MedPath

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

Phase 4
Conditions
Health Condition 1: I509- Heart failure, unspecified
Registration Number
CTRI/2019/05/019284
Lead Sponsor
Dr Kunwar Shailen Dev Singh Guleria
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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/m

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

Study & Design

Study Type
PMS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Serum BNP levelsTimepoint: After three months and six months of enrollment
Secondary Outcome Measures
NameTimeMethod
EchocardiogramTimepoint: After three months and six months of enrollment
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