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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT03186833
Eligibility Criteria:
Inclusion Criteria:
* Group A: males or females aged \> 70 years without major systemic comorbidities (resting blood pressure \<140/90 mmHg, no history diabetes mellitus according to WHO criteria).
* Group B: males or females aged \>70 years with hypertension, defined as a documented blood pressure of Systolic Blood Pressure (SP \>140 mmHg or \>90mmHg Diastolic Blood Pressure) without diabetes mellitus and HF defined as: a) relevant symptoms/signs/radiographic findings as indicated by Boston criteria b) need for diuretic therapy.
* Group C: male or female aged \> 70 years with diabetes mellitus (defined according to the World Health Organization (WHO)) AND hypertension, without HF defined as: a) relevant symptoms/signs/radiographic findings as indicated by Boston criteria38 b) need for diuretic therapy.
* Group D: male or female aged \>70 years with HFPEF, defined as signs and symptoms of HF with LVEF\>50% and raised natriuretic peptides (BNP\>35pg/ml or NT-proBNP\>125pg/ml) along with one other criteria: i) structural heart disease (left atrial enlargement or left ventricular hypertrophy) on TTE, ii) evidence of LV diastolic dysfunction based on ESC Guidelines 2016, or iii) hospitalization with heart failure within 12 months prior to study entry.
* Group E (parallel group): male or female aged \>70 years with HFREF, defined as HF with LVEF \<40% on TTE)
Exclusion Criteria:
* Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months, or urgent percutaneous coronary intervention (PCI) within 30 days of entry.
* Patients who have had an MI, coronary artery bypass graft (CABG) or other event within the 6 months prior to entry unless an echo measurement performed after the event confirms a LVEF ≥50%.
* Current acute decompensated HF requiring intravenous therapy
* Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, haemoglobin (Hb) \<10 g/dl, or body mass index (BMI) \> 40 kg/m2.
* Severe left-sided valvular heart disease
* Hypotension (systolic BP \<100 mm Hg).
* Severe Liver failure
* Primary pulmonary hypertension
* Bedbound/immobile patients
* Chronic renal failure with creatinine of \>250 μmol/l
* Significant Peripheral Vascular Disease (PVD), defined as having signs of absent peripheral pulses or reported claudication pain or documented history of PVD
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT03186833
Study Brief:
Protocol Section:
NCT03186833