Status:
UNKNOWN
Ambulatory Blood Pressure in HFPEF Outcomes Global Registry
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Heart Failure With Preserved Ejection Fraction
Arterial Hypertension
Eligibility:
All Genders
18-110 years
Brief Summary
Heart failure and preserved ejection fraction (HFPEF) is a disease with increasing prevalence world wide. Due to its etiological and prognostic relationship with hypertension, it is highly interesting...
Detailed Description
The prognosis of patients with heart failure and preserved ejection fraction (HF-PEF), defined by the risk of cardiovascular morbidity and mortality (hospital re-admissions, emergency room visits, fun...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT04065620
Start Date
March 1 2020
End Date
December 1 2023
Last Update
February 25 2021
Active Locations (1)
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1
Hospital Clinic
Barcelona, Spain, 08036