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Table 1 Inclusion and exclusion criteria

From: A novel integrated care concept (NICC) versus standard care in the treatment of chronic cardiovascular diseases: protocol for the randomized controlled trial CardioCare MV

Inclusion criteria:

 • Heart failure (ICD code I50, NYHA II–IV) or atrial fibrillation (I48, EHRA II–IV) or therapy-resistant hypertension (I10–15 mmHg, ≥ 3 antihypertensives from different drug classes, SBP > 140/90 mmHg or ≥ 4 antihypertensives irrespective of the blood pressure, with at least one drug being a diuretic)

 • Member of health insurance company Allgemeine Ortskrankenkasse (AOK) Nordost or Techniker Krankenkasse (TK). This is required because patients of the NICC group need to sign an integrated care contract with their health insurance company to allow for legitimate roll-out of intersectoral care delivery model NICC according to German social law

 • Residence in Mecklenburg-Vorpommern

 • Age ≥ 18 years

 • Written informed consent

Exclusion criteria:

 • Pregnancy, suspected pregnancy, or breast-feeding period

 • Participation in another clinical trial up to 30 days before inclusion in this trial

 • Cognitive deficits: patients need to be able to read and understand the German language as presented on a tablet

 • Chronic kidney disease requiring dialysis or creatinine clearance < 15 ml/min

  1. ICD International Classification of Diseases, EHRA European Heart Rhythm Association, NYHA New York Heart Association, NICC novel integrated care concept, SBP systolic blood pressure
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Trials

ISSN: 1745-6215