Patients with Heart Failure withPreserved Ejection Fraction and Obesity
- Conditions
- Combined systolic (congestive) anddiastolic (congestive) heart failure,
- Registration Number
- CTRI/2022/01/039282
- Lead Sponsor
- Eli Lilly and Company India Pvt Ltd
- Brief Summary
The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 700
- Have a diagnosis of stable heart failure (NYHA class II-IV) and left ventricular ejection fraction (LVEF) ≥50%.
- Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide) > 200 pg/ml for participants without atrial fibrillation (AF), or >600 picogram/milliliter (pg/ml) for participants with AF, Structural heart disease (Left atrial enlargement) or Elevated left ventricular filling pressure.
- Estimated glomerular filtration rate (eGFR) <70 milliliter (ml)/minute (min)/1.73m² at screening, or HF decompensation within 12 months of screening.
- 4.Stable dose of heart failure medications within 4 weeks of screening.
- Body mass index (BMI) ≥30 kilograms per meter squared (kg/m²).
- 6MWD 100-425m.
- KCCQ CSS ≤80.
- Have had a major cardiovascular event within the last 90 days of screening.
- Have had acute decompensated heart failure within 4 weeks of screening.
- Have non cardiac causes of functional impairment such as pulmonary arterial hypertension (PAH), severe chronic obstructive pulmonary disease (COPD), anemia, thyroid disease, musculoskeletal disease or orthopedic conditions.
- Presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular hear disease.
- HbA1c ≥9.5% or uncontrolled diabetes.
- History of proliferative diabetic retinopathy or diabetic maculopathy.
- Have a history of pancreatitis.
- eGFR <15 mL/min/1.73 m² or requiring dialysis at screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. A Hierarchical Composite of All-Cause Mortality, Heart Failure Events, 6-minute Walk Test Distance (6MWD) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) Category. 1. 120 Weeks. | 2. Week 52 2. Change from Baseline in Exercise Capacity as Measured by 6MWD 1. 120 Weeks. | 2. Week 52
- Secondary Outcome Measures
Name Time Method 1. Percent Change from Baseline in Body Weight Loss. 2. Change from Baseline in the KCCQ CSS. Percentage of Participants with New York Heart Association (NYHA) Class Change. Week 52 Change from Baseline in 6MWD. Baseline Week 24
Trial Locations
- Locations (10)
AIG Hospitals
🇮🇳Hyderabad, TELANGANA, India
Batra Hospital and Medical Research Centre
🇮🇳Delhi, DELHI, India
Central India Cardiology and Research Institute
🇮🇳Nagpur, MAHARASHTRA, India
CIMS Hospital - Care Institute of Medical Sciences
🇮🇳Ahmadabad, GUJARAT, India
G.B. Pant Institute of Postgraduate Medical Education & Research
🇮🇳Delhi, DELHI, India
Government Medical College And Hospital - Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
🇮🇳Mumbai, MAHARASHTRA, India
Medanta The Medicity
🇮🇳Gurgaon, HARYANA, India
Narayana Institute of Cardiac Sciences
🇮🇳Bangalore, KARNATAKA, India
Vijan Hospital and Research Centre
🇮🇳Nashik, MAHARASHTRA, India
AIG Hospitals🇮🇳Hyderabad, TELANGANA, IndiaDr Narasimhan CalamburPrincipal investigator9618528340calambur1@gmail.com