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Congestive Heart FailurePhase 2NCT00575484

Concentrated Saline Infusions and Increased Dietary Sodium With Diuretics for Heart Failure With Kidney Dysfunction

A Phase 2 study testing Hypertonic saline, then oral sodium chloride in people with Congestive Heart Failure and Renal Insufficiency, run by Barnes-Jewish Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

At present the standard management of fluid overload in patients with congestive heart failure (CHF) involves limiting the intake of salt and water while administering high dose diuretics, often at the cost of deteriorating kidney function. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Congestive Heart Failure, Renal Insufficiency
What is being tested?
Hypertonic saline, then oral sodium chloride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
11 participants
Where
1 siteUnited States
Study dates
Nov 2007to Jul 2008
Phase
Phase 2
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

  • Adult patients (age ≥18) admitted with CHF exacerbation with NYHA Class III-IV symptoms at screening.
  • Left ventricular ejection fraction </= 45%, as determined by previous echocardiogram, left ventricular angiogram, or thallium myocardial imaging.
  • Estimated GFR <60 ml/min/1.7m² with significant prerenal physiology as judged by prior documented volume mediated changes in renal function, a fractional excretion of urea <35%, or a fractional excretion of sodium <1%. For GFR 30-60: must have serum sodium </= 135 mEq/L OR large home diuretic dose (total daily loop diuretic dose >/= 120 mg/d in furosemide equivalents OR concomitant thiazide use). For GFR <30: no additional criteria needed.

Who cannot join

  • Admit estimated GFR < 15mL/min or predicted need for chronic hemodialysis within the next 60 days.
  • Cause of acute kidney injury other than prerenal physiology.
  • No loop diuretic prior to admission or loop diuretic initiated within the 2 wks prior to admission.
  • Medicine or dietary noncompliance expected to prevent successful study participation.
  • > 36hrs since presentation to screening.
  • Serum Na > 145 mEq/L OR < 120 mEq/L at screening.
Show all 16Show fewer
  • Systolic blood pressure > 180 mmHg at screening.
  • Presentation with acute coronary syndrome OR left heart catheterization planned at screening.
  • Current or impending respiratory failure at screening.
  • Current calcineurin inhibitor or nesiritide use.
  • Nephrotic-range proteinuria.
  • Clinical evidence for the presence of cirrhosis with bilirubin >/= 2mg/dL or international normalized ratio (not on coumadin) >/= 1.7.
  • Presence of another active medical issue which may prolong hospital admission or delay aggressive CHF therapy.
  • Participation in another interventional study.
  • Pregnancy.
  • Prisoners.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Barnes-Jewish Hospital; Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Hypertonic Saline With Furosemide and a Normosodic Diet for the Treatment of Decompensated Congestive Heart Failure With Prerenal Physiology

At present the standard management of fluid overload in patients with congestive heart failure (CHF) involves limiting the intake of salt and water while administering high dose diuretics, often at the cost of deteriorating kidney function. However, another group of researchers has previously shown that intravenously infusing small volumes of concentrated saline during diuretic dosing and liberalizing dietary salt intake while continuing to limit water consumption resulted in improved fluid removal in CHF patients. Furthermore, less deterioration in kidney function, shorter hospitalizations, reduced readmission rates, and even reduced mortality were observed. The present study will examine this novel therapy in a population of 60 patients with underlying severe CHF and kidney dysfunction hospitalized for the management of fluid overload. Half of these patients will receive investigational treatment with concentrated salt infusions and liberalized salt consumption during diuretic therapy. All patients will otherwise receive the standard therapies for heart failure, including restrictions on water consumption. This study will attempt to verify the improvements in clinical endpoints previously described and define the mechanisms of enhanced fluid removal.

Being tested
Hypertonic saline, then oral sodium chloride, Normal saline, then oral placebo capsule
Keywords
Congestive Heart Failure, Renal Insufficiency, Hypertonic Saline Solution, Diuretic Resistance, Cardiorenal Syndrome
Medical subject headings
Heart Failure, Renal Insufficiency, Cardio-Renal Syndrome

What participants receive

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

  • Hypertonic saline, then oral sodium chlorideDrug

    2mL/kg hypertonic saline (4.4% NaCl if serum sodium </=135, else 2.8% NaCl) infused over 30min BID and dosed simultaneously with IV bolus furosemide BID (latter dose per treating physician) until patient is switched to oral loop diuretic. After switch to oral diuretic, subject will receive oral 0.75gm sodium (NaCL) capsule dosed BID with loop diuretic (latter dose per treating physician) until 60d after discharge.

