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Effect of Isosorbide Mononitrate on Hypertension to Improve Left Ventricular Hypertrophy, Fibrosis and Myocardial Function | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Effect of Isosorbide Mononitrate on Hypertension to Improve Left Ventricular Hypertrophy, Fibrosis and Myocardial Function

Targeting Wave Reflections to Improve Left Ventricular Hypertrophy, Fibrosis and Myocardial Function in Hypertension

NCT01961453•Corporal Michael J. Crescenz VA Medical Center

View on ClinicalTrials.gov

Summary

The purpose of this research study is to test whether treatment with isosorbide mononitrate will improve left ventricular hypertrophy ("thickening") which puts people at risk for developing heart failure. Once it develops, heart failure is a very serious condition and thus it is important to find ways to prevent it from happening. The investigators have reasons to believe that dilating the blood vessels with this specific medication will improve the thickening of the heart, which increases the risk of heart failure.

Eligibility

Age

18 - 89 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Systolic blood pressure \>140 mmHg, diastolic blood pressure \> 90 mmHg.
•An elevated left ventricular mass index (defined as \>60 g/m1.7 in women and 80 g/m1.7 in men) OR LV posterior wall thickness \>1.4 cm documented in a clinically indicated echocardiographic examination or magnetic resonance imaging scan within the previous 12 months.
•Stable medical therapy as defined by: (1)No addition or removal of ACE inhibitors, angiotensin receptor blockers, beta-blockers, or calcium channel blockers for 30 days. (2)No change in dosage of ACE, angiotensin-receptor blocker, beta-blockers or calcium-channel blockers s of more than 100% for 30 days.
•Current therapy with an ACE inhibitor, hydralazine or a statin, all of which have been shown to reduce nitrate tolerance.

Exclusion Criteria

•Rhythm other than sinus rhythm (i.e., atrial fibrillation).
•Non-cardiac condition limiting life expectancy to less than one year, per physician judgment.
•Current or anticipated future need for nitrate therapy.
•Valve disease (\> mild aortic or mitral stenosis; \> moderate aortic or mitral regurgitation).
•Hypertrophic cardiomyopathy.
•Known infiltrative or inflammatory myocardial disease (amyloid, sarcoid).
•Pericardial disease.
•Primary pulmonary arteriopathy.
•Have experienced a myocardial infarction or unstable angina, or have undergone percutaneous transluminal coronary angiography (PTCA) or coronary artery bypass grafting (CABG) within 60 days prior to consent, or requires either PTCA or CABG at the time of consent.
•Resting heart rate (HR) \> 100 bpm.
+8 more criteria

Locations (1)

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

August 1, 2013

Primary Completion Date

January 1, 2016

Completion Date

January 1, 2016

Last Updated

August 11, 2016

Conditions

Hypertension

Interventions

Isosorbide Mononitrate, sustained release

DRUG

Placebo capsule

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 11, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effect of Isosorbide Mononitrate on Hypertension to Improve Left Ventricular Hypertrophy, Fibrosis and Myocardial Function

Inclusion Criteria

Exclusion Criteria

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