Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-05 @ 10:13 PM
Study NCT ID:
NCT03709160
Status:
UNKNOWN
Last Update Posted:
2018-10-17
First Post:
2018-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral dIuretics in Very Intensive Treatment, an Early Intervention in Outpatients With Heart Failure
Sponsor:
Centro en Insuficiencia Cardiaca, Mexico
Organization:
Study Overview
Official Title:
Oral dIuretics in Very Intensive Treatment, an Early Intervention in Outpatients With Heart Failure. DIVINE STUDY
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIVINE
Brief Summary:
In the present study, consecutive patients, older than 18 years, of both genders will be included. The diagnosis of reduced Heart Failure (HfrEF) according to: Clinical pattern, laboratories and Cardiac imaging (ESC criteria). Treatment will be assigned in two groups: Bumetanide and another group will be received Indapamide. Each group received maximum tolerated dose for seven days with Clinical and labs evaluations will be every 48 hrs. (Face-to-face and/or telephone visits). Serum and urinary labs, EKG´s, Echo will be evaluated. Daily in-home register will made. Final points were: Mortality, Urinary failure, Clinical Impairment, Hospital admissions, Oedema. (MUCHO). All patients will be followed for 30 days.
Detailed Description:
In selected patients who sign informed consent with decompensation of cardiac failure by water congestion will be allocated in two groups: Bumetanide and the other Indapamide group. Each group will be given the maximum tolerated dose for seven days with clinical evaluations every 48 hours. (Face to face and/or telephone). Clinical variables, ECG and serum and urine laboratories will be assessed finally, patients will follow up for 30 days. To identify endpoints such as: mortality, urinary failure, clinical deterioration, hospital admissions, edema. (MUCHO).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: