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Last Updated: September 26, 2021

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CLINICAL TRIALS PROFILE FOR HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

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All Clinical Trials for Hydralazine Hydrochloride; Isosorbide Dinitrate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01516346 ↗ Vasodilator Therapy for Heart Failure and Preserved Ejection Fraction Active, not recruiting National Institute on Aging (NIA) Phase 2 2012-01-01 The main objective is to test the effect of prolonged therapy (24 weeks) with isosorbide dinitrate ± hydralazine on arterial wave reflections (primary endpoint). Secondary endpoints include left ventricular (LV) mass, fibrosis and diastolic function) and exercise capacity (assessed via the 6-minute walk test) in patients with Heart Failure and Preserved Ejection Fraction (HFPEF). We will also test the hypothesis that the reduction in arterial wave reflections induced by vasoactive therapy will correlate with the improvement in exercise capacity, LV mass, fibrosis and diastolic function. Finally, we will assess whether the hemodynamic response to an acute dose of sublingual nitroglycerin (NTG) can predict the sustained changes in the reflected wave and other hemodynamic parameters in response to chronic vasodilator therapy.
NCT01516346 ↗ Vasodilator Therapy for Heart Failure and Preserved Ejection Fraction Active, not recruiting University of Pennsylvania Phase 2 2012-01-01 The main objective is to test the effect of prolonged therapy (24 weeks) with isosorbide dinitrate ± hydralazine on arterial wave reflections (primary endpoint). Secondary endpoints include left ventricular (LV) mass, fibrosis and diastolic function) and exercise capacity (assessed via the 6-minute walk test) in patients with Heart Failure and Preserved Ejection Fraction (HFPEF). We will also test the hypothesis that the reduction in arterial wave reflections induced by vasoactive therapy will correlate with the improvement in exercise capacity, LV mass, fibrosis and diastolic function. Finally, we will assess whether the hemodynamic response to an acute dose of sublingual nitroglycerin (NTG) can predict the sustained changes in the reflected wave and other hemodynamic parameters in response to chronic vasodilator therapy.
NCT01516346 ↗ Vasodilator Therapy for Heart Failure and Preserved Ejection Fraction Active, not recruiting Corporal Michael J. Crescenz VA Medical Center Phase 2 2012-01-01 The main objective is to test the effect of prolonged therapy (24 weeks) with isosorbide dinitrate ± hydralazine on arterial wave reflections (primary endpoint). Secondary endpoints include left ventricular (LV) mass, fibrosis and diastolic function) and exercise capacity (assessed via the 6-minute walk test) in patients with Heart Failure and Preserved Ejection Fraction (HFPEF). We will also test the hypothesis that the reduction in arterial wave reflections induced by vasoactive therapy will correlate with the improvement in exercise capacity, LV mass, fibrosis and diastolic function. Finally, we will assess whether the hemodynamic response to an acute dose of sublingual nitroglycerin (NTG) can predict the sustained changes in the reflected wave and other hemodynamic parameters in response to chronic vasodilator therapy.
NCT01822808 ↗ Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure Active, not recruiting 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 Active, not recruiting 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 >Phase >Start Date >Summary

Clinical Trial Conditions for Hydralazine Hydrochloride; Isosorbide Dinitrate

Condition Name

Condition Name for Hydralazine Hydrochloride; Isosorbide Dinitrate
Intervention Trials
Heart Failure 4
Acute Heart Failure 1
Left Ventricular Dysfunction 1
Diabetes 1
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Condition MeSH

Condition MeSH for Hydralazine Hydrochloride; Isosorbide Dinitrate
Intervention Trials
Heart Failure 5
Syndrome 1
Cardio-Renal Syndrome 1
Ventricular Dysfunction, Left 1
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Clinical Trial Locations for Hydralazine Hydrochloride; Isosorbide Dinitrate

Trials by Country

Trials by Country for Hydralazine Hydrochloride; Isosorbide Dinitrate
Location Trials
United States 22
Singapore 1
South Africa 1
Denmark 1
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Trials by US State

Trials by US State for Hydralazine Hydrochloride; Isosorbide Dinitrate
Location Trials
Georgia 2
Alabama 2
Massachusetts 2
Pennsylvania 2
Florida 2
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Clinical Trial Progress for Hydralazine Hydrochloride; Isosorbide Dinitrate

Clinical Trial Phase

Clinical Trial Phase for Hydralazine Hydrochloride; Isosorbide Dinitrate
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Hydralazine Hydrochloride; Isosorbide Dinitrate
Clinical Trial Phase Trials
Recruiting 3
Active, not recruiting 2
Completed 1
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Clinical Trial Sponsors for Hydralazine Hydrochloride; Isosorbide Dinitrate

Sponsor Name

Sponsor Name for Hydralazine Hydrochloride; Isosorbide Dinitrate
Sponsor Trials
Arbor Pharmaceuticals, Inc. 1
Henrik Wiggers 1
University of Cape Town 1
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Sponsor Type

Sponsor Type for Hydralazine Hydrochloride; Isosorbide Dinitrate
Sponsor Trials
Other 15
U.S. Fed 1
NIH 1
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