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Prevalence of Amyloidosis in Heart Failure (PREVAMIC)

NCT04066452 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2020-03-05

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Prado Salamanca Bautista · Hospital Universitario Virgen Macarena

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-03
Primary Completion
2021-07-01
Completion
2021-09-01

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04066452 on ClinicalTrials.gov