Prevalence of Amyloidosis in Heart Failure (PREVAMIC) (PREVAMIC)
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|ClinicalTrials.gov Identifier: NCT04066452|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : March 5, 2020
TITLE: Study of Prevalence of Amyloidosis in Heart Failure: PREVAMIC.
DESIGN: Multicenter, observational, cross-sectional, prospective, cohort study with a one-year follow-up. 44 hospitals from Spain will participate.
OBJECTIVES. PRIMARY: To estimate the current prevalence of different types of cardiac amyloidosis (CA) in patients with heart failure, aged 65 years and older, with LVH > 12 mm and any LVEF value, managed in Internal Medicine departments. SECONDARY: To describe the clinical, laboratory and echocardiographic features of patients with CA. To compare one-year readmissions and mortality rates in patients with and without CA.
INCLUSION CRITERIA: Inpatients or outpatients with heart failure, aged ≥ 65 years, both genders, under the care of internists. They should have a NYHA Class II-IV, echocardiogram performed in the previous 24 months, any value of LVEF, LVH: septum or posterior wall > 12 mm, diuretic treatment in the last 6 months and NTproBNP> 1800 pg/ml or BNP> 400 pg/ml in acute hear failure, or NT-proBNP >600 pg/ml o BNP >150 pg/ml in stable condition.
POPULATION: Heart failure outpatients or inpatients of Internal Medicine Services. It is expected to include around 450 patients.
ANALYSIS: To calculate the prevalence of TTR-CA and other types of CA. To compare the clinical, analytical, echocardiographic, and readmissions and mortality rates during one-year in patients with and without CA.
|Condition or disease||Intervention/treatment|
|Heart Failure||Diagnostic Test: Bone-cardiac scintigraphy with Tc-DPD (or similar: Tc-PYP or Tc-HMDP). Diagnostic Test: Proteinogram and serum immunoglobulins. Light chains free in serum -Freelite-. Immunofixation in serum and urine|
|Study Type :||Observational|
|Estimated Enrollment :||450 participants|
|Official Title:||Study of Prevalence of Amyloidosis in Heart Failure (PREVAMIC).|
|Actual Study Start Date :||February 3, 2020|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
Patients will be informed about the study and their written informed consent will be requested.
Once included in the study:
Diagnostic Test: Bone-cardiac scintigraphy with Tc-DPD (or similar: Tc-PYP or Tc-HMDP).
Bone-cardiac scintigraphy with Tc-DPD (or similar: Tc-PYP or Tc-HMDP) to evaluate the degree of cardiac uptake from 0 to 3 degrees.
Diagnostic Test: Proteinogram and serum immunoglobulins. Light chains free in serum -Freelite-. Immunofixation in serum and urine
Analysis to rule out the presence of monoclonal protein in blood and urine.
- Prevalence [ Time Frame: Through study completion, an average of one year. ]To estimate the current prevalence of different types of Cardiac Amyloidosis in patients with Heart Failure, age ≥ 65 years, with left ventricular hypertrophy (LVH)> 12 mm, and any LVEF value, under the care of internists in different Spanish Hospitals.
- Patients characteristics [ Time Frame: One year ]To describe the clinical, laboratory and echocardiographic features of patients with CA.
- Prognosis [ Time Frame: One year ]To compare one-year readmissions and mortality rates in patients with and without AC.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066452
|Contact: Oscar Aramburu Bodas||Aramburu Bodasfirstname.lastname@example.org|
|Contact: Oscar Aramburu Bodas||955 00 80 email@example.com|
|Hospital Universitario Virgen Macarena||Recruiting|
|Sevilla, Spain, 41071|
|Contact: Oscar Aramburu-Bodas, PhD, MD 654038491 OSCARAB2000@GMAIL.COM|
|Contact: Prado Salamanca-Bautista, PhD, MD +34 605344922 PRADOSALAMANCA@GMAIL.COM|
|Sub-Investigator: ROCÍO RUIZ-HUESO|
|Principal Investigator:||Prado Salamanca Bautista||Hospital Universitario Virgen Macarena|