Trials Sponsors Conditions Drugs Pricing

Conditions

Cardiomyopathy Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

Length of Hospitalization Measured in Days
The number of days hospitalized until discharge.
Duration of Hospitalization (Average of Five Days)

Secondary Outcomes (8)

Change in Body Weight
Baseline (hospital admission), Discharge (Average of 5 Days)
Total Diuretic Dose
Up to Five Days
Change in estimated glomerular filtration rate (eGFR)
Baseline (hospital admission), Discharge (Average of 5 days)
Number of Days Alive
Post Hospital Discharge (30 days)
Rate of Re-Hospitalization
30 Days Post Hospitalization
+3 more secondary outcomes

Study Arms (3)

Tolvaptan 30 mg and IV Lasix

EXPERIMENTAL

Participants admitted to the hospital and diagnosed with acutely decompensated heart failure (ADHF) will receive 30 mg of tolvaptan concomitantly with their standard dose of diuretics.

Drug: Tolvaptan 30 mg + IV Diuretics

Metolazone 5mg and IV Lasix

ACTIVE COMPARATOR

Participants admitted to the hospital and diagnosed with acutely decompensated heart failure (ADHF) will receive 5mg metolazone concomitantly with their standard dose of diuretics.

Drug: Metolazone 5 mg + IV Diuretics

IV Lasix

ACTIVE COMPARATOR

Interventions

Tolvaptan 30 mg + IV DiureticsDrug

Participants will receive oral daily tolvaptan 30 mg concomitantly with their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.

Also known as: Tolvaptan (Samsca) and Lasix (Furosemide)

Tolvaptan 30 mg and IV Lasix

Metolazone 5 mg + IV DiureticsDrug

Participants will receive oral daily metolazone 5 mg concomitantly with their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants hospitalized for worsening acute heart failure and randomized within 36 hours of initial presentation
New York Heart Association (NYHA) Class III or IV on admission to the hospital with at least 1 month history of treated heart failure

Sponsors & Collaborators

Emory University
Otherlead

Study Sites (2)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Emory University Hospital

Atlanta, Georgia, 30322, United States

MeSH Terms

Conditions

CardiomyopathiesHeart Failure

Interventions

TolvaptanDiureticsFurosemideMetolazone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNatriuretic Agents

Study Officials

Divya Gupta, MD
Emory University
PRINCIPAL INVESTIGATOR

Enrollment

14 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 5, 2016

Study Start

January 2016

Date type not reported

This date has not been verified as actual or estimated.

AiDing Diuresis wIth Tolvaptan (ADD-IT)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (3)

Tolvaptan 30 mg and IV Lasix

Metolazone 5mg and IV Lasix

IV Lasix

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (3)

Tolvaptan 30 mg and IV Lasix

Metolazone 5mg and IV Lasix

IV Lasix

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations