AzTrials
AzTrials

Congestive Heart FailurePhase 3REaCHNCT01028170

Safety and Efficacy of Low Dose Hypertonic Saline Solution and High Dose Furosemide for Congestive Heart Failure

A Phase 3 study testing furosemide and hypertonic saline solution and furosemide in people with Congestive Heart Failure and Renal Insufficiency, run by Aspirus Heart and Vascular Institute-Research and Education at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to compare high dose furosemide in combination with low volume hypertonic saline solution (2.4%) with intermittent pulse dose furosemide in patients with pre treatment kidney function impairment. 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?
furosemide and hypertonic saline solution and furosemide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Nov 2009to Jan 2012
Phase
Phase 3
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

  • Uncompensated CHF
  • Framingham Criteria for HF
  • 2 Major or
  • 1 Major 2 minor
  • Major criteria:
  • Paroxysmal nocturnal dyspnea
Show all 26Show fewer
  • Neck vein distention
  • Rales
  • Radiographic cardiomegaly (increasing heart size on chest radiography)
  • Acute pulmonary edema
  • S3 gallop
  • Increased central venous pressure (>16 cm H2O at right atrium)
  • Hepatojugular reflux
  • Weight loss > 4.5 kg in 5 days in response to treatment
  • Minor criteria:
  • Bilateral ankle edema
  • Nocturnal cough
  • Dyspnea on ordinary exertion
  • Hepatomegaly
  • Pleural effusion
  • Decrease in vital capacity by one third from maximum recorded
  • Tachycardia (heart rate>120 beats/min.)
  • No Ejection Fraction Inclusion Criteria
  • GFR £ 60 mL/min
  • GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if African American) (conventional units).
  • Informed consent

Who cannot join

  • Patients with Acute Coronary Syndrome
  • Post -op patients within 90 days of previous surgery
  • Patients currently on dialysis
  • Hospice patients
  • Patients < 18 years of age.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401

Other trials in United States

About this study

Official title: Assessing the Renal Consequences and Functional Efficacy of Low Dose Hypertonic Saline Solution and Furosemide for the Treatment of Congestive Heart Failure in a Randomized, Double Blind, Prospective Study

The purpose of this study is to compare high dose furosemide in combination with low volume hypertonic saline solution (2.4%) with intermittent pulse dose furosemide in patients with pre treatment kidney function impairment. The hypothesis is that it will provide effective diuretic response and have a beneficial effect on preservation of renal function as compared to pulse furosemide in patients with pre-treatment renal impairment (GFR < 60 mL/min).

Read the detailed description

Currently, congestive heart failure (CHF) is the fastest growing heart-related diagnosis in North America, with the chance of a person experiencing it during their lifetime around 20%. In patients with CHF, acute decompensation requiring hospitalizations are common. Patients with renal insufficiency are more susceptible to worsening of renal function or overt renal failure in relation to an episode of decompensated heart failure. Thus, there is a great need for treatment to help patients with renal dysfunction that can simultaneously protect them from further renal deterioration. Preliminary evidence indicates that hypertonic saline solution (HSS) combined with high dose loop diuretics may improve the prognosis for patients with CHF. In two separate studies, this treatment was found to alleviate symptoms of CHF, and significantly reduce hospital length of stay, as well as reduce morbidity and mortality subsequent to hospital stay. So far, available studies have demonstrated that renal function is not compromised when using HSS and high dose furosemide as a treatment for CHF. Preliminary data from our institution suggests that low volume HSS combined with high dose furosemide may be beneficial for patients with renal insufficiency.

Hypothesis:

High dose furosemide in combination with low volume HSS provides effective diuretic response and has a beneficial effect on preservation of renal function while in hospital as compared to pulse furosemide in patients with pre-treatment renal impairment (GFR < 60 mL/min).

Being tested
furosemide and hypertonic saline solution, furosemide
Keywords
Congestive Heart Failure, Renal Insufficiency, Cardio-renal 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.

  • furosemide and hypertonic saline solutionDrug

    250-500 mg furosemide (30 min IV Q 12 hours) with 150 mL of 2.4% NaCl

  • furosemideDrug

    80-160 mg furosemide (Given over 5 min IV twice a day)

Study groups in NCT01028170
Study groupRoleWhat they receive
Furosemide with Hypertonic SalineExperimentalFurosemide with 150 mL of 2.4% NaCl
Receives: Drug: furosemide and hypertonic saline solution
Pulse FurosemideActive comparator80-160 mg furosemide (Given over 5 min IV twice a day)
Receives: Drug: furosemide

What is being measured

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

  1. Renal function (GFR)

    Measured: 30 days

Secondary outcomes (6)

  1. Diuretic response (defined as achievement of weight within 2% of previously determined dry body weight or reaching a clinically compensated state including return of functional level to prior NYHA class as determined by the primary treating physician)

    Measured: one week

  2. Length of hospital stay

    Measured: 30 days

  3. Readmission rate

    Measured: 6 months

  4. Weight loss

    Measured: one week

  5. BNP Levels

    Measured: discharge, 30 days and 6 months

  6. Hospitalization cost analysis

    Measured: 30 days

Timeline

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

  1. First posted9 Dec 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionJul 2011
  4. Study completionJan 2012

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01028170
Sponsor's protocol ID
REaCH-23.07.09
Acronym
REaCH
Status last verified
Feb 2012
First submitted
27 Nov 2009
Last updated
9 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • MacIntyre K, Capewell S, Stewart S, Chalmers JW, Boyd J, Finlayson A, Redpath A, Pell JP, McMurray JJ. Evidence of improving prognosis in heart failure: trends in case fatality in 66 547 patients hospitalized between 1986 and 1995. Circulation. 2000 Sep 5;102(10):1126-31. doi: 10.1161/01.cir.102.10.1126.

    PubMed 10973841

  • Lapman PG, Golduber GN, Le Jemtel TH. Heart failure treatment and renal function. Am Heart J. 2004 Feb;147(2):193-4. doi: 10.1016/j.ahj.2003.10.003. No abstract available.

    PubMed 14760310

  • 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

  • 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 3 study testing furosemide and hypertonic saline solution and furosemide in people with Congestive Heart Failure and Renal Insufficiency, run by Aspirus Heart and Vascular Institute-Research and Education 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 26 inclusion and 5 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 9 Feb 2012. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Renal function (GFR) (time frame: 30 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 NCT01028170, which also lists 5 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 9 Feb 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in