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This study will compare the outcomes of Vericuguat and placebo in patient with decompensated heart failure . This study will carry out after approval from IERB. Seventy patients fulfilling the inclusion criteria will be enrolled from emergency department. Informed consent will be taken from attendants. A detailed history including name, age, gender, duration of heart failure, history of alcoholism, smoking, diabetes, hypertension, EF at baseline and NYHA class will be noted. Patients will be randomly divided in two groups by using lottery method. Outcomes will be assessed at in terms of hospitalization for heart failure, death from cardiovascular event and side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A patients who will be prescribed 2.5 mg of vericiguat along with standard treatment | Experimental | Sixty Five patients fulfilling the inclusion criteria will be enrolled from emergency department. Informed consent will be taken from attendants. A detailed history will be noted. patients will be prescribed 2.5 mg of vericiguat. Dose will be increased to 5 mg and ultimately to the target dose of 10 mg once daily, as guided by evaluation of blood pressure and clinical symptoms along with standard treatment (sacubitril-valsartan).All patients will be followed-up in OPD for 3 months. During follow-up, patients will be examined for admission to the hospital for deterioration of heart condition or mortality due to cardiac event and side effects (as per operational definition). All the data will be recorded in Performa. |
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| Group B patients who will be prescribed standard treatment only (sacubitril-valsartan) | Active Comparator | Sixty Five patients fulfilling the inclusion criteria will be enrolled from emergency department randomly. Informed consent will be taken from attendants. A detailed history will be noted. Patients will be prescribed standard treatment only (sacubitril-valsartan). All patients will be followed-up in OPD for 3 months. During follow-up, patients will be examined for admission to the hospital for deterioration of heart condition or mortality due to cardiac event and side effects (as per operational definition). All the data will be recorded in Performa. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vericiguat tablet | Drug | Group A, patients will be prescribed 2.5 mg of vericiguat. Dose will be increased to 5 mg and ultimately to the target dose of 10 mg once daily, as guided by evaluation of blood pressure and clinical symptoms along with standard treatment (sacubitril-valsartan) |
| Measure | Description | Time Frame |
|---|---|---|
| Requirement of hospitalization for heart failure | If Ejection Fraction further reduced and patient need to admit in the hospital for symptoms including pedal edema, pleural effusion, and need intravenous diuretic therapy | 03 months |
| Death from cardiovascular event | If patient will die during 3 months follow-up | 03 months |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | If patient will complaint of mild to moderate gastrointestinal disturbances, Hypotension (BP≥100/60 mmHg) or any other adverse event during 3 months follow-up | 03 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Khawaja Danish Ali, MBBS | Contact | +923448890893 | khawajadanishali@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Armed Forces Institute of Cardiology. Pakistan | Recruiting | Rawalpindi | Punjab Province | 46000 | Pakistan |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C000603960 | vericiguat |
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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| Sacubitril / Valsartan | Drug | Group A Patients it will be prescribed along with vericiguat but group B patients will have (sacubitril-valsartan) as standard treatment |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |