Study identification

EU PAS number

EUPAS105913

Study ID

108090

Official title and acronym

Impact of tafamidis in Colombian patients diagnosed with ATTR-CA in quality of life during two year of follow up

DARWIN EU® study

No

Study countries

Colombia

Study description

This study will be a non interventional, descriptive and longitudinal prospective with primary data collection that involves sites/investigators.
The patients have to be diagnosed before enrollment with ATTR-CA and prescribed with tafamidis following the the indications approved by National Institute for Drug and Food Vigilance (INVIMA) in Colombia.
The patients will be followed up from the index date untilpatient i) have deceased, ii) have decided to withdraw of the study, iii) have terminated of treatment, iv) have been lost to follow up, or, v) finalize the 24 months of following up. The index date will be defined as the date on which the first prescription of tafamidis is made.
There will be two sources of information.
Clinical and demographic information and death at the baseline will be abstracted from the medical record while the data related to hospitalizations, cardiovascular funcionality, quality of life will be collected directly from the patients using validated questionnaires and structured interviews.
Thus, in the case report form (CRF) will serve as a source document.

Study status

Ongoing
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution

Contact details

Juan Molina

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer SAS
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable