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Valsartan

Clinical trials investigating Valsartan are studying how it may help in different heart and blood vessel conditions, and in some studies how it compares with other treatments. These trials look at safety, effectiveness, and clinical outcomes in groups such as people with heart failure, cardiomyopathy, diabetes, children and young adults with Marfan syndrome, and kidney transplant recipients.

Table of contents

Clinical trials overview

The trial data shows that Valsartan is being studied in a wide range of clinical settings, mostly in heart disease and blood vessel disease. These studies include both direct Valsartan trials and trials where Valsartan is part of a combination treatment such as sacubitril/valsartan.[1][2]

The studies are in different stages, including Phase 1, Phase 2, and Phase 3, plus some low-intervention trials. This means the research ranges from early testing in healthy volunteers to larger patient studies that measure real health outcomes.[3][4]

Heart failure and related heart studies

Most of the listed trials focus on heart failure, which is when the heart does not pump blood as well as it should. Several studies look at whether Valsartan, alone or in combination, can help prevent worsening heart function or reduce later heart failure events.[5][6]

One authorised Phase 3 study in people with diabetes mellitus type 2 is testing whether high-dose treatment with RAS-antagonists and beta-blockers can reduce cardiac death or cardiac hospitalisation. Valsartan 320 mg is one of the study drugs, and the trial uses a combined endpoint based on the first cardiac death or cardiac hospitalisation.[7]

Another Phase 2 heart failure study is testing XXB750 in symptomatic patients with LVEF below 50%, while patients receive standard care that may include ACE inhibitors, ARBs, or sacubitril/valsartan. The main outcome is the change in log NT-proBNP from baseline to Week 16.[4]

A Phase 3 study in ischemic heart failure with mid-range ejection fraction compares sacubitril/valsartan with ramipril and measures the change in left ventricular end-systolic volume after 12 months by MRI. This helps researchers see whether treatment changes heart size and shape over time.[5]

Another authorised Phase 3 study looks at pharmacological optimisation in heart failure and includes Valsartan among many treatment options. It has both a retrospective part, which studies current prescribing patterns and sex differences, and a prospective part, which measures mortality, heart failure readmission, quality of life, adherence, and side effects.[6]

Several other heart failure trials study withdrawal, continuation, or timing of treatment in patients who improved after cardiac resynchronisation therapy or who have recovered left ventricular function. In these studies, Valsartan appears in the treatment lists, and the main concern is whether stopping or changing therapy leads to relapse of cardiomyopathy or heart failure.[1][8]

One completed Phase 3 trial compared sacubitril/valsartan with enalapril in patients with heart failure with reduced ejection fraction and pulmonary hypertension. The main outcomes were changes in mean pulmonary artery pressure and pulmonary vascular resistance, which are measures of pressure and resistance in the lung circulation.[9]

Another completed Phase 3 trial in heart failure with preserved ejection fraction and secondary mitral valve regurgitation studied sacubitril/valsartan and measured the slope of mPAP/CO during exercise testing. Secondary outcomes included valve measurements and quality of life.[10]

There is also an authorised Phase 3 trial in heart failure with recovered ejection fraction that studies whether stopping beta-blockers is non-inferior to continuing them. Valsartan appears in the intervention list, and the primary endpoint is a composite of heart failure relapse and other adverse cardiovascular outcomes during follow-up.[11]

Marfan syndrome and aortic disease

One authorised Phase 3 trial studies Marfan syndrome and related inherited aortic diseases in children and young adults. The goal is to see whether Valsartan can slow the widening of the aortic root, which is the first part of the aorta coming out of the heart.[12]

The primary outcome in this study is the annual change in aortic diameter measured by transthoracic echocardiography, which is an ultrasound scan of the heart. This is a direct way to track whether the aorta grows more slowly over time.[12]

Another Phase 3 trial in arrhythmogenic cardiomyopathy studies sacubitril/valsartan and looks at left ventricular fibrosis, left ventricular ejection fraction, and ventricular arrhythmia burden. Although this study uses the combination treatment, it still belongs to the wider group of Valsartan-related trials in the dataset.[13]

