Prevalence of Amyloidosis in Heart Failure (PREVAMIC) (PREVAMIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066452
|Contact: Oscar Aramburu Bodas||Aramburu Bodasemail@example.com|
|Contact: Oscar Aramburu Bodas||955 00 80 firstname.lastname@example.org|
|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|