Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders (TROUPER)
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|ClinicalTrials.gov Identifier: NCT02476409|
Recruitment Status : Enrolling by invitation
First Posted : June 19, 2015
Last Update Posted : June 18, 2020
Patients who present to clinic or in the outpatient setting with worsening heart failure represent a unique opportunity for novel approaches to decongestion (removing fluid) that may more rapidly improve fluid status and symptoms as well as reduce the risk of hospitalization.
In these patients with less severe congestion (fluid overload), combining the vasopressin antagonist tolvaptan with loop diuretics (or fluid pills like furosemide/bumetanide/torsemide) may represent a more effective strategy for decongestion. In addition, looking at patients' copeptin levels may help identify those who are more likely to respond to tolvaptan.
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure||Drug: tolvaptan Other: Placebo||Phase 4|
This study will be a randomized, double blind, positive control, multi-center clinical trial enrolling patients who present in the outpatient setting with signs and symptoms consistent with worsening congestive heart failure. The sample size for the study is 40 patients. Candidates for the study will be identified by screening outpatients presenting with worsening heart failure.
Patients who qualify for the study will be enrolled within 24 hours of identification. Patients will be randomized in a 1:1 fashion to one of two treatment arms:
- Augmentation of current daily dose of oral loop diuretic + 30 mg of oral Tolvaptan daily
- Augmentation of current daily dose of oral loop diuretic + placebo of oral Tolvaptan daily
Patients will initiate study medication in a hospital setting and will be observed for a period of time that will depend upon their baseline serum sodium and response to study drug. In most cases patients will be observed for 8 hours. Following this observational period, patients will leave the hospital setting and the remainder of the study will consist of follow-up by outpatient visits or by telephone. All patients will have Day 30 follow up phone contact for assessment of vital status, adverse events and morbidity during this period.
The primary objectives of this study will be to compare the effects of oral tolvaptan plus augmented loop diuretic versus augmented loop diuretic on 1) short term changes in body weight with and without stratification for baseline copeptin and 2) an index targeted to signs and symptoms of congestion in patients presenting with worsening congestive heart failure in the outpatient setting with and without prespecified post hoc stratification based on baseline copeptin level.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Tolvaptan Treatment to Reverse Worsening Outpatient Heart Failure: Possible Role of Copeptin In Identifying Responders (TROUPER)|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
Augmentation of current dose of loop diuretic + 30 mg of oral tolvaptan daily
Study will test the addition of tolvaptan to augmentation of loop diuretic as standard of care for outpatients presenting with worsening heart failure.
Other Name: Samsca
Placebo Comparator: Placebo
Augmentation of current dose of loop diuretic
Placebo for tolvaptan
- Change in body weight at 48 hours [ Time Frame: 48 hours ]The primary endpoint for the study will be change in body weight between patients randomized to tolvaptan versus placebo from baseline to 48 hours with and without stratification for baseline copeptin level
- Changes in congestion (patient reported and investigator assessed) [ Time Frame: 48 hours and day 8 ]
Changes in the patient reported and investigator assessed congestion index based on the Likert scale from baseline to 48 hours. Changes in the patient reported and investigator assessed index of congestion at 8 days based on the Likert scale.
Changes in the patient reported and investigator assessed index of congestion from baseline to 48 hours and 8 days based on the visual analog scale .
- Change in body weight at day 8 [ Time Frame: 8 days ]Change in body weight at 8 days will be analyzed in a similar fashion to the change in body weight at 48 hours
- Clinical composite of morbidity [ Time Frame: 30 days ]This composite will include days of hospitalization, Emergency Department (ED) visits, clinic visits not required by the protocol during the 30 days after randomization into the study
- Exploratory endpoint longitudinal changes in renal function [ Time Frame: 48 hours and day 8 ]Longitudinal changes in renal function
- Exploratory endpoint longitudinal changes in serum sodium [ Time Frame: 48 hours and day 8 ]Longitudinal changes in serum sodium
- Exploratory endpoint longitudinal changes in copeptin [ Time Frame: 48 hours and day 8 ]Longitudinal changes in copeptin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476409
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Kirkwood F Adams, MD||University of North Carolina, Chapel Hill|