CLINICAL TRIALS PROFILE FOR HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

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	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.
NCT02305095 ↗	Genomic Response Analysis of Heart Failure Therapy in African Americans	Active, not recruiting	University of Pittsburgh		2015-05-01	The response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when compared to similar white cohorts. This study will seek to confirm the previous genetic sub-study from AHeFT which suggested a functional polymorphism of guanine nucleotide binding protein beta polypeptide 3 subunit (GNB3), C825T in exon 10, influences the therapeutic efficacy of FDC I/H. This study will initiate treatment with FDC I/H in 500 self designated African American subjects with systolic heart failure. They will be followed for up to two years on therapy. Clinical outcomes (survival, heart failure hospitalizations, and change in quality of life) on FDC I/H will be compared by GNB3 genotype subset. The hypothesis to be confirmed is that subjects homozygous for the T allele (those with the GNB3 TT genotype which is present in approximately 50% of black subjects) demonstrate enhanced therapeutic benefit from FDC I/H.

Clinical Trial Conditions for hydralazine hydrochloride; isosorbide dinitrate

Condition Name

Condition Name for hydralazine hydrochloride; isosorbide dinitrate
Intervention	Trials
Heart Failure	4
Cardio-Renal Syndrome	1
Chronic Hemodialysis (ESRD)	1
Congestive Heart Failure	1

Condition MeSH

Condition MeSH for hydralazine hydrochloride; isosorbide dinitrate
Intervention	Trials
Heart Failure	5
Syndrome	1
Cardio-Renal Syndrome	1
Kidney Failure, Chronic	1

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

Trials by US State

Trials by US State for hydralazine hydrochloride; isosorbide dinitrate
Location	Trials
Georgia	2
Florida	2
Alabama	2
Massachusetts	2
Pennsylvania	2

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

Clinical Trial Status

Clinical Trial Status for hydralazine hydrochloride; isosorbide dinitrate
Clinical Trial Phase	Trials
Completed	3
Unknown status	2
Active, not recruiting	1

Clinical Trial Sponsors for hydralazine hydrochloride; isosorbide dinitrate

Sponsor Name

Sponsor Name for hydralazine hydrochloride; isosorbide dinitrate
Sponsor	Trials
University of Pennsylvania	1
Danish Council for Independent Research	1
Corporal Michael J. Crescenz VA Medical Center	1

Sponsor Type

Sponsor Type for hydralazine hydrochloride; isosorbide dinitrate
Sponsor	Trials
Other	14
Industry	2
U.S. Fed	1