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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT00207220
Eligibility Criteria:
Inclusion Criteria:
Subjects with heart failure and preserved ejection fraction
* clinical signs of heart failure
* serum brain natriuretic peptide (BNP) \>100pg/mL
* NYHA functional class II-IV
* left ventricular ejection fraction(LVEF) \>=50% measured by echocardiography
* Non-diabetic subjects with hypertension
* treated or untreated essential hypertension
* LVEF \>=50% measured by echocardiography
Diabetic subjects with hypertension
* Type 2 diabetes
* treated or untreated essential hypertension
* LVEF \>=50% measured by echocardiography
Normotensive control subjects
* normal blood pressure (i.e. \< 140/90 mmHg)
* LVEF \>=50% measured by echocardiography
Exclusion Criteria:
Subjects with heart failure and preserved ejection fraction
* atrial fibrillation
* symptoms of angina or a myocardial infarction (MI) within 6 months
* known significant coronary artery disease (CAD) (stenosis \> 70%)
* significant valvular heart disease
* restrictive/constrictive heart disease
* inability to lie flat for procedure (estimated duration 1 hour)
Non-diabetic subjects with hypertension
* atrial fibrillation
* symptoms of angina or a myocardial infarction (MI) within 6 months
* known significant coronary artery disease (CAD) (stenosis \> 70%)
* significant valvular heart disease
* restrictive/constrictive heart disease
* inability to lie flat for procedure (estimated duration 1 hour)
* prior history of heart failure or unexplained dyspnea
Diabetic subjects with hypertension
* atrial fibrillation
* symptoms of angina or a myocardial infarction (MI) within 6 months
* known significant coronary artery disease (CAD) (stenosis \> 70%)
* significant valvular heart disease
* restrictive/constrictive heart disease
* inability to lie flat for procedure (estimated duration 1 hour)
* prior history of heart failure or unexplained dyspnea
Normotensive control subjects
* prior history of structural heart disease or ventricular hypertrophy
* treatment with HMG-Co(A)reductase inhibitors (statins)
* anti-hypertensive medications
* cigarette smoking
* cocaine use
* excessive alcohol intake
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00207220
Study Brief:
Protocol Section:
NCT00207220