Heart and Blood Diseases

All Conditions

Heart Failure

Heart Diseases

Antihypertensive Agents

All Drugs and Chemicals

Vasoconstrictor Agents

Valsartan

Sacubitril and valsartan sodium hydrate drug combination

Angiotensin II

Giapreza

Angiotensinogen

Angiotensin II Type 1 Receptor Blockers

Angiotensin Receptor Antagonists

Sacubitril-valsartan administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).

Valsartan administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)

Administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).

Sacubitril-valsartan

Administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)

Massey Cancer Control DWG

Massey CTO Operations Managers

Massey CPC DWG

Wendy Bottinor, MD

To determine feasibility of recruitment and tolerability of treatment with sacubitril-valsartan among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.

The current study will test the hypothesis that among adult age survivors of cancer diagnosed at age \< 39 years treatment of Stage B heart failure with sacubitril-valsartan is feasible and safe.

Cardiac magnetic resonance studies will be de-identified and assigned a study number. The identification key will not be available to cardiac magnetic resonance readers so that they are blinded to treatment allocation

Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan

Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan (Treat HF)

There are no plans to make individual participant data available to other researchers at this time.

Number of participants screened for the clinical trial.

Number of participants enrolled on the trial

Number of participants that complete therapy

Number of deaths while on study due to cardiac event

Number of deaths while on study due to non-cardiac events

By the number of Adverse events at 30 days

By the number of Adverse events at 60 days

By the number of Adverse events at 90 days

By determining number of participants with interval change utilizing a 6-minute walk test distance

By number of participants with cardiovascular magnetic resonance imaging assessment change in cardiac fibrosis burden.

By number of participants with cardiovascular magnetic resonance imaging assessment change in microvascular perfusion.

By number of participants with cardiovascular magnetic resonance imaging assessment change in arterial stiffness/4D flow.

By number of participants with cardiovascular magnetic resonance imaging assessment change in left ventricular ejection fraction.

By number of participants with cardiovascular magnetic resonance imaging assessment change in change in left ventricular strain.

Virginia Commonwealth University

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Autoimmune Diseases

Kidney Diseases

Necrosis

Nephritis

Proteinuria

Glomerulonephritis, IGA

Urologic Diseases

Glomerulonephritis

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urination Disorders

Urological Manifestations

IgA Nephropathy

Anti-Infective Agents

Antirheumatic Agents

Antineoplastic Agents

Hydroxychloroquine

Interferons

Enzyme Inhibitors

Interferon-alpha

Antiparasitic Agents

Antimalarials

Immunoglobulin A

Antiprotozoal Agents

valsartan (160mg/d) and Hydroxychloroquine Sulfate ( 400mg/d, twice daily)

Hydroxychloroquine Sulfate

RUITONG GAO, MD

Ruitong Gao, MD

Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis in the world.There is to date no curative therapy for patients with IgAN.It is considered that dendritic cells, Toll-like receptor (TLR) 9 and cytokines interleukin-6 (IL-6), and interferon-alpha (IFN-a) and tumor necrosis factor-alpha (TNF-α), play an important role in the aberrant mucosal response. Hydroxychloroquine is an antimalarial agent and had a notable impact on immune activation by the reduction of circulating activated immune cells that including decreased TLR-expressing cells, reduced IFN-secreting plasmacytoid dendritic cells, reduced production of inflammatory cytokines including interferon alpha, IL-6 and TNF alpha. Recent studies showed hydroxychloroquine had a benefit for renal remission and could retard the onset of renal damage in patients with lupus nephritis. hydroxychloroquine may have the potential effect in IgA nephropathy, alleviated the proteinuria and had the renal protect effect. This will be a single center, prospective, randomized, controlled study to assess the utility of hydroxychloroquine in IgAN patients.

Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis in the world. Its estimated frequency is at least 2.5 cases per year per 100,000 adults. The glomerulopathy usually progressed slowly leading to end stage renal disease (ESRD). ESRD developed in 20%-40% of patients after 20 years. Given its complex and as yet incompletely understood pathogenetic mechanisms, there is to date no curative therapy for patients with IgAN.

