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Observational study to decide average resting Heart Rate in patients

Observational study to determine average resting Heart Rate in patients with Heart failure with reduced Ejection Fraction (HFrEF): Real World Registry (Milestone registry)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/02/031324
Enrollment
1000
Registered
2021-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I110- Hypertensive heart disease with heart failure

Interventions

None listed

Sponsors

Abbott Healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Male & female patients with Age > 18 years at baseline 2 Patients with a diagnosis of Heart Failure with Reduced Ejection Fraction(documented LVEF 3 Patients with current Class NYHA II or III 4 Patients of HFrEF being treated on an outpatient basis 5 Patients who will give consent for participation in the study

Exclusion criteria

Exclusion criteria: 1 Patients 2 Patients with Heart failure with mid-range EF (HFmrEF)(LVEF40-49%) and Heart failure with preserved EF (HFpEF)(LVEF=50%) 3 Patients of Heart failure who are currently admitted in the hospital 4 Patients with planned or history of heart transplant, Left ventricular assist device (LVAD) or dialysis 5 Patients with clinically significant condition which in the opinion of the Investigator makes him/her unfit to participate in the study 6 Patients with Major recurrent life-threatening cardiac arrhythmia 7 Patients with Atrial Fibrillation 8 Patients with implantable cardiac device like pace maker and defibrillator 9 Patients with history of terminal renal/hepatic/pulmonary disease 10 Patients as a part of any other clinical study on an Investigational Product.

Design outcomes

Primary

MeasureTime frame
Average resting HR in patients with HFrEF, on treatmentTimepoint: At baseline and at EOS

Secondary

MeasureTime frame
1)Average blood pressure in patients with HFrEF, on treatmentTimepoint: At baseline and at EOS;2) Prescription pattern of HR lowering medications – Beta blockers, Ivabradine, Digoxin and Calcium channel blockers (Non-DHPs)Timepoint: At baseline and at EOS;a) Number of patients on Beta blockers or Ivabradine or Digoxin or Calcium channel blockers (Non-DHPs)Timepoint: At baseline and at EOS;b. Number of patients on co-administration/ combination of different class of HR lowering medications (Beta blockers/ Ivabradine/ Calcium channel blockers (Non-DHPs)/ Digoxin)Timepoint: At baseline and at EOS;c. Number of patients undergoing change in ( addition/ deletion of class of drug, change of drug within the same class) heart rate lowering medicationTimepoint: At baseline and at EOS;3) Number of Patients having comorbid conditions like DM/HTN/Dyslipidemia.Timepoint: At baseline and at EOS

Countries

India

Contacts

Public ContactDr Shivani Acharya

Abbott Healthcare Private Limited

jejoe.karankumar@abbott.com7045011810

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026