Trial · NCT01644331

Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure

NCT01644331, Phase 3, Completed, Duke University; results first posted 2017-04-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure. Trials, record NCT01644331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01644331

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure
NCT number: NCT01644331
Status: Completed
Phases: Phase 3
Enrollment: 257 participants, actual
Lead sponsor: Duke University
Conditions: Heart Failure, Dyspnea
Interventions: Tolvaptan, Placebo
First posted: 2012-07-19
Last updated: 2017-04-27
Results first posted: 2017-04-27

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours	8 and 24 hours	The number of patients with at least moderate improvement (as reported by patient) in dyspnea Likert scale at both 8 AND 24 hours AND without the need for escalation of therapy due to worsening heart failure (rescue therapy) or death within 24 hours.
Secondary	Renal Function	0, 24, 48 and 72 hours	Change in Serum creatinine from baseline to 24, 48 and 72 hours
Secondary	Weight Loss	0, 24, 48, and 72 hours	Change in body weight from baseline to 24, 48, and 72 hours
Secondary	Fluid Loss	0, 24, 48, and 72 hours	Change from baseline fluid balance at 24, 48, and 72 hours
Secondary	Dyspnea Likert	48 and 72 hours	Number of patients that experience moderate or greater improvement (patient reported) in dyspnea by 7 point Likert scale at 48 and 72 hours
Secondary	Hospital Stay	7 days	Total days spent in hospital from baseline until discharge or death
Secondary	Worsening or Persistent Heart Failure or Death	72 hrs	Number of patients with worsening heart failure or death
Secondary	Over-diuresis	72 hours	clinical evidence of volume depletion requiring intervention other than holding diuretics during the 72 hours after randomization
Secondary	Serum Sodium	0, 24, 48, and 72 hours	Change in serum sodium from baseline to 24, 48, and 72 hours
Secondary	Dyspnea 11 Point NRS	0, 24, 48, and 72 hours	Change in NRS for assessment of dyspnea from baseline to 24, 48, and 72 hours (scale ranges from 0-No difficulty breathing to 10-Difficulty as bad as you can imagine)

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours	8 and 24 hours	Baseline population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Renal Function	0, 24, 48 and 72 hours	Baseline population	mg/dL	MEAN
SECONDARY	Weight Loss	0, 24, 48, and 72 hours	Baseline population	lbs	MEAN
SECONDARY	Fluid Loss	0, 24, 48, and 72 hours	baseline population	mL	MEAN
SECONDARY	Dyspnea Likert	48 and 72 hours	baseline population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Hospital Stay	7 days	baseline population	days	MEAN
SECONDARY	Worsening or Persistent Heart Failure or Death	72 hrs	baseline population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Over-diuresis	72 hours	baseline population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Serum Sodium	0, 24, 48, and 72 hours	baseline population	mmol/L	MEAN
SECONDARY	Dyspnea 11 Point NRS	0, 24, 48, and 72 hours	baseline population	units on a scale	MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group54

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours	Tolvaptan		20		Participants
Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours	Placebo		26		Participants
Renal Function	Tolvaptan	24 hours	0.13	Standard Deviation 0.4	mg/dL
Renal Function	Placebo	24 hours	0.04	Standard Deviation 0.3	mg/dL
Renal Function	Tolvaptan	48 hours	0.10	Standard Deviation 0.4	mg/dL
Renal Function	Placebo	48 hours	0.05	Standard Deviation 0.4	mg/dL
Renal Function	Tolvaptan	72 hours	0.03	Standard Deviation 0.6	mg/dL
Renal Function	Placebo	72 hours	0.06	Standard Deviation 0.4	mg/dL
Weight Loss	Tolvaptan	24 hours	-4.41	Standard Deviation 6.6	lbs
Weight Loss	Placebo	24 hours	-1.16	Standard Deviation 13.2	lbs

1 to 10 of 54Source ClinicalTrials.gov

See all 54 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tolvaptan	129
Overall Study	STARTED	Placebo	128
Overall Study	COMPLETED	Tolvaptan	118
Overall Study	COMPLETED	Placebo	118
Overall Study	NOT COMPLETED	Tolvaptan	11
Overall Study	NOT COMPLETED	Placebo	10

Source ClinicalTrials.gov

Adverse events32

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Atrial Fibrillation	Cardiac disorders	Tolvaptan	13	129	13
other	Atrial Fibrillation	Cardiac disorders	Placebo	19	128	19
other	Ventricular Tachycardia	Cardiac disorders	Tolvaptan	5	129	5
other	Ventricular Tachycardia	Cardiac disorders	Placebo	7	128	7
other	Myocardial Infarction	Cardiac disorders	Tolvaptan	1	129	1
other	Myocardial Infarction	Cardiac disorders	Placebo	0	128	0
other	Acute Coronary Syndrome	Cardiac disorders	Tolvaptan	1	129	1
other	Acute Coronary Syndrome	Cardiac disorders	Placebo	0	128	0
other	Acute Renal Failure	Renal and urinary disorders	Tolvaptan	24	129	24
other	Acute Renal Failure	Renal and urinary disorders	Placebo	15	128	15

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tolvaptan
Total, all-cause mortality	Placebo
Total, other adverse events	Tolvaptan	101	129
Total, other adverse events	Placebo	107	128
Total, serious adverse events	Tolvaptan	8	129
Total, serious adverse events	Placebo	2	128

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27654854	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Tolvaptan vs Placebo: Over-diuresis	Trial comparisons
Tolvaptan vs Placebo: Development of Worsening Renal Function	Trial comparisons
Tolvaptan vs Placebo: Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours	Trial comparisons
Tolvaptan vs Placebo: Worsening or Persistent Heart Failure or Death	Trial comparisons
Tolvaptan vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01644331

GET https://conductscience.org/api/trials/v1/NCT01644331/results?page=2

API reference For AI assistants