Heart Failure Clinical Trial

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

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. 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).

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Full 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).

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Eligibility Criteria

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 is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

50

Study ID:

NCT01028170

Recruitment Status:

Completed

Sponsor:

Aspirus Heart and Vascular Institute-Research and Education

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There is 1 Location for this study

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Aspirus Wausau Hospital
Wausau Wisconsin, 54401, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

50

Study ID:

NCT01028170

Recruitment Status:

Completed

Sponsor:


Aspirus Heart and Vascular Institute-Research and Education

How clear is this clinincal trial information?

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