug: placebo+torasemide; placebo 15mg/d po(10 days) +torasemide 20mg/d iv

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. A cumulative urine volume for 72 hours (all subjects) [2015.01-2017.12]

2. Echocardiography results VS the baseline results(all subjects) [2015.01-2017.12]

3. Change of right heart failure signs(all subjects) [2015.01-2017.12]

4. Onset of cardiovascular event (all subjects) [2015.01-2017.12]

5. Onset of serious adverse event(all subjects) [2015.01-2017.12]

6. other adverse events(all subjects) [2015.01-2017.12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient with tricuspid regurgitation and right heart failure after left heart valves replacement

2. Patients who takes existing diuretic

3. The patient is willing to participate in the study

Exclusion Criteria:

1. Patients with hypersensitivity to study drug

2. Anuric patients

3. Patients with hypernatremia

4. Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant

5. Malignant tumor

6. Patients with serious hepatic disorder or Serious Renal failure

7. Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	FangYuan	Shanghai	Shanghai	China

Sponsors and Collaborators

• Shanghai Chest Hospital

Investigators

• Principal Investigator: Fang Yuan, Shanghai Chest Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuan Fang, Principal Investigator, Shanghai Chest Hospital
• ClinicalTrials.gov Identifier: NCT02644616
• Other Study ID Numbers: 156-ZOC-1401
• First Posted: Jan 1, 2016
• Last Update Posted: Dec 20, 2016
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Yuan Fang, Principal Investigator, Shanghai Chest Hospital: tolvaptan; safety and efficacy; left heart valves replacement
• Additional relevant MeSH terms: Heart Failure; Tricuspid Valve Insufficiency; Torsemide; Tolvaptan

Study Results

No Results Posted as of Dec 20, 2016