Information about the Registry

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ABPM ON HFPEF GLOBAL REGISTRY is a prospective observational cohort study, international and multicentre. This study is auspice by Sociedad Española de Medicina Interna (SEMI), Sociedad Interamericana de Cardiología (SIAC) and Korean Society of Hypertension (KSH). The objectives of the Registry are:

Primary Objective

To identify hemodynamic biomarkers of blood pressure measured by ABPM with influence on the composite of hospital readmission due to HF, CV and non CV death or functional decline in patients with HF-PEF. The hemodynamic biomarkers included will be Dipping pattern, nocturnal hypertension, morning surge, differences between home and office BP (Masked Hypertension, Isolated clinical hypertension, uncontrolled hypertension and controlled hypertension), BP variability and its relation to outcomes, BP load and rate–pressure product.

Secondary Objectives

• To identify hemodynamic biomarkers of BP measured by ABPM with influence on hospital readmission in patients with HF-PEF.
• To identify hemodynamic biomarkers of Blood pressure measured by ABPM with influence on CV and non CV death in patients with HF-PEF.
• To identify hemodynamic biomarkers of Blood pressure measured by ABPM with influence on functional decline in patients with HF-PEF.
• To identify regional differences on the characteristics of HFPEF.
• To identify hemodynamic biomarkers of BP measured by ABPM with influence on cognitive impairment and frailty.

Patient entry criteria

Inclusion Criteria:

• Patients with a previous diagnosis of HF-PEF, defined by:
  • At least a previous hospitalization due to heart failure
  • Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch, or within 6 months prior to study entry.
  • Symptom(s) of heart failure (HF) and requiring, at least 30 days prior to study entry, hospitalization, or consultation to emergency room.
  • Current symptom(s) of HF.
  • Structural heart disease documented by echocardiogram, namely septal or posterior wall thickness >=1.1 cm) or LA enlargement (i.e., width >=3.8 cm, length >=5.0 cm, area >=20 cm2, volume >=55 ml, or volume index >=29 ml/m.
  • Elevated NT-proBNP defined as NT-proBNP >200 pg/ml if the patient had been hospitalized for HF within the past 9 months or >300 pg/ml if not so.

• Clinical and hemodynamic stability for at least 4 weeks before study inclusion, defined as stable treatment or functional class for at least 4 weeks before study inclusion, (changes in diuretic dosification are not considered as unstable treatment).

Exclusion Criteria:

• Any prior measurement of LVEF ≤ 40%.
• Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months, urgent percutaneous coronary intervention or limb amputation due to peripheral arterial disease or Stroke within 3 months or/and elective PCI within 30 days prior to entry.
• Current acute decompensated HF requiring therapy.
• Changes in antihypertensive treatment (class type or dose) 4 weeks before inclusion, excluding changes in diuretics due to congestion.
• Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, haemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2.
• Systolic blood pressure (SBP) ≥ 180 mmHg or DBP ≥ 110 mmHg at entry.
• Patients with severe chronic renal disease, defined as GFR <15 ml/min or haemodialysis.
• Inability to understand the study and participate voluntarily.
• Patients diagnosed with cancer in the previous 12 months, and requiring treatment, at the time of study inclusion.
• Patients diagnosed with systemic autoimmune disease (lupus, vasculitis...)
• Patients not able to perform an ambulatory blood pressure measurement namely working at night, or patients with tachyarrhythmia.

How to participate in the Registry

If you wish to be a Member of the Registry, or wish to receive additional information, you may contact with the CRO ABPM on HFPEF Global Registry:

 

S&H Medical Science Service

C/ Manuel Tovar 43, Bajo Dcha.

28034 Madrid

Phone: +34 91 535 71 83

Fax: +34 91 535 70 52
Email: abpmregistry@shmedical.es

Web: www.shmedical.es