CLINICAL TRIALS PROFILE FOR ISORDIL
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All Clinical Trials for ISORDIL
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00170183 ↗ | Brain Natriuretic Peptide (BNP) to Preserve Renal Function in Hospitalized Patients With Heart Failure | Completed | Scios, Inc. | Phase 3 | 2003-03-01 | Patients hospitalized for treatment of decompensated heart failure (CHF) are at risk for prolonged length of stay (LOS) and frequent readmissions. Renal dysfunction and diuretic resistance contribute to this risk, particularly if renal dysfunction worsens during CHF treatment. Brain natriuretic peptide (BNP) is a hormone of myocardial cell origin with well-defined physiological effects which include arterial and venous vasodilation, suppression of adverse neurohumoral systems and favorable effects on renal hemodynamics and sodium excretion. Recombinant human BNP (Natrecor) is approved by the FDA for treatment of decompensated CHF as it has been demonstrated to lower filling pressures and improve symptoms. While clinical trials and the FDA support the use of BNP as adjuvant therapy in decompensated CHF, the extent of its efficacy in improving non-hemodynamic CHF parameters has not been fully defined. The objective of this clinical practice protocol is to determine whether use of BNP in addition to standard therapy, will preserve renal function and facilitate diuresis in patients with CHF and mild-moderate renal impairment (creatinine clearance > 20 but < 60 ml/min) as compared to standard therapy alone. Patients admitted to the Mayo Heart Failure Service who meet entrance criteria will be randomized to standard clinical practice with or without a 48 hour infusion of BNP. The primary endpoints will be indices of renal function and diuretic response at 1, 2 and 3 days and at discharge. Secondary endpoints will be neurohumoral function, LOS and 30-day readmission rate. |
| NCT00170183 ↗ | Brain Natriuretic Peptide (BNP) to Preserve Renal Function in Hospitalized Patients With Heart Failure | Completed | Mayo Clinic | Phase 3 | 2003-03-01 | Patients hospitalized for treatment of decompensated heart failure (CHF) are at risk for prolonged length of stay (LOS) and frequent readmissions. Renal dysfunction and diuretic resistance contribute to this risk, particularly if renal dysfunction worsens during CHF treatment. Brain natriuretic peptide (BNP) is a hormone of myocardial cell origin with well-defined physiological effects which include arterial and venous vasodilation, suppression of adverse neurohumoral systems and favorable effects on renal hemodynamics and sodium excretion. Recombinant human BNP (Natrecor) is approved by the FDA for treatment of decompensated CHF as it has been demonstrated to lower filling pressures and improve symptoms. While clinical trials and the FDA support the use of BNP as adjuvant therapy in decompensated CHF, the extent of its efficacy in improving non-hemodynamic CHF parameters has not been fully defined. The objective of this clinical practice protocol is to determine whether use of BNP in addition to standard therapy, will preserve renal function and facilitate diuresis in patients with CHF and mild-moderate renal impairment (creatinine clearance > 20 but < 60 ml/min) as compared to standard therapy alone. Patients admitted to the Mayo Heart Failure Service who meet entrance criteria will be randomized to standard clinical practice with or without a 48 hour infusion of BNP. The primary endpoints will be indices of renal function and diuretic response at 1, 2 and 3 days and at discharge. Secondary endpoints will be neurohumoral function, LOS and 30-day readmission rate. |
| NCT00262470 ↗ | Treatment of Orthostatic Intolerance | Active, not recruiting | National Institutes of Health (NIH) | Phase 1/Phase 2 | 1997-04-01 | This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder. |
| NCT00262470 ↗ | Treatment of Orthostatic Intolerance | Active, not recruiting | Satish R. Raj | Phase 1/Phase 2 | 1997-04-01 | This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder. |
| NCT01822808 ↗ | Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure | Unknown status | Momentum Research, Inc. | Phase 3 | 2013-01-01 | To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms, cardiac parameters and functional status of African patients hospitalized with AHF and left ventricular dysfunction during 24 weeks of therapy. Administration of hydralazine/nitrates will be superior to placebo administration in reducing HF readmission or death, improving dyspnoea, reducing blood pressure and brain natriuretic peptide (BNP) in African patients admitted with AHF and left ventricular dysfunction. |
| NCT01822808 ↗ | Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure | Unknown status | University of Cape Town | Phase 3 | 2013-01-01 | To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms, cardiac parameters and functional status of African patients hospitalized with AHF and left ventricular dysfunction during 24 weeks of therapy. Administration of hydralazine/nitrates will be superior to placebo administration in reducing HF readmission or death, improving dyspnoea, reducing blood pressure and brain natriuretic peptide (BNP) in African patients admitted with AHF and left ventricular dysfunction. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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