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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT01091467
Eligibility Criteria:
Inclusion Criteria:
* Patient presenting to the hospital with congestive heart failure, defined as:
1. Clinical signs of heart failure
Major criteria
* Paroxysmal nocturnal dyspnea
* Orthopnea
* Jugular venous distension
* Pulmonary crackling rales
* 3rd heart sound
* Cardiothoracic ratio \> 0.5 on X-ray
* Pulmonary oedema on X-ray
Minor Criteria
* peripheral oedema
* nocturnal cough
* dyspnoea at exercise
* hepatomegaly
* pleural effusion
* tachycardia (defined as ≥ 100 beats per minute)
Heart failure if: presence of 2 major criteria or 1 major + 2 minor criteria
2. LVEF ≥ 45% by echocardiography within 72h
3. BNP \> 100 ng/L or NT-proBNP \> 300 ng/L
Exclusion Criteria:
* Evidence of primary hypertrophic or restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease
* Known cause of right heart failure not related to left ventricular dysfunction
* Pericardial constriction
* Clinically significant pulmonary disease, as evidenced by requirement of home oxygen.
* End-stage renal disease requiring dialysis
* Bi-ventricular pacemaker (CRT)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01091467
Study Brief:
Protocol Section:
NCT01091467