Targeting Central Pulsatile Hemodynamics in Chronic Kidney Disease (NCT02791906) | Clinical Trial Compass
TerminatedPhase 2
Targeting Central Pulsatile Hemodynamics in Chronic Kidney Disease
Stopped: lack of funding
United States8 participantsStarted 2016-05
Plain-language summary
Heart failure (HF) is an epidemic and is a major burden on the US healthcare system. The most common cardiovascular endpoint is HF. Thus, novel interventions to prevent HF in chronic kidney disease (CKD) are highly desirable. This study will assess: the variability in the response to isosorbide mononitrate (ISMN) therapy; the degree of change in central hemodynamics and cardiac endpoints through analysis of changes in left ventricle (LV) mass, diffuse myocardial fibrosis, and myocardial systolic and diastolic function.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Chronic kidney disease stage 3
* Elevated left ventricular mass index or LV posterior wall thickness \>1.4 cm documented in a clinically indicated echocardiographic or MRI examination within the previous 24 months or electrocardiographic LV hypertrophy
* Stable medical therapy as defined by no addition, removal or change in dosage \>100% of Angiotensin-converting-enzyme (ACE) inhibitors, angiotensin receptor blockers, beta-blockers, or calcium channel blockers 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:
* A clinically- indicated stress test demonstrating significant myocardial ischemia within 1 year of enrollment, not followed by coronary revascularization
* Rhythm other than sinus (i.e., atrial fibrillation)
* Non-cardiac condition limiting life expectancy to \<1 year
* Current or anticipated future need for long acting organic nitrate therapy
* Severe aortic or mitral valve disease
* Hypertrophic cardiomyopathy
* Known infiltrative or inflammatory myocardial disease (amyloid, sarcoid)
* Pericardial disease
* Primary pulmonary arteriopathy
* History of myocardial infarction, unstable angina, percutaneous transluminal coronary angiography (PTCA) or coronary artery bypass grafting (CABG) within 60 days, or requirement for either PTCA or CABG at the time of consent
* Resting heart rate (HR) \>100 bpm
* A reduced LV ejection fraction (EF\<50%…
What they're measuring
1
Change in LV Mass
Timeframe: Measured at Baseline Visit and 24 Week Visit