Kidney transplant study

One authorised Phase 3 study is in renal transplant patients with signs of post-transplant glomerulopathy. It tests whether Valsartan can help prevent a drop in glomerular filtration, which is a measure of kidney filtering function.[14]

This trial does not list a primary endpoint in the source data, but its brief summary makes the research aim clear: to see whether an ARB can help protect kidney function in a specific transplant subgroup with urinary PECs.[14]

Healthy volunteer bioequivalence studies

Two completed Phase 1 studies enrolled healthy volunteers to compare two formulations of sacubitril/valsartan. These studies were designed to show bioequivalence, meaning the test product and reference product behave similarly in the body.[2][15]

The main outcomes were sacubitril and Valsartan blood exposure measures, including AUC0-t and Cmax. These measures help researchers compare how much medicine gets into the blood and how high the blood level becomes after dosing.[2][15]

Main endpoints used in the trials

The trials use many different endpoints, but several are repeated across studies. Common heart outcomes include changes in left ventricular ejection fraction, left ventricular volume, heart failure relapse, and hospitalisation for heart failure or cardiac causes.[5][5][1]

Some studies focus on blood markers such as NT-proBNP, which can reflect how much strain is placed on the heart. Others use imaging tests like MRI, echocardiography, or stress testing to measure heart structure and function more directly.[4][10]

In the Marfan study, the main endpoint is the yearly change in aortic diameter. In the kidney transplant study, the goal is to protect glomerular filtration. In the bioequivalence studies, the main endpoints are AUC and Cmax for sacubitril and Valsartan.[12][14][2]

Who can participate

Participation depends on the study question. The trials include healthy volunteers, adults with heart failure, people with diabetes and no known heart disease, patients with cardiomyopathy, children and young adults with Marfan-related disease, and kidney transplant recipients.[1][7][12][14]

Some studies are looking for people with recovered heart function, while others focus on patients with active symptoms or special heart conditions such as pulmonary hypertension or mitral valve regurgitation. This shows that Valsartan-related research is aimed at very different patient groups, not just one disease.[1][9][10]

Trial ID Phase Condition studied Status Enrollment
2025-521780-12-00Low InterventionNon-ischemic cardiomyopathyAuthorised64
2022-503083-32-00Phase 1Healthy volunteersCompleted36
NCT02817360Phase 3Diabetes mellitus Type 2Authorised889
2023-504678-39-00Phase 2Heart FailureCompleted740
NCT05508035Phase 3heart failure with moderately reduced ejection fraction (HFmrEF)Authorised666
2025-520660-18-00Phase 3Heart FailureAuthorised368
2024-517804-12-00Phase 3Heart failure – post-anthracycline cardiomyopathyAuthorised600
2024-517975-19-00Phase 3Heart Failure with reduced ejection fractionCompleted32
2023-506634-70-00Phase 3Heart failure with preserved ejection fraction; Secondary mitral valve regurgitationCompleted110
NCT05989503Low InterventionHeart failure with reduced ejection fractionCompleted172
2022-503135-33-00Phase 3Subclinical heart failureAuthorised130
2023-504946-70-00Phase 3Heart FailureAuthorised60
2023-505237-27-00Phase 1Healthy volunteersCompleted36
2024-515059-39-00Phase 3Marfan Syndrome and related aortic diseasesAuthorised180
2024-518723-30-01Phase 3Renal transplant patientsAuthorised180

