CardiomyopathyPhase 1ADD-ITNCT02646540

AiDing Diuresis wIth Tolvaptan (ADD-IT)

A Phase 1 study testing Tolvaptan 30 mg + IV Diuretics, Metolazone 5 mg + IV Diuretics and 2.5 times the Diuretics Dose in people with Cardiomyopathy and Congestive Heart Failure, run by Emory University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to test the use of tolvaptan (commercial name Samsca) when given in addition to intravenous (IV) diuretics early during an episode of acute heart failure. It will be compared to a high dose of IV diuretics alone or the use of metolazone in addition to IV diuretics. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiomyopathy, Congestive Heart Failure
What is being tested?: Tolvaptan 30 mg + IV Diuretics, Metolazone 5 mg + IV Diuretics and 2.5 times the Diuretics Dose
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 2 sitesUnited States
Study dates: Jan 2016to 30 Dec 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
Able to understand content of and willing to provide written informed consent
The participant must have signs of extracellular volume expansion, defined as two or more of the following four signs or symptoms:
signs of RHF (right heart failure) (jugular venous distention, pitting edema, or (≥1+), ascites and/or signs of LHF (left heart failure) (pulmonary congestion on chest x-ray, pulmonary rales)
Brain Natriuretic Peptide (BNP) > 450
serum sodium < 140 mEq/L

Who cannot join

Positive urine pregnancy test for women of child bearing potential
Inability to provide written informed consent
Cardiac surgery within 60 days prior to study randomization
Acute Coronary Syndrome (ACS) or percutaneous coronary intervention within 30 days prior to study randomization
Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization
Planned electrophysiologic (EP) device implantation within 7 days following study randomization

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Subjects who are on cardiac mechanical support
Co- morbid condition with an expected survival less than six months
History of a cerebrovascular accident within the last 30 days
Hemodynamically significant uncorrected primary cardiac valvular disease
Hypertrophic cardiomyopathy (obstructive or non-obstructive)
Uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy
History of primary significant liver disease or acute hepatic failure, defined as 3x upper limit of normal (ULN)
Chronic uncontrolled diabetes mellitus with Hemoglobin A1C > 10%
Supine systolic arterial blood pressure < 90 mmHg
Serum creatinine > 3.5 mg/dL or undergoing dialysis
Hemoglobin < 9 g/dL
History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazepril)
Inability to take oral medications
Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted
Previous exposure to tolvaptan within 7 days prior to randomization
Subjects with refractory, end-stage, heart failure defined as subjects who are appropriate candidates for specialized treatment strategies, such as ventricular assist devices, continuous positive IV inotropic therapy, or hospice care
Ultrafiltration within 7 days prior to randomization or planned.
Active gout

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322

Other trials in United States

About this study

Read the detailed description

This is a single-center, randomized trial to assess the effects of 30 mg daily of tolvaptan when given concomitantly with home dose of diuretic (Lasix equivalent) intravenously (IV) versus 5mg daily of metolazone given concomitantly with home dose of diuretic (Lasix equivalent) IV, versus 2.5 times home dose of diuretic (Lasix equivalent) IV in participants hospitalized for acutely decompensated heart failure (ADHF).

Conditions: Cardiomyopathy, Congestive Heart Failure
Being tested: Tolvaptan 30 mg + IV Diuretics, Metolazone 5 mg + IV Diuretics, 2.5 times the Diuretics Dose
Medical subject headings: Cardiomyopathies, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tolvaptan 30 mg + IV DiureticsDrug
Also called Tolvaptan (Samsca) and Lasix (Furosemide)
Participants will receive oral daily tolvaptan 30 mg concomitantly with their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.
Metolazone 5 mg + IV DiureticsDrug
Also called Metolazone (Zaroxolyn) and Lasix (Furosemide)
Participants will receive oral daily metolazone 5 mg concomitantly with their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.
2.5 times the Diuretics DoseDrug
Also called Lasix (Furosemide)
Participants will receive two and a half (2.5) times their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.

Study groups in NCT02646540
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Metolazone 5 mg + IV Diuretics
IV Lasix	Active comparator	Participants admitted to the hospital and diagnosed with acutely decompensated heart failure (ADHF) will receive two and a half (2.5) times their standard dose of diuretics. Receives: Drug: 2.5 times the Diuretics Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (8)

