Prevalence of Amyloidosis in Heart Failure (PREVAMIC)
PREVAMIC
Study of Prevalence of Amyloidosis in Heart Failure (PREVAMIC).
1 other identifier
observational
450
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2019
CompletedFirst Posted
Study publicly available on registry
August 26, 2019
CompletedStudy Start
First participant enrolled
February 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedMarch 5, 2020
August 1, 2019
1.4 years
August 20, 2019
March 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence
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.
Through study completion, an average of one year.
Secondary Outcomes (2)
Patients characteristics
One year
Prognosis
One year
Study Arms (1)
Single-group studies
Patients will be informed about the study and their written informed consent will be requested. Once included in the study: * A series of clinical, analytical and echocardiographic parameters will be collected and measured * Will be performed: * Bone-cardiac scintigraphy with Tc-DPD (or similar: Tc-PYP or Tc-HMDP) * Analytical to rule out monoclonal protein: * Proteinogram and serum immunoglobulins. * Light chains free in serum -Freelite- * Immunofixation in serum and urine. * The number of readmissions, emergency visits and mortality in the following 12 months will be recorded to compare the readmission and mortality rates in one year of patients with and without CA. * The prescribed pre- and post-diagnostic treatments will be described, according to clinical practice (without intervention). * No intervention, whether diagnostic or follow-up, that is not the usual clinical practice will be applied to patients.
Interventions
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.
Analysis to rule out the presence of monoclonal protein in blood and urine.
Eligibility Criteria
\- Heart failure outpatients or inpatients of Internal Medicine Services of 44 hospitals from Spain. Age ≥ 65 years. Both genders.
You may qualify if:
- Age ≥ 65 years.
- Both genders
- Heart failure outpatients or inpatients of Internal Medicine Services.
- Heart Failure (Criteria of HF European Guide 2016)
- Symptoms of HF
- NYHA class II to IV
- Echocardiogram performed in the previous 24 months
- FEVI: any value
- HVI: Septum or Posterior Wall \> 12 mm
- Diuretic treatment in the last 6 months
- NTproBNP \> 1800 or BNP \> 400 during any hospital admission, or NTproBNP \> 600 or BNP \> 150 in a stable situation.
You may not qualify if:
- Patients with cancer disease (solid tumor)
- Patients who are included in other studies or clinical trial
- Refusal of patients to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Virgen Macarena
Seville, 41071, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prado Salamanca Bautista
Hospital Universitario Virgen Macarena
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2019
First Posted
August 26, 2019
Study Start
February 3, 2020
Primary Completion
July 1, 2021
Study Completion
September 1, 2021
Last Updated
March 5, 2020
Record last verified: 2019-08