Although pathogenesis of IgAN is still obscure, underglycosylated IgA-containing immune-complex including IgG or IgA antibodies against the hinge region of IgA1 are key factors for IgA nephropathy. Aberrant mucosal immune response might lead to increased production of underglycosylated IgA1. It is considered that dendritic cells, Toll-like receptor (TLR)9, and cytokines interleukin-6 (IL-6), , interferon-alpha (IFN-a) and tumor necrosis factor-alpha (TNF-α), play an important role in the aberrant mucosal response.

Hydroxychloroquine is an antimalarial agent and had a notable impact on immune activation by the reduction of circulating activated immune cells that including decreased TLR-expressing cells, reduced IFN-secreting plasmacytoid dendritic cells, reduced production of inflammatory cytokines including interferon alpha, IL-6 and TNF alpha. Recent studies showed hydroxychloroquine had a benefit for renal remission and could retard the onset of renal damage in patients with lupus nephritis.

Therefore, hydroxychloroquine, targeting dendritic cells, TLR, IL-6, IFN-α and TNF-α，may have the potential effect in IgA nephropathy, alleviated the proteinuria and had the renal protect effect. This will be a single center, prospective, randomized, controlled study to assess the utility of hydroxychloroquine added to valsartan in IgAN patients.

Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy

Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy:a Single Center Prospective Randomized Controlled Study

CR: proteinuria \<0.3 g/24 hr with no worsening of renal function (\<15% estimated glomerular filtration rate(eGFR) reduction from Baseline).PR: proteinuria \<3.5g/24 hrs but ≥0.3g/24 hrs and a decrease of \>50% from Baseline based on 24 hours pooled urine, with no worsening of renal function(\<15% eGFR reduction from Baseline). eGFR at Baseline will be defined as the Day 0 values.

Proteinuria is being assessed at Weeks 0, 4, 12, 24 follow-up visits. Proteinuria is based on 24 hours pooled urine. Baseline is defined as the Day 0 values. The ratio is defined as the post-Baseline value divided by the Baseline value.

Serum creatinine is being assessed at Weeks 0, 4, 12, 24 follow-up visits. Baseline is defined as the Day 0 values. The ratio is defined as the post-Baseline value divided by the Baseline value.

eGFR is being assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by national kidney foundation-chronic kidney disease (NKF-CKD) guidelines. eGFR is calculated at Weeks 0, 4, 12, 24 follow-up visits. Baseline is defined as the Day 0 values. The ratio is defined as the post-Baseline value divided by the Baseline value.

IgA levels in serum are being analyzed at Weeks 0, 4, 12, 24 follow-up visits. Baseline is defined as the Day 0 value. The ratio is defined as the post-Baseline value divided by the Baseline value.

Interleukin-6 levels in serum are being analyzed at Weeks 0, 4, 12, 24 follow-up visits by means of enzyme linked immunosorbent assay (ELISA). Baseline is defined as the Day 0 value. The ratio is defined as the post-Baseline value divided by the Baseline value.

Interferon alfa levels in serum are being analyzed at Weeks 0, 4, 12, 24 follow-up visits by means of enzyme linked immunosorbent assay (ELISA). Baseline is defined as the Day 0 value. The ratio is defined as the post-Baseline value divided by the Baseline value.

Tumor necrosis factor alpha levels in serum are being analyzed at Weeks 0, 4, 12, 24 follow-up visits by means of enzyme linked immunosorbent assay (ELISA). Baseline is defined as the Day 0 value. The ratio is defined as the post-Baseline value divided by the Baseline value.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan	NCT05194111	Heart Failure Heart Dysfuncti...	Sacubitril-vals... Valsartan	18 Years - 120 Years	Virginia Commonwealth University
Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan	NCT05194111	Heart Failure Heart Dysfuncti...	Sacubitril-vals... Valsartan	18 Years - 120 Years	Virginia Commonwealth University
Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy	NCT02765594	Primary IgA Nep...	Hydroxychloroqu... Valsartan	18 Years - 60 Years	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for valsartan

Every month we try and update this database with for valsartan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for valsartan

Every month we try and update this database with for valsartan cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for valsartan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.