Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT00982033
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥ 55 years of age
* Symptomatic HFNEF of at least 1 month duration.
* Reduced early diastolic mitral annular velocity by tissue Doppler
* Left ventricular ejection fraction (LVEF ≥ 0.50)
* Baseline exercise intolerance
* Patients who are able to provide written informed consent
* Stable medical therapy for 30 days prior to screening
Exclusion Criteria:
* Seated blood pressure ≥ 160/90 mmHg at Visit 1 (screening)
* Clinically significant pulmonary disease
* Known history of documented EF \< 0.45 at any time
* Clinically unstable heart failure, medication changes for worsening heart failure symptoms within the past 4 weeks
* Severe anemia (Hgb \<10 mg/dL)
* Clinical evidence of uncontrolled hypo or hyperthyroidism
* Clinically significant valvular heart disease
* Surgical correction of valvular heart disease within the last year
* Known familial hypertrophic cardiomyopathy or hypertrophic obstructive cardiomyopathy
* Known restrictive cardiomyopathy or systemic illness known to be associated with infiltrative myocardial disease (e.g. amyloidosis, sarcoidosis, hemachromatosis)
* Pericardial restriction or hemodynamically significant pericardial effusion
* Cor pulmonal or other causes of right heart failure not related to LV dysfunction
* Extreme obesity (weight \> 325 pounds)
* Acute coronary syndrome within past 3 months
* Coronary artery revascularization within past 3 months
* Peripheral artery revascularization within past 3 months
* Acute cerebrovascular syndrome (stroke or TIA) within the past 3 months
* Uncontrolled symptomatic brady- or tachyarrhythmia
* Creatinine \> 2.5 mg/dl at screening
* Potassium \> 5.2 meq/l at screening
* Prior treatment with, hypersensitivity to, intolerance of or contra-indication to aliskiren
* Current treatment with antidepressant medication in the MAO(Monoamine Oxidase) inhibitor or SSRI(Selective serotonin reuptake inhibitors) class
* Current participation in another clinical trial
* Current treatment with both an ACE(Angiotensin-converting enzyme) inhibitor and an angiotensin receptor antagonist.
* Known significant bilateral renal artery stenosis
* Serious non-cardiovascular disease severely limiting life expectancy
* Previous major organ (e.g., lung, liver, heart, kidney) transplantation or on a transplant waiting list
* Any condition that is likely to prevent the patient from complying with the requirements of the study or completing the study (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no permanent home)
* Pregnant women, nursing women, and women of childbearing potential.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT00982033
Study Brief:
Protocol Section:
NCT00982033