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Last Updated: November 22, 2024

CLINICAL TRIALS PROFILE FOR ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE


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All Clinical Trials for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01516346 ↗ Vasodilator Therapy for Heart Failure and Preserved Ejection Fraction Completed 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 Completed 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 Completed 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 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.
NCT02228408 ↗ Safety and Cardiovascular Efficacy of Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD Completed Brigham and Women's Hospital Phase 4 2017-08-28 This study is a pilot study designed to compare the safety and cardiovascular effects of 26 weeks of combination hydralazine/isorsorbide dinitrate therapy with placebo therapy in patients receiving chronic hemodialysis. The investigators hypothesize that treatment of chronic hemodialysis (ESRD) patients with a combination of hydralazine/isosorbide dinitrate compared with placebo is safe and that it will improve heart function as well blood flow/blood vessel supply.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE

Condition Name

Condition Name for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
Intervention Trials
Heart Failure 4
Acute Heart Failure 1
Cardio-Renal Syndrome 1
Chronic Hemodialysis (ESRD) 1
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Condition MeSH

Condition MeSH for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
Intervention Trials
Heart Failure 5
Cardio-Renal Syndrome 1
Kidney Failure, Chronic 1
Ventricular Dysfunction, Left 1
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Clinical Trial Locations for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE

Trials by Country

Trials by Country for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
Location Trials
United States 22
Denmark 1
Singapore 1
South Africa 1
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Trials by US State

Trials by US State for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
Location Trials
Massachusetts 2
Pennsylvania 2
Georgia 2
Florida 2
Alabama 2
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Clinical Trial Progress for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 3
Unknown status 2
Active, not recruiting 1
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Clinical Trial Sponsors for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
Sponsor Trials
University of Cape Town 1
The Danish Regions: Foundation for Medical Research 1
Brigham and Women's Hospital 1
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Sponsor Type

Sponsor Type for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
Sponsor Trials
Other 14
Industry 2
U.S. Fed 1
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