  • Normal saline, then oral placebo capsuleDrug

    20mL normal saline infusion X 30min BID dosed simultaneously with IV bolus furosemide BID (latter dose per treating physician) PLUS 2gm sodium diet PLUS 1.5L fluid restriction. After switch to oral diuretic, begin oral placebo capsule BID, dosed with loop diuretic (dose per treating physician) PLUS 2gm sodium diet PLUS 1.5L fluid restriction.

Study groups in NCT00575484
Study groupRoleWhat they receive
1Placebo comparatorNot described
Receives: Drug: Normal saline, then oral placebo capsule
2Active comparatorNot described
Receives: Drug: Hypertonic saline, then oral sodium chloride

What is being measured

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

  1. duration of hospitalization

    Measured: duration of hospitalization

  2. weight loss at discharge

    Measured: duration of hospitalization

  3. weight loss at 60 days

    Measured: 60 days after discharge

Secondary outcomes (5)

  1. number of readmissions

    Measured: 60 days after discharge

  2. GFR by creatinine clearance at discharge

    Measured: duration of hospitalization

  3. estimated GFR at 60 days after discharge

    Measured: 60 days after discharge

  4. 24hr urine output at discharge

    Measured: last 24hrs of hospitalization

  5. need for inotrope or extracorporeal volume removal

    Measured: 60 days after discharge

Timeline

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

  1. First posted18 Dec 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00575484
Sponsor's protocol ID
00904-0407-01
Status last verified
Jan 2014
First submitted
17 Dec 2007
Last updated
24 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Paterna S, Parrinello G, Amato P, Dominguez L, Pinto A, Maniscalchi T, Cardinale A, Licata A, Amato V, Licata G, Di Pasquale P. Tolerability and efficacy of high-dose furosemide and small-volume hypertonic saline solution in refractory congestive heart failure. Adv Ther. 1999 Sep-Oct;16(5):219-28.

    PubMed 10915397

  • Paterna S, Di Pasquale P, Parrinello G, Amato P, Cardinale A, Follone G, Giubilato A, Licata G. Effects of high-dose furosemide and small-volume hypertonic saline solution infusion in comparison with a high dose of furosemide as a bolus, in refractory congestive heart failure. Eur J Heart Fail. 2000 Sep;2(3):305-13. doi: 10.1016/s1388-9842(00)00094-5.

    PubMed 10938493

  • Licata G, Di Pasquale P, Parrinello G, Cardinale A, Scandurra A, Follone G, Argano C, Tuttolomondo A, Paterna S. Effects of high-dose furosemide and small-volume hypertonic saline solution infusion in comparison with a high dose of furosemide as bolus in refractory congestive heart failure: long-term effects. Am Heart J. 2003 Mar;145(3):459-66. doi: 10.1067/mhj.2003.166.

    PubMed 12660669

  • Paterna S, Di Pasquale P, Parrinello G, Fornaciari E, Di Gaudio F, Fasullo S, Giammanco M, Sarullo FM, Licata G. Changes in brain natriuretic peptide levels and bioelectrical impedance measurements after treatment with high-dose furosemide and hypertonic saline solution versus high-dose furosemide alone in refractory congestive heart failure: a double-blind study. J Am Coll Cardiol. 2005 Jun 21;45(12):1997-2003. doi: 10.1016/j.jacc.2005.01.059.

    PubMed 15963399

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hypertonic saline, then oral sodium chloride in people with Congestive Heart Failure and Renal Insufficiency, run by Barnes-Jewish Hospital at 1 site in United States.

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 3 inclusion and 16 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: stopped early, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early. Results are not available in the source record.

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?

duration of hospitalization (time frame: duration of hospitalization). The study lists 3 primary outcomes in all. 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 NCT00575484, which also lists 4 linked publications.

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 24 Jan 2014; AzTrials last refreshed its copy on 6 Nov 2026.

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