FAQ

  • Who can join clinical trials investigating Valsartan? It depends on the study. Some trials include people with heart failure, cardiomyopathy, diabetes, Marfan syndrome, kidney transplant problems, or hypertrophic cardiomyopathy. Other trials include healthy volunteers for bioequivalence testing.
  • What are these Valsartan trials trying to find out? The trials are testing different research questions, such as whether Valsartan helps prevent disease progression, improves heart function, or changes blood vessel or kidney outcomes. Some studies also compare Valsartan with other treatments or with placebo.
  • Are all Valsartan studies in the same phase? No. The trials include Phase 1, Phase 2, and Phase 3 studies, as well as some low-intervention studies. This means the research is at different stages, from early testing to larger studies in patients.
  • What kinds of conditions are being studied with Valsartan? The trial data includes non-ischemic cardiomyopathy, heart failure, heart failure with reduced or mid-range ejection fraction, subclinical heart failure, Marfan syndrome, transthyretin cardiac amyloidosis, renal transplant recipients, and hypertrophic cardiomyopathy.
  • What outcomes do these trials measure? Common outcomes include changes in left ventricular ejection fraction, left ventricular volume, NT-proBNP, heart failure relapse, cardiac hospitalization, aortic root growth, pulmonary artery pressure, and kidney function measures. Some trials also measure bioequivalence using blood level measures like AUC and Cmax.

Ongoing Clinical Trials on Valsartan

  • Study on Valsartan for Kidney Transplant Patients with Post-Transplant Glomerulopathy

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Heart failure: A condition where the heart does not pump as well as it should. The trials study this in several forms, including reduced, mid-range, preserved, and subclinical heart failure.
  • Left ventricular ejection fraction (LVEF): A measure of how much blood the left side of the heart pumps out with each beat. Several trials use changes in LVEF as a main outcome.
  • Left ventricular end-systolic volume: The amount of blood left in the left ventricle after the heart contracts. A rise in this value can show worsening heart function.
  • NT-proBNP: A blood marker that can rise when the heart is under stress. Some trials use it to track worsening heart failure or treatment effect.
  • Magnetic resonance imaging (MRI): A scan that gives detailed pictures of the heart. Some trials use MRI to measure heart size, volume, or remodeling.
  • Cardiac remodeling: Changes in the size, shape, or structure of the heart. Trials in heart failure and Marfan syndrome look at whether treatment can improve or slow these changes.
  • Bioequivalence: A comparison showing that two medicines behave similarly in the body. Two Phase 1 studies tested two formulations of sacubitril/valsartan in healthy volunteers.
  • AUC: A blood test measure of total drug exposure over time. It is used in bioequivalence studies.
  • Cmax: The highest blood level reached after a dose. It is also used in bioequivalence studies.
  • Pulmonary artery pressure: The pressure in the blood vessels that carry blood from the heart to the lungs. One study measured whether treatment lowered this pressure.
  • Glomerular filtration: A measure of how well the kidneys filter blood. One trial in kidney transplant recipients looked at whether Valsartan could help prevent a drop in this function.
  • Placebo: An inactive treatment used for comparison in a trial. It helps researchers see whether the study drug works better than no active treatment.

References

  1. https://clinicaltrials.gov/study/2025-521780-12-00
  2. https://clinicaltrials.gov/study/2022-503083-32-00
  3. https://clinicaltrials.eu/trial/study-on-preventing-heart-disease-in-diabetes-patients-using-eprosartan-mesilate-and-drug-combination/
  4. https://clinicaltrials.gov/study/2023-504678-39-00
  5. https://clinicaltrials.eu/trial/study-on-the-effects-of-sacubitril-valsartan-and-ramipril-on-heart-function-in-patients-with-ischemic-heart-failure-with-mid-range-ejection-fraction/
  6. https://clinicaltrials.gov/study/2025-520660-18-00
  7. https://clinicaltrials.gov/study/2024-517804-12-00
  8. https://clinicaltrials.gov/study/2023-504946-70-00
  9. https://clinicaltrials.gov/study/2024-517975-19-00
  10. https://clinicaltrials.gov/study/2023-506634-70-00
  11. https://clinicaltrials.gov/study/2023-508798-94-00
  12. https://clinicaltrials.gov/study/2024-515059-39-00
  13. https://clinicaltrials.gov/study/2024-517412-29-00
  14. https://clinicaltrials.gov/study/2024-518723-30-01
  15. https://clinicaltrials.gov/study/2023-505237-27-00