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To compare safety and effectiveness of combination of sacubitril and valsartan with telmisartan in patients suffering from heart failure.

To compare the safety & efficacy of Sacubitril and Valsartan vs Telmisartan monotherapy in patients of CHF with reduced ejection fraction - COSAVATEL-HF

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/05/019284
Enrollment
60
Registered
2019-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: I509- Heart failure, unspecified

Interventions

Intervention1: Sacubitril and Valsartan: 200mg BD, Oral for minimum 6 months Control Intervention1: Telmisartan: 40mg OD, Oral for minimum 6 months

Sponsors

Dr Kunwar Shailen Dev Singh Guleria
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient of CHF with decreased ejection fraction 2. Adult patients of either sex, consenting for study 3. If no HF hospitalizations in prior year: BNP greater than or equal to 150 pg/mL 4. If a HF hospitalization in prior year: BNP greater than or equal to 100 pg/mL

Exclusion criteria

Exclusion criteria: 1. Unwilling patient. 2. Pregnant females. 3. Estimated glomerular filteration rate less than 30ml/min/1.73m2 4. Serum potassium greater than 5.2mmol/L 5. Symptomatic hypotensive patients 6. SBP less than 100mmHg at screening or less than 95mmHg at randomization 7.Patient with known history of angioedema 8. Patient on drugs that might interact with ARNI/ARBs 9. Patient with structural (valvular) heart disease. 10.Unacceptable side effects with ACE-inhibitors or ARBs

Design outcomes

Primary

MeasureTime frame
Serum BNP levelsTimepoint: After three months and six months of enrollment

Secondary

MeasureTime frame
EchocardiogramTimepoint: After three months and six months of enrollment

Countries

India

Contacts

Public ContactDr Atal Sood

Dr Rajendra Prasad Govt. Medical College Kangra at Tanda

dinesh.kansal56@gmail.com9418454624

Outcome results

None listed

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