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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT02299960
Eligibility Criteria:
Inclusion Criteria:
* Clinically stable for the last 4 weeks (not for HFrEF: 7 days)
* Signed consent form
HFpEF:
* Baseline-Echocardiography:
* hospitalization \<= 12 months with diagnosis heart failure and E/E' \> 8 or E' \< 8 cm/s or
* BNP \>= 100pg/ml or NT-proBNP \>= 300pg/ml in the last 6 months or
* LAVI \> 28 ml/m² and E/E' \> 8 or E' \< 8cm/s or PAPsys \> 40mmHg and E/E' \> 8 or E' \< 8 cm/s
* Possibility to take part in cardiac stress test
* Heart failure NYHA I-III
* Sinus rhythm
* Max. O2-uptake on exertion \< 20ml/kgBW/min
HFrEF
* HFrEF due to ischemic or non-ischemic reasons
* NYHA I-III
* Individually optimized and stable pharmacological therapy (including beta-blocker, ACE-Inhibitor, AT1-antagonist, aldosterone-antagonist)
* EF \<=45%, Simpson Biplan PH
* NICE-Classification 2013 I/II
* PAH \>= 25 mmHg
* Precapillary PAH: Wedge-pressure \<= 15 mmHg, CO normal or low
* Postcapillary PAH: Wedge-pressure \>= 15 mmHg, CO normal or low
Diabetic nephropathy:
* Diabetes mellitus Type 2 with oral or Insulin therapy and one or more of the following:
* Diabetic nephropathy has been diagnosed before (anamnesis)
* Macroalbuminuria: Urine Albumine/Creatinine-ratio \> 300mg/g Creatinine (\>34mg/mmol) in 2 out of 3 tests of Urine in the morning and GFR \<90ml/min/1.73m² (CKD-EPI)
* Microalbuminuria: 30-300mg/g Creatinine (\>=3.4 mg/mmol but \<34mg/mmol) tested as above and GFR \< 90 ml/min/1.73m² and diabetic retinopathy
AH:
* Hypertension diagnosed at least 6 months except structural heart disease: EF \> 55% and no sign of HFpEF
* No symptoms of coronary heart disease
* Possibility to take part in cardiac stress test
* Stable pharmacologic therapy of Hypertension for at least 4 weeks
* Systolic blood pressure \<140 mmHG during Screening
Exclusion Criteria:
* Patient incapable of contracting
* Angina pectoris \> CCS II
* Coronary Intervention in the last 4 weeks or scheduled Intervention/Bypass
* Myocardial infarction in the last 3 months
* Stroke in the last 3 months
* Valvular heart disease \> II°
* Cardiomyopathy due to Infiltrate/hypertrophic obstruction (e.g. HOCM, Amyloidosis)
* Congenital complex heart disease
* Active myocarditis
* Significant lung disease
* Significant Cardiac dysrhythmia
* Scheduled changes in medication during time of study
* (Scheduled) heart transplant
* Cardiac resynchronisation therapy over the last three months
* ICD/Pacemaker-implant in the last 4 weeks
* Uncontrolled Hyper/Hypotension (\>180mmHg, \<95mmHg)
* Patient taking part in Rehabilitation program
* Diagnosed Malignant disease or disease with life expectancy \< 1 year
* Anemia with Hb\<10mg/dl
* Untreated significant thyroid disease
HFpEF, Hypertension and PH:
* Patient incapable of cardiac stress test (e.g. because of orthopedic Problems)
* Significant changes in cardiovascular Status over the two weeks of study
* Instable cardiopulmonary Status over the last four weeks
HFrEF:
* I.v. Treatment with inotropic drug or diuretic in the last 7 days before Screening
* Myocardial infarction in the last 4 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT02299960
Study Brief:
Protocol Section:
NCT02299960