- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01028170
Safety and Efficacy of Low Dose Hypertonic Saline Solution and High Dose Furosemide for Congestive Heart Failure (REaCH)
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
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Wausau, Wisconsin, United States, 54401
- Aspirus Wausau Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Uncompensated CHF
Framingham Criteria for HF
- 2 Major or
- 1 Major 2 minor
Major criteria:
- Paroxysmal nocturnal dyspnea
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Furosemide with Hypertonic Saline
Furosemide with 150 mL of 2.4% NaCl
|
250-500 mg furosemide (30 min IV Q 12 hours) with 150 mL of 2.4% NaCl
|
Active Comparator: Pulse Furosemide
80-160 mg furosemide (Given over 5 min IV twice a day)
|
80-160 mg furosemide (Given over 5 min IV twice a day)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Renal function (GFR)
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of hospital stay
Time Frame: 30 days
|
30 days
|
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)
Time Frame: one week
|
one week
|
Readmission rate
Time Frame: 6 months
|
6 months
|
Weight loss
Time Frame: one week
|
one week
|
BNP Levels
Time Frame: discharge, 30 days and 6 months
|
discharge, 30 days and 6 months
|
Hospitalization cost analysis
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Richard S Engelmeier, MD, Aspirus Heart and Vascular Institute-Research and Education
- Study Director: German Larrain, MD, Aspirus Heart and Vascular Institute-Research and Education
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Kidney Diseases
- Urologic Diseases
- Heart Failure
- Renal Insufficiency
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Potassium Chloride Symporter Inhibitors
- Furosemide
Other Study ID Numbers
- REaCH-23.07.09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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