Change in Body Weight
The difference in body weight from hospital admission to discharge measured in kilograms.
Measured: Baseline (hospital admission), Discharge (Average of 5 Days)
Total Diuretic Dose
The total dose of diuretics given throughout the duration of hospitalization measured in milligrams (mg).
Measured: Up to Five Days
Change in estimated glomerular filtration rate (eGFR)
The difference in eGFR from baseline (hospital admission) to discharge.
Measured: Baseline (hospital admission), Discharge (Average of 5 days)
Number of Days Alive
The number of days participants remain alive over thirty days after hospital discharge.
Measured: Post Hospital Discharge (30 days)
Rate of Re-Hospitalization
The number of participants re-hospitalized for worsening heart failure or death at 30 days.
Measured: 30 Days Post Hospitalization
Number of Electrolyte Imbalance Related Adverse Events
The number of adverse events due to electrolyte imbalance throughout the duration of hospitalization.
Measured: Duration of Hospitalization (Average of Five Days)
Number of Participants Requiring Electrolyte Repletion
The number of participants that require electrolyte repletion throughout the duration of hospitalization.
Measured: Duration of Hospitalization (Average of Five Days)
Change in Sodium Level
The difference in sodium levels from baseline to hospital discharge measured in milliequivalents per liter (mEqL).
Measured: Baseline (hospital admission), Discharge (Average of 5 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201630 Dec 2018

First posted5 Jan 2016 (estimated)
Study startJan 2016
Primary completion30 Dec 2018
Study completion30 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CardiomyopathyStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02646540
Sponsor's protocol ID: IRB00080051
Acronym: ADD-IT
Status last verified: Mar 2019
First submitted: 4 Jan 2016
Last updated: 27 Mar 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiomyopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AiDing Diuresis wIth Tolvaptan (ADD-IT)
ClinicalTrials.gov ID: NCT02646540
Acronym / sponsor ID: ADD-IT / IRB00080051
Conditions: Cardiomyopathy, Congestive Heart Failure
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Study start: Jan 2016
Primary completion: 30 Dec 2018 (actual)
Study completion: 30 Dec 2018 (actual)
First posted: 5 Jan 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Tolvaptan 30 mg and IV Lasix	Experimental	Drug: Tolvaptan 30 mg + IV DiureticsParticipants 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.
Metolazone 5mg and IV Lasix	Active comparator	Drug: Metolazone 5 mg + IV DiureticsParticipants admitted to the hospital and diagnosed with acutely decompensated heart failure (ADHF) will receive 5mg metolazone concomitantly with their standard dose of diuretics.
IV Lasix	Active comparator	Drug: 2.5 times the Diuretics DoseParticipants admitted to the hospital and diagnosed with acutely decompensated heart failure (ADHF) will receive two and a half (2.5) times their standard dose of diuretics.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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
Able to understand content of and willing to provide written informed consent
The participant must have signs of extracellular volume expansion, defined as two or more of the following four signs or symptoms:
signs of RHF (right heart failure) (jugular venous distention, pitting edema, or (≥1+), ascites and/or signs of LHF (left heart failure) (pulmonary congestion on chest x-ray, pulmonary rales)

Key exclusion criteria (24 listed)

Positive urine pregnancy test for women of child bearing potential
Inability to provide written informed consent
Cardiac surgery within 60 days prior to study randomization
Acute Coronary Syndrome (ACS) or percutaneous coronary intervention within 30 days prior to study randomization
Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tolvaptan 30 mg + IV DiureticsAlso: Tolvaptan (Samsca) and Lasix (Furosemide)Participants will receive oral daily tolvaptan 30 mg concomitantly with their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.	Drug	Tolvaptan 30 mg and IV Lasix
Metolazone 5 mg + IV DiureticsAlso: Metolazone (Zaroxolyn) and Lasix (Furosemide)Participants will receive oral daily metolazone 5 mg concomitantly with their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.	Drug	Metolazone 5mg and IV Lasix
2.5 times the Diuretics DoseAlso: Lasix (Furosemide)Participants will receive two and a half (2.5) times their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.	Drug	IV Lasix

Primary outcome

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

8 secondary outcomes

Change in Body Weight
Time frame: Baseline (hospital admission), Discharge (Average of 5 Days)
Total Diuretic Dose
Time frame: Up to Five Days
Change in estimated glomerular filtration rate (eGFR)
Time frame: Baseline (hospital admission), Discharge (Average of 5 days)
Number of Days Alive
Time frame: Post Hospital Discharge (30 days)
Rate of Re-Hospitalization
Time frame: 30 Days Post Hospitalization
Number of Electrolyte Imbalance Related Adverse Events
Time frame: Duration of Hospitalization (Average of Five Days)
Number of Participants Requiring Electrolyte Repletion
Time frame: Duration of Hospitalization (Average of Five Days)
Change in Sodium Level
Time frame: Baseline (hospital admission), Discharge (Average of 5 days)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.

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RecruitingObservational study
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Rare Disorders, Undiagnosed Disorders
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Heart Failure, Left Ventricular Dysfunction
RecruitingPhase 1/2
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Divya Gupta, MD principal investigator

Emory University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of Hospitalization Measured in Days (time frame: Duration of Hospitalization (Average of Five Days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02646540.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019; AzTrials last refreshed its copy on 29 Oct 2026.